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New treatment option for Muscle Health
Official title Dose-Response Impact of Geranylgeraniol (GG) Supplementation on Muscle Health
ClinicalTrials.gov ID: NCT07502924
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- BMI \ 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...
- 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...
- Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism
See the full eligibility criteria
Who can join
- 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.
What rules you out
- BMI \ 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...
- 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...
- 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...
- 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 (\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Saint Charles, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Charles, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.