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

NCT ID: NCT06747624

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-10-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Geranylgeraniol 300 mg

Group Type: EXPERIMENTAL

Geranylgeraniol 300 mg

Intervention Type: DIETARY_SUPPLEMENT

300 mg of trans-geranylgeraniol (GG)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

300 mg medium chain triglycerides

Interventions

Geranylgeraniol 300 mg

300 mg of trans-geranylgeraniol (GG)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

300 mg medium chain triglycerides

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 or other 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 and baseline testing at the start of the crossover (at 10 weeks)

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 the study

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 blockers and 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 6 months

17. Failure to submit statement of consent

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Designs for Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Michael Jurgelewicz

Director, Product Development, Research, and Clinical Support

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Designs for Health, Inc.

Palm Coast, Florida, United States

Countries

United States

Other Identifiers

AR - 30040

Identifier Type: -

Identifier Source: org_study_id