What is lycopene ?

What is Lycopene

Lycopene (molecular formula: C40H56) is a linear, unsaturated hydrocarbon carotenoid, the major bright red pigment, a phytochemical found in fruits such as tomatoes and other red fruits such as papaya, pink grapefruit, apricots, red oranges, watermelon, rosehips and guavas ³⁾. Lycopene is the most common carotenoid in the human body and is one of the most potent carotenoid antioxidants and scavenger of free radicals and have also been shown to be a hypolipaemic agent, inhibitor of pro-inflammatory and pro-thrombotic factors ⁴⁾, ⁵⁾. Its name is derived from the tomato’s species classification, Solanum lycopersicum ⁶⁾.

In North America, 85% of dietary lycopene comes from tomato products such as tomato juice or paste. One cup (240 mL) of tomato juice provides about 23 mg of lycopene ⁷⁾. Processing raw tomatoes using heat (in the making of tomato juice, tomato paste or ketchup, for example) actually changes the lycopene in the raw product into a form that is easier for the body to use. The lycopene in supplements is about as easy for the body to use as lycopene found in food.

• Lycopene’s absorption is improved with concurrent dietary fat intake, this is because lycopene is fat soluble and oil in tomato sauce, for example, makes it ideal for absorbing lycopene. There is evidence that dietary fat may help increase the absorption of carotenoids, including lycopene. In one experiment, healthy volunteers consumed mixed-vegetable salads with nonfat, low-fat, or full-fat salad dressing. Analysis of blood samples indicated that eating full-fat salad dressing led to more carotenoid absorption than eating low-fat or nonfat dressing. Results of a randomized study published in 2005 demonstrated that cooking diced tomatoes with olive oil significantly increased lycopene absorption compared with cooking tomatoes without olive oil. In another study, there was no difference in plasma lycopene levels following consumption of tomatoes mixed with olive oil or tomatoes mixed with sunflower oil, suggesting that absorption of lycopene may not be dependent on the type of oil used. However, this study found that combining olive oil, but not sunflower oil, with tomatoes resulted in greater plasma antioxidant activity.

Lycopene has been investigated for its role in chronic diseases, including cardiovascular disease and cancer. Numerous epidemiological studies suggest that lycopene may help prevent cardiovascular disease. Lycopene may protect against cardiovascular disease by decreasing cholesterol synthesis and increasing the degradation of low-density lipoproteins ⁸⁾, although some interventional studies have shown mixed results ⁹⁾.

A number of in vitro and in vivo studies suggest that lycopene may also be protective against cancers of the skin, breast, lung, and liver ¹⁰⁾. However, epidemiological studies have yielded inconsistent findings regarding lycopene’s potential in reducing cancer risk.

The few human intervention trials have been small and generally focused on intermediate endpoints and not response of clinically evident disease or overall survival and thus have limited translation to practice ¹¹⁾, ¹²⁾. A Cochrane Review in 2011 concluded there is insufficient evidence to either support, or refute, the use of lycopene for the prevention of prostate cancer. Similarly, there is no robust evidence from randomised controlled trials to identify the impact of lycopene consumption upon the incidence of prostate cancer, prostate symptoms, PSA levels or adverse events ¹³⁾.

On the basis of overall evidence, the association between tomato consumption and reduced risk of prostate cancer is limited ¹⁴⁾.

Lycopene Chemistry

Lycopene (ψ,ψ-carotene), one of more than 600 carotenoids synthesized by plants and photosynthetic microorganisms ¹⁵⁾, is a tetraterpene hydrocarbon containing 40 carbon atoms and 56 hydrogen atoms with a molecular mass of 536 ¹⁶⁾.

The bioavailability of lycopene has been examined and demonstrated in several studies relating lycopene to prostate cancer and other diseases. The bioavailability of lycopene is greater in processed tomato products, such as tomato paste and tomato puree, than in raw tomatoes ¹⁷⁾. Lycopene bioavailability has been observed to be highly variable, which may lead to varying biological effects after lycopene consumption. Healthy males participated in a crossover design study that attempted to differentiate the effects of a tomato matrix from those of lycopene by using lycopene-rich red tomatoes, lycopene-free yellow tomatoes, and purified lycopene. Thirty healthy men aged 50 to 70 years were randomly assigned to two groups with each group consuming 200 g/d of yellow tomato paste (lycopene, 0 mg) and 200 g/d of red tomato paste (lycopene, 16 mg) as part of their regular diet for 1 week, separated by a 2-week washout period. Then, in a parallel design, the first group underwent supplementation with purified lycopene (16 mg/d) for 1 week, whereas the second group received a placebo. Sera samples collected before and after the interventions were incubated with lymph node cancer prostate cells to measure the expression of 45 target genes. In this placebo-controlled trial, circulating lycopene concentration increased only after consumption of red tomato paste and purified lycopene.

