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

NCT06747624 | Completed

• 1 other identifier: AR - 30040
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Health; Wellness

Keywords

Geranylgeraniol; GG

Outcome Measures

Primary Outcomes (2)

• Serum Total Testosterone (LC/MS-MS)

  Can aid in the diagnosis of androgen dysfunction in men and women and is more specific method of measuring testosterone concentrations. Units in ng/ml.

  Baseline, 8 weeks, 10 weeks, and 18 weeks

• Serum Free Testosterone (Direct)

  The concentration of unbound testosterone in serum. The majority of serum total testosterone is associated with sex hormone binding globulin (SHBG) and this fraction is tightly bound and bio-logically unavailable to its target tissues. The remaining bioavailable testosterone is mostly bound to albumin, with only a small fraction circulating in the free form. Free testosterone is the form of testosterone that can diffuse into the tissues and act on receptors and is considered the active fraction. Free testosterone assessment is recommended as a primary or secondary measure of androgen activity in men and women. Units in pg/ml.

  Baseline, 8 weeks, 10 weeks, and 18 weeks

Secondary Outcomes (4)

• Serum Sex Hormone Binding Globulin (SHBG)

  Baseline, 8 weeks, 10 weeks, and 18 weeks

• Coenzyme Q10 (CoQ10)

  Baseline, 8 weeks, 10 weeks, and 18 weeks

• SF-12- Health Survey

  Baseline, 8 weeks, 10 weeks, and 18 weeks

• PROMIS- Sexual Health and Satisfaction

  Baseline, 8 weeks, 10 weeks, and 18 weeks

Study Arms (2)

Geranylgeraniol 300 mg

EXPERIMENTAL

Dietary Supplement: Geranylgeraniol 300 mg

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Geranylgeraniol 300 mg DIETARY_SUPPLEMENT

300 mg of trans-geranylgeraniol (GG)

Geranylgeraniol 300 mg

Placebo DIETARY_SUPPLEMENT

300 mg medium chain triglycerides

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 40 to 65 years of age.
• 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.
• Ability to read and speak English
• Subject's agreement to voluntarily participate in the study
• Negative pregnancy test confirmed with serum HCG on initial baseline testing and baseline testing at the start of the crossover (at 10 weeks)

You may not qualify if:

• Males and females under 40 or over 65 years of age
• Previous (in the past 60 days) or current hormone replacement therapy
• Males and females with free testosterone levels over normal range
• History of hysterectomy, oophorectomy, or orchiectomy
• Current biotin supplementation \>3 mg per day one week prior to the start of the study
• Current or history of smoking
• CoQ10/Ubiquinol supplementation within the past 2 weeks
• Current use of hormone boosting supplements (i.e. fenugreek, shilajit, tongkat ali, ashwagandha) within the past 4 weeks
• Current or previous use of medication - NSAIDS, statins, blood thinners, H2 blockers and PPI or blood sugar-lowering agents.
• Diabetes
• Cancer
• Hemophilia
• Disorders of heart, kidney, lung or liver function
• Infectious diseases
• Alcohol or drug abuse (\>7 drinks per week for men and women)

Sponsors & Collaborators

• Designs for Health: lead

Study Sites (1)

Designs for Health, Inc.

Palm Coast, Florida, 32164, United States

Location

MeSH Terms

Interventions

geranylgeraniol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Product Development, Research, and Clinical Support

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 30, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)