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A Clinical Trial to Assess the Safety and Efficacy of a Dietary Supplement Purported to Increase Plasma Sex Hormones
Author(s) -
Kalman Douglas,
Feldman Samantha,
Oxford Sharon,
Krieger Diane
Publication year - 2011
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.25.1_supplement.29.6
Subject(s) - hormone , dietary supplement , clinical trial , medicine , plasma concentration , environmental health , physiology , biology , food science
The objective of this open label, dose finding exploratory trial was to investigate the efficacy and safety of 3 doses of Viridex XT™ in healthy males. Ten subjects (28.4 ± 8.1 years) were randomly assigned in a 3:3:3:1 ratio (2, 4, 6/day product or placebo). Subjects were evaluated every 2 weeks over a 30‐day period with a final evaluation 10 days post product cessation. Levels of total and free testosterone (TT), estradiol, and luteinizing hormone (LH) were measured and changes in lean body mass (LBM) determined via Dual X‐Ray Absorptiometry. Observations of interest included total TT increased by 256±179ng/dl (64%) at Day 15 and 227±152 (57%) at Day 31 for the 4/day dose and 127±63 (20%) at Day 15 and 83±148 (13%) at Day 31 for the 6/day dose. Free TT increased by 144 pg/dl (166%) for the 2/day dose (in the 1 subject that had baseline free TT data) and 65±44 (83%) for the 4/day with no change for the 6/day at Day 31. Estradiol showed an inverse dose‐response relationship (2/day increase, 4/day no change, 6/day decrease) and LH increased more for product than placebo. LBM increased by about 0.5 kg for the 4/and 6/day (and placebo) and decreased by about 0.5 kg for the 2/day dose. Hemoglobin, hematocrit, total cholesterol, HDL and LDL decreased with the 6/day dose. In order to assess the magnitude and duration of these efficacy and safety changes, a longer study with a larger sample size is needed. This study was funded by Gaspari Nutrition, Inc.