WellnessNCT06747624
A Crossover Clinical Trial Investigating the Effects of Geranylgeraniol (GG) Supplementation on Testosterone Levels in Healthy Men and Women Over an 18-week Period
A study testing Geranylgeraniol 300 mg in people with Wellness and Health, run by Designs for Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Geranylgeraniol 300 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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)
- Pregnancy, lactation, or individuals planning to become pregnant in the next 6 months
- Failure to submit statement of consent
- Participant in a clinical trial in the previous 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Geranylgeraniol 300 mg, Placebo
- Keywords
- Geranylgeraniol, GG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geranylgeraniol 300 mgDietary supplement
300 mg of trans-geranylgeraniol (GG)
PlaceboDietary supplement
300 mg medium chain triglycerides
| Study group | Role | What they receive |
|---|---|---|
| Geranylgeraniol 300 mg | Experimental | Not described Receives: Dietary Supplement: Geranylgeraniol 300 mg |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 8 weeks, 10 weeks, and 18 weeks
Secondary outcomes (4)
Serum Sex Hormone Binding Globulin (SHBG)
The blood transport protein for testosterone and estradiol. SHBG binds reversibly to sexual steroids and is an important indicator of an excessive/chronic androgenic action where androgen levels are normal, but where clinical symptoms would seem to indicate androgen in excess. SHBG is a useful supplementary parameter in the determination of androgen where a high concentration of free androgen (i.e., testosterone) is suspected. Reference ranges in men: 20-49 years: 16.5-55.9 nmol/L; >49 years: 19.3-76.4 nmol/L. Reference ranges in women: 20-49 years: 24.6-122.0 nmol/L; >49 years: 17.3-125.0 nmol/L.
Measured: Baseline, 8 weeks, 10 weeks, and 18 weeks
Coenzyme Q10 (CoQ10)
CoQ10 is endogenously synthesized via the mevalonate pathway and some is obtained in the diet from meat products. It is also a powerful lipid-soluble antioxidant protecting cell membranes and lipoproteins. Reference range: 0.37-2.20 µg/mL.
Measured: Baseline, 8 weeks, 10 weeks, and 18 weeks
SF-12- Health Survey
The SF-12 (Short Form Health Survey) is an indicator of overall health status across eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Measured: Baseline, 8 weeks, 10 weeks, and 18 weeks
PROMIS- Sexual Health and Satisfaction
Sexual health [PROMIS Sexual Function and Satisfaction (SexFS) v2.0 Brief Profile (Male) and (Female)]. The SexFS assesses interest in sexual activity. These are domains relevant to healthy individuals.
Measured: Baseline, 8 weeks, 10 weeks, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start30 Jan 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Designs for Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michael Jurgelewicz, Designs for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747624
- Sponsor's protocol ID
- AR - 30040
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Clinical Trial Investigating the Effects of Geranylgeraniol (GG) Supplementation on Testosterone Levels in Healthy Men and Women Over an 18-week Period
- ClinicalTrials.gov ID
- NCT06747624
- Acronym / sponsor ID
- AR - 30040
- Keywords
- Geranylgeraniol, GG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Designs for HealthIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geranylgeraniol 300 mg | Experimental | Dietary Supplement: Geranylgeraniol 300 mg |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geranylgeraniol 300 mg300 mg of trans-geranylgeraniol (GG) | Dietary supplement | Geranylgeraniol 300 mg |
| Placebo300 mg medium chain triglycerides | Dietary supplement | Placebo |
Primary outcome
Serum Total Testosterone (LC/MS-MS)
Time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks
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.
Serum Free Testosterone (Direct)
Time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks
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.
4 secondary outcomes
Serum Sex Hormone Binding Globulin (SHBG)
Time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks
Coenzyme Q10 (CoQ10)
Time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks
SF-12- Health Survey
Time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks
PROMIS- Sexual Health and Satisfaction
Time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geranylgeraniol 300 mg in people with Wellness and Health, run by Designs for Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Total Testosterone (LC/MS-MS) (time frame: Baseline, 8 weeks, 10 weeks, and 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.