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RecruitingNCT07502924

Dose-Response Impact of Geranylgeraniol (GG) Supplementation on Muscle Health

Dose-Response Impact of Geranylgeraniol (GG) Supplementation on Muscular Strength, Body Composition, Sex Steroid Hormones and CoQ10 Levels in Healthy Men and Women

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Lindenwood University · Academic / Other
Sex
All
Age
30 Years – 60 Years
Healthy volunteers
Accepted

Summary

This study will evaluate the effects of daily geranylgeraniol (GG) supplementation on muscular strength, body composition, and aerobic capacity in healthy, physically active men and women. Approximately 60 participants aged 30-60 years will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group trial lasting 8 weeks. Participants will be assigned to receive either placebo, 150 mg GG, or 300 mg GG daily. Outcome measures will be assessed at baseline, week 4, and week 8 and include maximal strength (1RM bench press and leg press), fat-free mass, muscular endurance, aerobic capacity (VO2peak), and circulating biomarkers related to metabolism and health.

Detailed description

This study is a randomized, double-blind, placebo-controlled, parallel-group trial designed to examine the dose-response effects of geranylgeraniol (GG) supplementation on muscular strength, body composition, aerobic capacity, and physiological biomarkers in healthy, physically active adults. Approximately 60 men and women aged 30-60 years will be recruited and randomized, stratified by sex, age, and baseline fat-free mass, to receive one of three interventions: placebo, 150 mg GG, or 300 mg GG daily for 8 weeks. All participants and study personnel will remain blinded to group allocation throughout the study. Participants will complete a screening visit followed by testing visits at baseline (week 0), week 4, and week 8. Assessments will include maximal strength testing (1RM bench press and leg press), muscular endurance (repetitions to failure at a fixed percentage of 1RM), aerobic capacity (VO2peak via graded treadmill test), and body composition using a four-compartment model derived from dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy. Venous blood samples will be collected to assess coenzyme Q10, sex steroid hormones, inflammatory markers, and clinical safety parameters including complete blood count, comprehensive metabolic panel, and lipid profile. Additional outcomes include mood and quality of life assessed via validated questionnaires (POMS and SF-36), dietary intake via 4-day food logs, and fecal samples for metabolomic analysis. The primary endpoints are changes in maximal strength (1RM leg press and bench press) and fat-free mass from baseline to week 8. Secondary endpoints include changes in muscular endurance, aerobic capacity, body composition variables, biochemical markers, and patient-reported outcomes. Safety will be monitored throughout the study via clinical labs and adverse event reporting.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDietary Supplement - PlaceboParticipants will ingest a placebo consisting of olive oil daily for 8 weeks. The supplement will be consumed with approximately 8 ounces of water at a consistent time each day.
DIETARY_SUPPLEMENTGeranylgeraniol (150 mg)Participants will ingest 150 mg of geranylgeraniol (GG) daily for 8 weeks. The supplement will be consumed with approximately 8 ounces of water at a consistent time each day.
DIETARY_SUPPLEMENTGeranylgeraniol (300 mg)Participants will ingest 300 mg of geranylgeraniol (GG) daily for 8 weeks. The supplement will be consumed with approximately 8 ounces of water at a consistent time each day.

Timeline

Start date
2025-03-03
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2026-03-31
Last updated
2026-03-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07502924. Inclusion in this directory is not an endorsement.