Body Composition, Muscle Health, Muscle Strength
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTDietary 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.
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.
Sponsors
Lindenwood University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study will employ a double-blind design in which participants, investigators, and study personnel involved in data collection and outcome assessment are blinded to group assignment. Supplements will be prepared in identical form and appearance and coded by an independent party not involved in data collection or analysis. Group assignments will remain concealed until completion of data collection and primary analyses.
Intervention model description
Participants will be randomized to one of three parallel groups to receive either placebo, 150 mg geranylgeraniol (GG), or 300 mg geranylgeraniol (GG) daily for 8 weeks. Randomization will be stratified by sex, age, and baseline fat-free mass. All groups will follow the same testing schedule and procedures throughout the study period.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Press One-Repetition Maximum (1RM) | Change from baseline (Week 0) to Week 8 | 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. |
| Bench Press One-Repetition Maximum (1RM) | Change from baseline (Week 0) to Week 8 | 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. |
| Fat-Free Mass | Change from baseline (Week 0) to Week 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leg Press Muscular Endurance | Change from baseline (Week 0) to Week 8 | 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. |
| Bench Press Muscular Endurance | Change from baseline (Week 0) to Week 8 | 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. |
| Peak Oxygen Consumption (VO2peak) | Change from baseline (Week 0) to Week 8 | Aerobic capacity will be assessed as peak oxygen consumption (VO2peak) during a graded treadmill exercise test. |
| Fat Mass | Change from baseline (Week 0) to Week 8 | Fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy (BIS). |
| Percent Body Fat | Change from baseline (Week 0) to Week 8 | Percent body fat will be assessed using dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy (BIS). |
| Total Body Water | Change from baseline (Week 0) to Week 8 | Total body water will be assessed using bioelectrical impedance spectroscopy (BIS). |
| Intracellular Water | Change from baseline (Week 0) to Week 8 | Intracellular water will be assessed using bioelectrical impedance spectroscopy (BIS). |
| Extracellular Water | Change from baseline (Week 0) to Week 8 | Extracellular water will be assessed using bioelectrical impedance spectroscopy (BIS). |
| Plasma Coenzyme Q10 Concentration | Change from baseline (Week 0) to Week 8 | Plasma coenzyme Q10 concentration will be assessed from venous blood samples. |
| Serum Testosterone Concentration | Change from baseline (Week 0) to Week 8 | Serum testosterone concentration will be assessed from venous blood samples. |
| Serum Estrogen Concentration | Change from baseline (Week 0) to Week 8 | Serum estrogen concentration will be assessed from venous blood samples. |
| Serum Progesterone Concentration | Change from baseline (Week 0) to Week 8 | Serum progesterone concentration will be assessed from venous blood samples. |
| Profile of Mood States (POMS) Score | Change from baseline (Week 0) to Week 8 | Mood state will be assessed using the Profile of Mood States (POMS) questionnaire. |
| RAND SF-36 Score | Change from baseline (Week 0) to Week 8 | Health-related quality of life will be assessed using the RAND SF-36 questionnaire. |
| Fecal Metabolomic Profile | Change from baseline (Week 0) to Week 8 | Fecal metabolomic outcomes will be assessed from self-collected stool samples. |
Countries
United States
Contacts
CONTACTAnthony M Hagele, MS
CONTACTJoesi M Morey, MS
PRINCIPAL_INVESTIGATORChad M Kerksick, PhD
Lindenwood University
Outcome results
None listed