Lycopene is a phytochemical that belongs to a group of pigments known as carotenoids. It is red and lipophilic. As a natural pigment made by plants, lycopene helps to protect plants from light-induced stress ¹⁸⁾ and it also transfers light energy during photosynthesis ¹⁹⁾. Lycopene is found in a number of fruits and vegetables, including apricots, guavas, and watermelon, but the majority of lycopene consumed in the United States is from tomato-based products ²⁰⁾.

Unlike beta-carotene, lycopene lacks a beta-ionone ring and therefore has no pro-vitamin A activity ²¹⁾. However, the 11 conjugated and two non-conjugated double bonds in lycopene make it highly reactive towards oxygen and free radicals, and this anti-oxidant activity probably contributes to its efficacy as a chemoprevention agent ²²⁾.

Lycopene Health Benefits

Lycopene inhibits androgen receptor expression in prostate cancer cells in vitro and along with some of its metabolites, reduces prostate cancer cell proliferation and may modulate cell-cycle progression ²³⁾.

Lycopene may also affect the insulin-like growth factor (IGF) intracellular pathway in prostate cancer cells.

Results from several in vitro and animal studies have indicated that lycopene may have chemopreventive effects for cancers of the prostate, skin, breast, lung, and liver; however, human trials have been inconsistent in their findings.

The recommended intake is at least 10mg of lycopene per day—from food. And tomato-based products do, give you the most bang for your buck.

Clinical trials utilizing lycopene in prostate cancer patients with various different clinical presentations (e.g., early stage, prostate-specific antigen (PSA) relapse, advanced disease) have yielded inconsistent results.

The U.S. Food and Drug Administration (FDA) has accepted the determination by various companies that their lycopene-containing products meet the FDA’s requirements for the designation of Generally Recognized as Safe (GRAS). In clinical trials involving prostate cancer patients, doses ranging from 10 to 120 mg/d have been well tolerated, with only occasional mild-to-moderate gastrointestinal toxicities.

Lycopene Possibly Ineffective ²⁴⁾ for:

• Bladder cancer. Research suggests that there is no link between lycopene consumption in the diet or lycopene blood levels and the risk for bladder cancer.

• Diabetes. Research suggests that increased lycopene consumption in the diet does not decrease the risk of developing diabetes.

Insufficient evidence to rate effectiveness ²⁵⁾ for:

• Age-related eye disease (age-related maculopathy). Research on the effect of lycopene in age-related eye disease is inconsistent. Some evidence suggests that people with low lycopene levels are almost twice as likely to develop age-related eye disease compared to people with high levels. However, other research suggests that there is no link between lycopene levels or lycopene intake and the risk of age-related eye disease.

• Asthma. Research on the effects of lycopene in people with asthma is inconsistent. Taking lycopene does not seem to reduce asthma symptoms in adults with stable asthma. However, in people with a history of exercise-induced asthma, taking a specific lycopene product (LycoMato, LycoRed Corp., Orange, NJ) seems to improve lung function after exercise.

• Hardening of the arteries (atherosclerosis). There is some evidence showing that higher lycopene blood levels is associated with a reduced risk of hardening of the arteries. There is also early evidence that higher lycopene blood levels can reduce the risk of heart disease associated with hardening of the arteries. However, there does not appear to be a link between lycopene levels and stroke risk.

• Enlarged prostate (benign prostatic hypertrophy). Early research shows that taking lycopene can slow the progression of prostate enlargement and can improve symptoms in people with this condition. However, other research found no link between lycopene intake in the diet and the development of an enlarged prostate.

• Breast cancer. Research about how lycopene affects breast cancer risk is inconsistent. Some evidence suggests that having higher lycopene blood levels is associated with a lower risk of breast cancer. However, other research shows that neither lycopene intake nor lycopene blood levels are linked to breast cancer risk.

• Heart disease. Some research shows that women with higher levels of lycopene in their blood have a lower risk of developing heart disease. However, other research shows no link between lycopene intake and the risk of heart attack or stroke in women. Also, increasing dietary lycopene does not seem to prevent heart attacks in men at low risk for heart disease.

