Amstrup · Clinical endocrinology 2016 · double-blind randomized placebo-controlled trial · n=81

Reduced fat mass and increased lean mass in response to 1 year of melatonin treatment in postmenopausal women: A randomized placebo-controlled trial.

Cited 90 times in the scientific literature.

Level 2 - randomized trial

Individual double-blind randomized controlled trial

PubMed 26352863 · doi:10.1111/cen.12942 · record verified 2026-08-29

What was done

In a double-blind, placebo-controlled trial, 81 postmenopausal women were randomized to receive 1 year of nightly melatonin (1 mg or 3 mg) or placebo. Body composition was assessed at baseline and after 1 year using dual-energy X-ray absorptiometry (DXA). Blood markers including leptin, adiponectin, insulin, and markers of glucose homeostasis were also evaluated.

What was found

Compared to placebo, melatonin treatment resulted in a 6.9% decrease in fat mass (95% CI: 1.4% to 12.4%, P = 0.02). Lean mass showed a borderline increase overall (5.2% vs placebo, P = 0.08) that became statistically significant after adjusting for BMI (2.6% increase, 95% CI: 0.1% to 5.0%, P = 0.04). Changes in total body weight and BMI did not differ between groups. Adiponectin showed a borderline increase of 21% (P = 0.08), with no significant changes observed for leptin, insulin, or markers of glucose homeostasis.

Why it matters

This study provides randomized human evidence that 1 year of nightly melatonin supplementation may favorably shift body composition by reducing fat mass and increasing lean mass in postmenopausal women, independent of total weight change.

Limits

The study was small (81 participants) and exclusively conducted in postmenopausal women, limiting generalizability to other populations. The abstract pools results for the 1 mg and 3 mg doses without reporting dose-specific outcomes, and findings for adiponectin and unadjusted lean mass reached only borderline statistical significance.

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