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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geranylgeraniol 300 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geranylgeraniol 300 mg | Dietary Supplement | 300 mg of trans-geranylgeraniol (GG) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Designs for Health, Inc. | Palm Coast | Florida | 32164 | United States |
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| Placebo |
| Dietary Supplement |
300 mg medium chain triglycerides |
|
| 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. | 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. | 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. | Baseline, 8 weeks, 10 weeks, and 18 weeks |
| ID | Term |
|---|---|
| C017338 | geranylgeraniol |
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