• Cataracts. One study suggests that higher lycopene blood levels are associated with a lower risk of developing cataracts. However, other studies have found no link between lycopene intake or lycopene blood levels and the risk of developing cataracts.

• Cervical cancer. Research about how lycopene affects the risk of cervical cancer is inconsistent. Some evidence suggests that higher lycopene blood levels or higher lycopene intake in the diet is linked to a lower risk of cervical cancer. Other studies have not found this link.

• Colorectal cancer. Research about how lycopene affects the risk of colorectal cancer is inconsistent. Some research suggests that people with high lycopene intake in the diet are less likely to develop colorectal cancer than those with low intake. However, other research shows no link between lycopene intake and the risk of colorectal cancer.

• Gingivitis. Early research shows that taking a specific lycopene supplement by mouth (LycoRed, Jagsonpal Pharmaceuticals) for 2 weeks or receiving a single injection of lycopene gel into the gums reduces gingivitis.

• Brain tumor (giloma). Early research shows that taking lycopene by mouth for 3 months does not improve the response to radiotherapy and chemotherapy in people with brain tumors.

• Ulcers caused by H. pylori infection. Early research shows that taking lycopene by along with antibiotics does not help treat H. pylori infection compared to taking antibiotics alone.

• Human papilloma virus (HPV) infection. Women with higher levels of lycopene in their blood seem to recover from cancer-associated HPV infection faster than women with lower lycopene blood levels.

• High cholesterol. Early research shows that taking a specific lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) by mouth daily for 6 months lowers total cholesterol and low-density lipoprotein (LDL or “bad”) cholesterol, and increases high-density lipoprotein (HDL or “good”) cholesterol. However, other evidence suggests that lycopene does not affect cholesterol levels in healthy adults or in those with heart disease.

• High blood pressure. Early research shows that taking a specific lycopene product (LycoMato, LycoRed Corp., Organge, NJ) daily for 8 weeks lowers blood pressure in people with high blood pressure. However, other research suggests that there is no link between lycopene blood levels and the risk of developing high blood pressure.

• Lung cancer. Research about how lycopene affects the risk of lung cancer is inconsistent. Some research shows that lower lycopene intake in the diet is linked to an increased risk of lung cancer. However, other research suggests that there is no link between lycopene consumption in the diet or lycopene blood levels and lung cancer risk.

• Male fertility problems. Early research shows that taking lycopene by mouth daily for 3 months improves sperm quality in some men with fertility problems due to unknown causes.

• Menopausal symptoms. Early research shows that taking a specific product containing lycopene, calcium, vitamin D3, astaxanthin, and citrus bioflavonoids daily for 8 weeks reduces menopausal symptoms including hot flashes, joint pain, anxiety, and depression.

• White pre-cancerous patches in the mouth (oral leukoplakia). Early research shows that taking a specific lycopene supplement by mouth twice daily improves white pre-cancerous patches in the mouth.

• Ulcers and swelling in the mouth (oral mucositis). Early research shows that taking lycopene by mouth daily for 2 months improves ulcerations in the mouth in people with oral mucositis.

• Ovarian cancer. There is inconsistent evidence about the effect of lycopene on ovarian cancer risk. Some research shows that a diet rich in carotenoids, including lycopene, seems to help prevent ovarian cancer in young (premenopausal) women. However, other research shows that the risk of developing ovarian cancer is not linked to lycopene blood levels.

• Pancreatic cancer. Some early research shows that a diet high in lycopene, primarily from tomatoes, seems to lower the risk of developing pancreatic cancer.

• High blood pressure during pregnancy. Research on the effect of lycopene for preventing high blood pressure during pregnancy is unclear. Some research shows that taking a specific lycopene supplement twice daily starting between weeks 16 and 20 of pregnancy and continuing until delivery lowers blood pressure and reduces associated complications. However, other research suggests that lycopene does not affect blood pressure during pregnancy.

• Prostate cancer. Research on the effects of lycopene for preventing or treating prostate cancer is inconsistent. Some research suggests that increasing lycopene consumption in the diet, or higher lycopene blood levels, is linked with a lower risk of developing prostate cancer. However, other research shows no link between lycopene intake or blood levels and prostate cancer risk. In addition, early research in men with precancerous changes in their prostate shows that taking lycopene supplements might delay or prevent the progression to prostate cancer. However, in other research, taking lycopene daily for up to one year did not seem to help treat prostate cancer.

