Geranylgeraniol doses to improve muscle strength, body composition, and aerobic fitness
Dose-Response Impact of Geranylgeraniol (GG) Supplementation on Muscular Strength, Body Composition, Sex Steroid Hormones and CoQ10 Levels in Healthy Men and Women
This project will test whether taking daily geranylgeraniol (150 mg or 300 mg) improves muscle strength, lean body mass, and aerobic fitness in healthy, physically active adults aged 30–60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Lindenwood University Academic / other |
| Locations | 1 site (Saint Charles, Missouri) |
| Trial ID | NCT07502924 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, parallel-group trial enrolling about 60 healthy, physically active men and women ages 30–60. Participants are randomized (stratified by sex, age, and baseline fat-free mass) to receive placebo, 150 mg GG, or 300 mg GG daily for eight weeks. Outcomes are measured at baseline, week 4, and week 8 and include 1RM bench and leg press, muscular endurance, VO2peak, four-compartment body composition, blood biomarkers (CoQ10, hormones, inflammatory markers, safety labs), mood and quality-of-life questionnaires, dietary logs, and fecal metabolomics. All participants and study staff are blinded to assignment throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are physically active men and women aged 30–60 with BMI 18.5–29.9 kg/m2 who can attend on-site testing at Lindenwood University and agree to avoid specified supplements and maintain usual diet and exercise habits.
Not a fit: People outside the 30–60 age range, those with BMI <18.5 or ≥30 kg/m2, or individuals with cardiovascular, kidney disease, diabetes, or who regularly take excluded supplements are unlikely to benefit or qualify for the protocol.
Why it matters
Potential benefit: If effective, GG supplementation could increase muscle strength and lean mass and modestly improve aerobic fitness in healthy, active adults while informing dietary supplement recommendations.
How similar studies have performed: Related preclinical work and limited human data on prenyl compounds and CoQ10 precursors show mixed and preliminary results, and a controlled dose-response trial of GG in healthy adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 30 and 60 years old. * Body mass index values will range from \>18.5 and \<29.9 kg/m2 * Subject agrees to maintain their existing dietary patterns throughout the study period. * Subject agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours prior to each test day. * Is physically active, defined as at least 30 min of moderate exercise on at least 4 days a week. * Avoid consumption of pomegranate juice and avoid consumption of CoQ10, vitamin B3 and its precursors, L-carnitine, MK-4 * Subject is willing and able to comply with the study protocol. * Subject has given voluntary, written, informed consent to participate in the study. Exclusion Criteria: * BMI \<18.5 or \> 29.9 kg/m2 * Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease, kidney disease, renal failure, or has dialysis performed on regular intervals, Type I or Type II diabetes (determined as fasting blood glucose \> 126 mg/dL), thyroid disease, liver disease or some form of clinically diagnosed hepatic impairment, immune disorder (i.e., HIV/AIDS), or neurological condition or disease. * Diagnosed with any affective disorder or other psychiatric disorder that required hospitalization in the prior year. * History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). * Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) * Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism * Has donated blood in past 60 days * Diagnosed with or being treated for any endocrinological disorder and/or taking hormone boosting supplements (e.g. herbs) or hormone replacement therapy (prescribed/doctor ordered or not) * Had CoQ10 supplement in past 30 days. Had steroid medication one month before starting the study * Currently prescribed for the first time a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) and/or a hypertension medication (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, - Vasodilators, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months * Current smoker (average of \> 1 pack per week within the past 3 months) or has quit within the past six months. This includes all forms of nicotine * Intake of any drugs (prescribed or over the counter) or dietary supplements that are known or are purported to impact energy expenditure or weight loss (caffeine doses \<300 mg/day is permissible) * Women with a history of hormone-related conditions such as endometriosis, fibroids, polycystic ovary syndrome * Women who are pregnant, planning to become pregnant, or lactating currently or within the past six months * Have a known sensitivity or allergy to any of the study products * History of alcohol or substance abuse in the 12 months prior to screening * Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol * Has participated in other clinical trials focused on physical and muscle performance within the last year * They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study * Individuals who regularly compete as part of sanctioned athletic activities or those individuals who regularly train more than 360 minutes of exercise per week * Recent history (\<3 months) of exercise training or weight loss (\> 5%) * Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
Where this trial is running
Saint Charles, Missouri
- Lindenwood University Exercise and Performance Nutrition Laboratory — Saint Charles, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Chad M Kerksick, PhD — Lindenwood University
- Study coordinator: Anthony M Hagele, MS
- Email: ahagele@lindenwood.edu
- Phone: 6369494785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.