Carbohydrate Availability and microRNA Expression
Influence of Carbohydrate Availability on Skeletal Muscle and Circulating microRNA Expression
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2018
CompletedResults Posted
Study results publicly available
September 2, 2021
CompletedSeptember 2, 2021
August 1, 2021
9 months
July 19, 2017
October 19, 2020
August 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fold Change in microRNA Expression From Baseline
Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.
24 hours
Secondary Outcomes (1)
Exogenous Carbohydrate Oxidation
80 minutes
Study Arms (2)
Adequate Carbohydrate
OTHERCarbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d
Low Carbohydrate
OTHERNon-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d
Interventions
During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion
During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage. For the day participants will consume a diet of 1.2 g/kg/d carbohydrate following glycogen depletion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USARIEM
Natick, Massachusetts, 01760, United States
Results Point of Contact
- Title
- Dr. Lee Margolis
- Organization
- USARIEM
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2017
First Posted
August 15, 2017
Study Start
August 1, 2017
Primary Completion
May 3, 2018
Study Completion
May 3, 2018
Last Updated
September 2, 2021
Results First Posted
September 2, 2021
Record last verified: 2021-08