Cardiovascular and Osteoporosis Protection at Menopause with Lycopene: A Placebo-Controlled Double-Blind Randomized Clinical Trial.

OBJECTIVE

The effect of lycopene (LycoRed) supplementation was evaluated in healthy postmenopausal women by biochemical markers for cardiovascular protection and osteoporosis protection.

STUDY SETTINGS AND DESIGN

This was a multi-centric placebo-controlled double-blind randomized clinical trial that screened 198 postmenopausal women at 21 centers across 12 cities in India. Levels of lycopene, lipid profile, high-risk C-reactive protein, and bone turnover markers: amino-terminal propeptide of Type I collagen (P1NP) and C-terminal telopeptide of Type I collagen (β-CTx) were measured at baseline and 6 months postsupplementation with LycoRed or placebo.

INTERVENTIONS

The study was completed with 57 of the 100 women on LycoRed 8 mg (antioxidant potency is equivalent to 24 mg of lycopene) and 43 placebos for 6 months by randomization.

MAIN OUTCOME MEASURES

Rise in serum lycopene and effect of serum lycopene on surrogate markers of cardiovascular health and bone health.

RESULTS

LycoRed supplementation increases lycopene levels and P1NP and nonsignificant fall in β-CTx levels in healthy postmenopausal women.

CONCLUSIONS

Lycopene supplementation in Indian menopausal women may confer protection from osteoporosis as shown by the directional change in the surrogate biochemical markers. This study can form a basis for larger studies with different doses to understand the effect of lycopene to prevent and act as adjuvant treatment on clinical endpoints for cardiovascular disease (CVD) and bone health.