N/A
N=12
Carbohydrate Availability and microRNA Expression
Glycogen Depletion
Bottom Line
View on ClinicalTrials.gov: NCT03250234 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Fold Change in microRNA Expression From Baseline — 0.73; 1.36 fold change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adequate Carbohydrate (Other); Low Carbohydrate (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- United States Army Research Institute of Environmental Medicine
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fold Change in microRNA Expression From Baseline |
0.73; 1.36 | — |
| SECONDARY Exogenous Carbohydrate Oxidation |
.87; .84 | — |
Summary
This investigation will examine the impact of skeletal muscle glycogen stores on skeletal muscle and circulating microRNA expression and exogenous carbohydrate oxidation.
Primary Objective Determine the influence of carbohydrate availability (e.g., glycogen depletion and repletion) on skeletal muscle microRNA expression, and if changes in circulating microRNA are reflective of changes in skeletal muscle microRNA.
Secondary Objective Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 - 39 years
- Weight stable (±5 lbs) for at least 2 months prior to the start of the study
- Body mass index (BMI) between 18.5-30 kg/m2
- Recreationally active based on assessment of physical activity history 2-4 days per week aerobic and/or resistance exercise
- Refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®, or any aspirin-containing product for 10 days before and at least 5 days AFTER each muscle biopsy. (*Tylenol® or acetaminophen is ok to use if needed for discomfort)
- Refrain from the use of alcohol and nicotine for the duration of the study
- Females must be on contraception (e.g., oral birth control, NuvaRing®, Depo Provera®, etc.)
- Supervisor approved leave status for federal civilian employees working within the US Army Natick Soldier Systems Center
Exclusion Criteria
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)
- Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
- Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
- Anemia (HCT < 38) and Sickle Cell Anemia/Trait
- Abnormal prothrombin time (PT)/ partial thromboplastin time (PTT) test or problems with blood clotting
- Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
- Musculoskeletal injuries that compromise the ability to exercise
- Blood donation within 8 weeks of beginning the study
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03250234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.