• Prostate swelling and pelvic pain. Early research shows that taking a specific combination of lycopene, selenium, and saw palmetto by mouth for 8 weeks reduces pain in men with prostate swelling and pelvic pain compared to saw palmetto alone.

• Kidney cancer (renal cell carcinoma). Early research shows no link between lycopene consumption in the diet and the risk of developing kidney cancer.

• Sunburn. Early research shows that taking lycopene by mouth, alone or together with other ingredients, might protect against sunburn.
• Other conditions.

More evidence is needed to rate lycopene for these uses.

Lycopene Health Benefits for Men

Past research, has shown that a diet rich in lycopene-containing foods may help lower the risk of prostate and other cancers. Now, in a report just published in the journal Neurology, a team of Finnish researchers has linked lycopene levels in the blood to stroke protection ²⁶⁾. They made this connection after following more than a thousand middle-aged men for 12 years. Men with the greatest amounts of lycopene in their blood had a 55% lower chance of having any kind of stroke. The lycopene connection was even stronger (59%) when it came to protecting against strokes due to blood clots (the most common kind) ²⁷⁾. The researchers suggested that lycopene, in addition to its ability to attack free radicals, may also reduce inflammation and cholesterol, improve immune function, and prevent blood from clotting. All of these may help reduce ischemic strokes, which are caused by clot-caused blockages in blood flow to the brain. How the added that larger studies are needed to confirm the findings and to figure out if the stroke protection is due to lycopene or healthy lifestyle habits, because a high lycopene consumer is likely to eat more vegetables and not be a smoker ²⁸⁾.

For cancers, as pointed by the FDA (see below), “there was no credible evidence to support qualified health claims for tomatoes or tomato-based foods and a reduced risk for lung, colorectal, breast, cervical, or endometrial cancer. FDA further concluded that there was no credible evidence to support qualified health claims for lycopene, as a food ingredient, component of food, or as a dietary supplement, and a reduced risk of any of these cancers. Thus, FDA denied these claims. FDA concluded that there was very limited credible evidence for qualified health claims for tomatoes and/or tomato sauce and a reduced risk for prostate, gastric, ovarian, and pancreatic cancers provided that the qualified health claims were appropriately worded so as to not mislead consumers” ²⁹⁾.

Lycopene, Cancers and U.S. Food and Drug Administration (FDA) Conclusion

In 2004, FDA received two petitions for qualified health claims regarding tomatoes and/or lycopene and cancer risk reduction from The Lycopene Health Claim Coalition (consisting of H. J. Heinz Company, LycoRed Natural Products Industries, Ltd, The Morningstar Company, and The Prostate Cancer Foundation) and American Longevity, Inc. Both petitioners requested that FDA evaluate the relationship between tomato and/or lycopene consumption and prostate cancer risk. One petitioner also requested that FDA review the relationship between tomato and/or lycopene consumption and the risks of other forms of cancer, including lung, colorectal, gastric, breast, cervical, ovarian, endometrial, and pancreatic cancers. In response to these petitions, FDA evaluated evidence for associations between lycopene (a food component) and tomatoes (a food) separately and each form of cancer.

Based on the scientific evidence, FDA concludes that there is no credible evidence to support a qualified health claim for tomato lycopene; tomatoes and tomato products, which contain lycopene; lycopene in tomatoes and tomato products; lycopene in fruits and vegetables, including tomatoes and tomato products, and lycopene as a food ingredient, a component of food, or as a dietary supplement and reduced risk of prostate cancer ³⁰⁾.

The FDA found no credible evidence to support an association between lycopene intake and a reduced risk of prostate, lung, colorectal, gastric, breast, ovarian, endometrial, or pancreatic cancer ³¹⁾. The FDA also found no credible evidence for an association between tomato consumption and a reduced risk of lung, colorectal, breast, cervical, or endometrial cancer. The FDA found very limited evidence to support an association between tomato consumption and reduced risks of prostate, ovarian, gastric, and pancreatic cancers ³²⁾.

On November 8, 2005, FDA issued letters of enforcement discretion for these qualified health claims ³³⁾.

Prostate Cancer

“Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim” ³⁴⁾.

Gastric Cancer

“Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.”

Ovarian Cancer

The qualified health claim for ovarian cancer was “One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer.”

Pancreatic Cancer

The qualified health claim for pancreatic cancer was “One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer.”

