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

Last updated: May 12, 2025
Sponsor: Designs for Health
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Geranylgeraniol 300 mg

Clinical Study ID

NCT06747624
AR - 30040
  • Ages 40-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females between 40 to 65 years of age.

  2. Individuals with no significant history of inflammatory bowel disease (i.e.ulcerative colitis, Crohn's, Celiac, etc.), ulcers, liver and/or kidney disease orother any acute or chronic dis-ease.

  3. Ability to read and speak English

  4. Subject's agreement to voluntarily participate in the study

  5. Negative pregnancy test confirmed with serum HCG on initial baseline testing andbaseline testing at the start of the crossover (at 10 weeks)

Exclusion

Exclusion Criteria:

  1. Males and females under 40 or over 65 years of age

  2. Previous (in the past 60 days) or current hormone replacement therapy

  3. Males and females with free testosterone levels over normal range

  4. History of hysterectomy, oophorectomy, or orchiectomy

  5. Current biotin supplementation >3 mg per day one week prior to the start of thestudy

  6. Current or history of smoking

  7. CoQ10/Ubiquinol supplementation within the past 2 weeks

  8. Current use of hormone boosting supplements (i.e. fenugreek, shilajit, tongkat ali,ashwagandha) within the past 4 weeks

  9. Current or previous use of medication - NSAIDS, statins, blood thinners, H2 blockersand PPI or blood sugar-lowering agents.

  10. Diabetes

  11. Cancer

  12. Hemophilia

  13. Disorders of heart, kidney, lung or liver function

  14. Infectious diseases

  15. Alcohol or drug abuse (>7 drinks per week for men and women)

  16. Pregnancy, lactation, or individuals planning to become pregnant in the next 6months

  17. Failure to submit statement of consent

  18. Participant in a clinical trial in the previous 30 days.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
January 30, 2025
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Designs for Health, Inc.

    Palm Coast, Florida 32164
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.