Dose-Response Impact of Geranylgeraniol (GG) Supplementation on Muscle Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorLindenwood University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary Supplement - Placebo
Dietary supplementParticipants 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.
Geranylgeraniol (150 mg)
Dietary supplementParticipants 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.
Geranylgeraniol (300 mg)
Dietary supplementParticipants 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.
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: Placebo ComparatorPlacebo comparator 1 intervention
Group B: 150 mg GeranylgeraniolActive comparator 1 intervention
Group C: 300 mg GeranylgeraniolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline (Week 0) to Week 82
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.
Time frame
Change from baseline (Week 0) to Week 83
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).
Time frame
Change from baseline (Week 0) to Week 8Secondary outcomes
1
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.
Time frame
Change from baseline (Week 0) to Week 82
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.
Time frame
Change from baseline (Week 0) to Week 83
Peak Oxygen Consumption (VO2peak)
Aerobic capacity will be assessed as peak oxygen consumption (VO2peak) during a graded treadmill exercise test.
Time frame
Change from baseline (Week 0) to Week 84
Fat Mass
Fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance spectroscopy (BIS).
Time frame
Change from baseline (Week 0) to Week 8Other outcomes
1
Resting Heart Rate
Resting heart rate will be assessed under standardized resting conditions.
Time frame
Change from baseline (Week 0) to Week 82
Resting Blood Pressure
Resting blood pressure will be assessed under standardized resting conditions.
Time frame
Change from baseline (Week 0) to Week 8Sponsors and contacts
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Source ClinicalTrials.gov