Lung Cancer

The evidence for a relationship between tomato or tomato-based foods intake and a reduced risk of lung cancer is from one cohort study, one sub-cohort study and one nested case-control study. None of these 3 studies supported a relationship between tomato or tomato-based food intake and lung cancer risk reduction. Based on the above, FDA concludes that there is no credible evidence supporting a relationship between tomato or tomato-based food consumption and lung cancer.

Breast Cancer

The evidence for a relationship between tomato intake and reduced risk of breast cancer is based on two case control studies. Neither of the studies found a relationship between tomato or tomato-based food intake and breast cancer risk. Based on the above, FDA concludes that there is no credible evidence supporting a relationship between tomato or tomato-based food consumption and breast cancer.

Colorectal Cancer

The evidence for a relationship between tomato or tomato-based food consumption and reduced risk of colorectal cancer is based on two case-control studies from the United States and Italy. Neither case-control study found a relationship between tomato or pizza consumption and colorectal cancer risk reduction. Based on the above, FDA concludes that there is no credible evidence supporting a relationship between tomato or tomato-based food consumption and colorectal cancer.

Endometrial Cancer

There were no studies that evaluated the relationship of tomatoes or tomato-based foods and endometrial cancer risk. Based on the above, FDA concludes that there is no credible evidence supporting a relationship between tomato or tomato-based food consumption and endometrial cancer.

Cervical Cancer

There was one observational study that showed that the consumption of tomatoes was not significantly different between control and cervical cancer cases and no studies showing a relationship between tomatoes or tomato-based foods and risk of cervical cancer. Therefore, FDA concludes that there is no credible evidence to support a relationship between the consumption of tomatoes or tomato-based foods and cervical cancer risk.

Lycopene Foods

For a more comprehensive list of over 5366 foods containing lycopene, please go to the United States Department of Agriculture Food Composition Databases here: ³⁵⁾

https://ndb.nal.usda.gov/ndb/nutrients/report/nutrientsfrm?max=25&offset=0&totCount=0&nutrient1=337&nutrient2=&nutrient3=&subset=0&fg=&sort=c&measureby=m

There’s no evidence of lycopene toxicity from diet.

• Tomatoes
• Ppapaya,
• Pink grapefruit,
• Apricots,
• Red oranges,
• Watermelon,
• Rosehips
• Guavas
• Sweet Red Peppers

Table 1. Top lycopene-containing foods

Food	Milligrams of lycopene (mg)
½ cup canned tomato puree	27.19
1 cup canned tomato juice	21.96
1 wedge of raw watermelon	12.96
½ cup ready-to-serve marinara sauce	6.68
1 tablespoon canned tomato paste	3.14
1 tablespoon catsup	2.50
½ pink or red grapefruit	1.74
1 tablespoon salsa	1.68
One sun-dried tomato	0.91
One slice of raw tomato	0.51
One cherry tomato	0.43

[Source ³⁶⁾]

Lycopene supplement

Many studies suggest that eating lycopene-rich foods or having high lycopene levels in the body may be linked to reduced risk of cancer, heart disease, and age-related eye disorders. However, measures of lycopene intake have been based on eating tomatoes, not on the use of lycopene supplements.

Lycopene Supplements may give you a purified form of lycopene, but you’re not sure you’re getting what you get from food. Since tomatoes also contain other nutrients, such as vitamin C and potassium, the potential benefits of lycopene alone are still unclear. Furthermore, you may be getting the wrong form of lycopene in a supplement. There are also a lot of compounds in food that aren’t lycopene but that are similar, and some of those molecules may be part of what makes lycopene so beneficial ³⁷⁾.

• Lycopene deficiency is not considered a medical condition. There is a lack of evidence on whether increasing low lycopene levels may benefit health.

The appropriate dose of lycopene depends on several factors such as the user’s age, health, and several other conditions. At this time there is not enough scientific information to determine an appropriate range of doses for lycopene. Keep in mind that natural products are not always necessarily safe and dosages can be important. Be sure to follow relevant directions on product labels and consult your pharmacist or physician or other healthcare professional before using.

Lycopene is likely safe when taken by mouth in appropriate amounts. Daily supplements containing up to 120 mg of lycopene have been used safely for up to one year.

Doses of lycopene ranging between 8 mg and 45 mg administered over a period ranging from 3 weeks to 2 years have been reported to be safe in randomized clinical trials targeting the prostate. When adverse effects occurred, they tended to present as gastrointestinal symptoms and, in one study, the symptoms resolved when lycopene was taken with meals. Another study reported that one participant withdrew because of diarrhea.

