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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Body Composition; Muscle Strength; Muscle Health
• Intervention / Treatment: Dietary supplement: Dietary Supplement - Placebo; Dietary supplement: Geranylgeraniol (150 mg); Dietary supplement: Geranylgeraniol (300 mg)

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony M Hagele, MS; Phone Number: 6369494785; Email: ahagele@lindenwood.edu
• Study Contact Backup: Name: Joesi M Morey, MS; Phone Number: 6168266008; Email: jmorey@lindenwood.edu

Study Locations

• United States
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Recruiting
      • Lindenwood University Exercise and Performance Nutrition Laboratory
      • Contact: Anthony M Hagele, MS; Phone Number: 636-949-4785; Email: ahagele@lindenwood.edu
      • Contact: Joesi M Morey, MS; Email: jmorey@lindenwood.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator; Participants 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 supplement: Dietary Supplement - Placebo; Participants 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.
Active Comparator: 150 mg Geranylgeraniol; 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 supplement: Geranylgeraniol (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.
Active Comparator: 300 mg Geranylgeraniol; 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.	Dietary supplement: Geranylgeraniol (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg Press One-Repetition Maximum (1RM)	Maximal lower-body strength will be assessed as leg press one-repetition maximum (1RM), defined as the greatest load that can be lifted for one complete repetition using proper technique.	Change from baseline (Week 0) to Week 8
Bench Press One-Repetition Maximum (1RM)	Maximal upper-body strength will be assessed as bench press one-repetition maximum (1RM), defined as the greatest load that can be lifted for one complete repetition using proper technique.	Change from baseline (Week 0) to Week 8
Fat-Free Mass	Fat-free mass will be assessed using a four-compartment body composition model derived from dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy (BIS).	Change from baseline (Week 0) to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg Press Muscular Endurance	Lower-body muscular endurance will be assessed as the number of repetitions completed to failure on the leg press using a load corresponding to 80% of the participant's baseline leg press 1RM.	Change from baseline (Week 0) to Week 8
Bench Press Muscular Endurance	Upper-body muscular endurance will be assessed as the number of repetitions completed to failure on the bench press using a load corresponding to 80% of the participant's baseline bench press 1RM.	Change from baseline (Week 0) to Week 8
Peak Oxygen Consumption (VO2peak)	Aerobic capacity will be assessed as peak oxygen consumption (VO2peak) during a graded treadmill exercise test.	Change from baseline (Week 0) to Week 8
Fat Mass	Fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy (BIS).	Change from baseline (Week 0) to Week 8
Percent Body Fat	Percent body fat will be assessed using dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy (BIS).	Change from baseline (Week 0) to Week 8
Total Body Water	Total body water will be assessed using bioelectrical impedance spectroscopy (BIS).	Change from baseline (Week 0) to Week 8
Intracellular Water	Intracellular water will be assessed using bioelectrical impedance spectroscopy (BIS).	Change from baseline (Week 0) to Week 8
Extracellular Water	Extracellular water will be assessed using bioelectrical impedance spectroscopy (BIS).	Change from baseline (Week 0) to Week 8
Plasma Coenzyme Q10 Concentration	Plasma coenzyme Q10 concentration will be assessed from venous blood samples.	Change from baseline (Week 0) to Week 8
Serum Testosterone Concentration	Serum testosterone concentration will be assessed from venous blood samples.	Change from baseline (Week 0) to Week 8
Serum Estrogen Concentration	Serum estrogen concentration will be assessed from venous blood samples.	Change from baseline (Week 0) to Week 8
Serum Progesterone Concentration	Serum progesterone concentration will be assessed from venous blood samples.	Change from baseline (Week 0) to Week 8
Profile of Mood States (POMS) Score	Mood state will be assessed using the Profile of Mood States (POMS) questionnaire.	Change from baseline (Week 0) to Week 8
RAND SF-36 Score	Health-related quality of life will be assessed using the RAND SF-36 questionnaire.	Change from baseline (Week 0) to Week 8
Fecal Metabolomic Profile	Fecal metabolomic outcomes will be assessed from self-collected stool samples.	Change from baseline (Week 0) to Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Heart Rate	Resting heart rate will be assessed under standardized resting conditions.	Change from baseline (Week 0) to Week 8
Resting Blood Pressure	Resting blood pressure will be assessed under standardized resting conditions.	Change from baseline (Week 0) to Week 8

Collaborators and Investigators

• Sponsor: Lindenwood University
• Investigators: Principal Investigator: Chad M Kerksick, PhD, Lindenwood University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: geranylgeraniol
• Other Study ID Numbers: IRB-25-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No