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Carbohydrate Availability and microRNA Expression

Influence of Carbohydrate Availability on Skeletal Muscle and Circulating microRNA Expression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03250234
Enrollment
12
Registered
2017-08-15
Start date
2017-08-01
Completion date
2018-05-03
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycogen Depletion

Keywords

microRNA, carbohydrate oxidation

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.

Detailed description

Twelve, normal weight, healthy, physically active men and women will complete a glycogen depletion protocol, cycling at various intensities until failure. Participants will then consume a carbohydrate (CHO: 1 g/kg/hr) or an energy free control (CON) beverage matched for taste and color during the first 3-hr post glycogen depletion. For the remainder of the day participants will consume a diet designed to adequately (6.0 g CHO/kg/d) or inadequately (1.2 g CHO/kg/d) replenish glycogen stores. The following day participants will to complete 80-min of steady-state (\ 60% VO2peak) cycle ergometry consuming carbohydrate at a rate of 1.8 g/min enriched with a stable isotope of carbon to determine exogenous carbohydrate efficiency when glycogen stores are low or adequate at the onset of exercise. Following a minimum 7-d washout period volunteers will return to the laboratory to complete the second arm of the investigation. To ensure glycogen stores are similar between volunteers on testing day, 48-hrs prior to testing all volunteers will complete a glycogen depletion protocol and then consume a diet providing 6.0 g/kg/d carbohydrate to replenish glycogen stores.

Interventions

OTHERAdequate Carbohydrate

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

Sponsors

United States Army Research Institute of Environmental Medicine
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fold Change in microRNA Expression From Baseline24 hoursDetermine 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.

Secondary

MeasureTime frameDescription
Exogenous Carbohydrate Oxidation80 minutesDetermine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.

Countries

United States

Participant flow

Pre-assignment details

This was a cross over design. 12 participants enrolled and completed both study arms.

Participants by arm

ArmCount
Adequate Carbohydrate First, Then Low Carbohydrate
Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d Adequate Carbohydrate: 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
6
Low Carbohydrate First, Then Adequate Carbohydrate
Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d Low Carbohydrate: 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 1.5 g/kg/d carbohydrate following glycogen depletion
6
Total12

Baseline characteristics

CharacteristicLow Carbohydrate First, Then Adequate CarbohydrateTotalAdequate Carbohydrate First, Then Low Carbohydrate
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants12 Participants6 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
6 Participants12 Participants6 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
6 Participants12 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
1 / 121 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

Primary

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.

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Adequate CarbohydrateFold Change in microRNA Expression From Baseline0.73 fold changeStandard Deviation 0.2
Low CarbohydrateFold Change in microRNA Expression From Baseline1.36 fold changeStandard Deviation 1.35
Secondary

Exogenous Carbohydrate Oxidation

Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.

Time frame: 80 minutes

ArmMeasureValue (MEAN)Dispersion
Adequate CarbohydrateExogenous Carbohydrate Oxidation.87 g/minStandard Deviation 0.16
Low CarbohydrateExogenous Carbohydrate Oxidation.84 g/minStandard Deviation 0.14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026