NCT06747624

A Crossover Clinical Trial Investigating the Effects of Geranylgeraniol (GG) Supplementation on Testosterone Levels in Healthy Men and Women Over an 18-week Period

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Designs for Health · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to investigate the effects of geranylgeraniol (GG) supplementation on testosterone levels in middle-aged (40 to 65 years) healthy men and women. The research team hypothesizes that geranylgeraniol (GG) supplementation will enhance testosterone levels and improve self-reported health outcomes in a healthy population.

Detailed description

The proposed study is an 18-week crossover, placebo-controlled pilot study of GG supplementation or placebo. All study outcomes will be measured at baseline (the beginning of the first week) and at the conclusion of the first 8-week period. This will be followed by a 2-week washout period; study procedures will be repeated with the second intervention for an additional 8 weeks. Outcomes will be assessed at the beginning of this period, and the end, in the same manner as for the first 8-week block. All participants will receive a placebo (300 mg medium chain triglycerides/daily) or gernaylgeraniol supplementation (300 mg GG/daily). Subjects will be required to fast for 8 hours with no alcohol consumption before their blood draw. Baseline blood samples will be drawn before administering one of two treatments with subsequent blood samples to be drawn in the morning (between 7 am and 8 am) at 8, 10, and 18 weeks. Each participant will take the assigned intervention daily with breakfast for the following 8 weeks. After a 14-day washout period, this process will be repeated for the remaining treatment. Self-reported height and weight will be obtained to calculate body mass index (BMI). Questionnaires on overall health (SF-36) and sexual health \[PROMIS Sexual Function and Satisfaction (SexFS) v2.0 Brief Profile (Male/Female)\] will be assessed at baseline, 8, 10, and 18 weeks. All laboratory testing will occur at a LabCorp patient service center. The serum samples will be analyzed for Free and Total Testosterone using liquid chromatography with tandem mass spectrometry (LC-MS-MS). LabCorp test code: 070195; Serum Sex Hormone-Binding Globulin (SHBG) will be analyzed using Electrochemiluminescence immunoassay (ECLIA). LabCorp test code: 082016. Coenzyme Q10, Total (CoQ10). LabCorp test code: 120251.

Conditions

• Wellness
• Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Geranylgeraniol 300 mg	300 mg of trans-geranylgeraniol (GG)
DIETARY_SUPPLEMENT	Placebo	300 mg medium chain triglycerides

Timeline

• Start date: 2025-01-30
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2024-12-24
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States