Cardiovascular and osteoporosis protection at menopause with lycopene: A placebo-controlled double-blind randomized clinical trial

Meeta Meeta; Sudhaa Sharma; Jyothi Unni; Sunila Khandelwal; Ambuja Choranur; Sonia Malik

doi:10.4103/jmh.jmh_61_22

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ORIGINAL ARTICLE

Year : 2022 | Volume : 13 | Issue : 1 | Page : 50-56

Cardiovascular and osteoporosis protection at menopause with lycopene: A placebo-controlled double-blind randomized clinical trial

Meeta Meeta¹, Sudhaa Sharma², Jyothi Unni³, Sunila Khandelwal⁴, Ambuja Choranur⁵, Sonia Malik⁶
¹ Department of Gynaecologist, Tanvir Hospital, Hyderabad, Telangana, India
² Department of Gynaecologist, Jammu and Kashmir, India
³ Department of Gynaecologist, Jehangir Hospital, Pune, Maharashtra, India
⁴ Department of Gynaecologist, Mid-life Women Health Care and Menopause Centre, Fortis Escorts and Apex Hospital, Jaipur, Rajasthan, India
⁵ Department of Gynaecologist, Osmania Medical College, Hyderabad, Telangana, India
⁶ Fertility Specialist, Southend Fertility and IVF Centre, New Delhi, India

Correspondence Address:
Meeta Meeta
Tanvir Hospital, Hyderabad, Telangana
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/jmh.jmh_61_22

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.

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