As an antioxidant, lycopene has been taken by mouth in doses of 6.5, 15, and 30 milligrams daily for eight weeks. Lyc-O-Mato® capsules (each containing up to 15 milligrams) have been taken by mouth once daily for eight weeks and 26 days, or twice daily for four months. Two capsules of LycoRed® (each containing 15 milligrams of lycopene) have been taken by mouth once daily for 21 days ³⁸⁾.

To treat asthma caused by exercise, 30 milligrams of lycopene in the form of Lyc-O-Mato® has been taken by mouth daily for one week ³⁹⁾.

To treat coronary artery disease, 1.24 grams of six-percent lycopene oleoresin capsules (LycoRed®) has been taken by mouth daily for one week. Two LycoRed® softules (each containing 2,000 micrograms of lycopene) have been taken by mouth daily for six months. Lycopene has been taken by mouth in the form of tomato products, capsules, and Lyc-O-Mato® in doses of 39.2-80 milligrams for 1-12 weeks ⁴⁰⁾.

To treat enlarged prostate, 15 milligrams of lycopene (LycoVit®) has been taken by mouth daily for six months ⁴¹⁾.

To treat brain tumors, eight milligrams of lycopene has been taken by mouth daily for three months ⁴²⁾.

To treat heart disease, lycopene has been taken by mouth in the form of tomato products, capsules, and Lyc-O-Mato® in doses of 39.2-80 milligram doses daily for 1-12 weeks ⁴³⁾.

To treat gum disease, LycoRed® (providing eight milligrams of lycopene) has been taken by mouth daily in divided doses for two weeks ⁴⁴⁾.

To treat high blood pressure, lycopene has been taken by mouth in 4-44-milligram doses daily for up to six months. Lyc-O-Mato®, containing 15 milligrams of lycopene, has been taken by mouth daily for six weeks and eight weeks. A dose of 250 milligrams of Lyc-O-Mato® has been taken by mouth for eight weeks ⁴⁵⁾.

To treat infertility, 2,000 micrograms of lycopene has been taken by mouth twice daily for three months ⁴⁶⁾.

To lower lipid levels, lycopene has been taken by mouth in 4-44-milligram doses daily for up to six months. Two LycoRed® softules (each containing 2,000 micrograms of lycopene) have been taken by mouth daily for six months ⁴⁷⁾.

To treat mouth sores, LycoRed®, containing 4-8 milligrams of lycopene, has been taken by mouth daily for three months in two divided doses ⁴⁸⁾.

To treat inflammation of the mouth, 16 milligrams of lycopene has been taken by mouth daily in two divided doses for two months ⁴⁹⁾.

To prevent ovarian cancer, 4,000 micrograms of lycopene has been taken by mouth daily ⁵⁰⁾.

To treat high blood pressure associated with pregnancy, LycoRed® (containing two milligrams of lycopene per capsule) has been taken once or twice daily until delivery ⁵¹⁾.

• Pregnancy and breast-feeding: Lycopene is likely safe during pregnancy and breast-feeding when taken in amounts commonly found in foods ⁵²⁾. However, lycopene is POSSIBLY UNSAFE when taken as a supplement during pregnancy. A study using a specific lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) found that taking 2 mg daily, starting between weeks 12 and 20 of pregnancy and continuing until delivery, increased the rate of premature births and low-birth-weight babies. Not enough is known about the safety of lycopene supplements during breast-feeding ⁵³⁾. If you are pregnant or breast-feeding, avoid using lycopene in amounts greater than those typically found in foods.

To prevent or treat prostate cancer, two milligrams of lycopene has been taken by mouth twice daily, and four milligrams of lycopene has been taken by mouth twice daily for one year. Lyc-O-Mato®, containing up to 120 milligrams of lycopene, has also been taken by mouth in divided doses twice daily for periods of up to one year. LycoRed® softules, providing a total daily dose of 10 milligrams of lycopene, have been taken daily for three months.

• Prostate cancer: Developing laboratory research suggests lycopene might worsen established prostate cancer by increasing the spread of cancer without having any effect on cancer cell growth. Until more is known, avoid lycopene if you have a prostate cancer diagnosis ⁵⁴⁾.

To protect skin from sun damage, 55 grams of tomato paste in olive oil (providing 16 milligrams of lycopene) has been taken by mouth daily for 12 weeks ⁵⁵⁾.

Children (younger than 18 years) : There is no proven safe or effective dose for lycopene in children ⁵⁶⁾.