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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adequate Carbohydrate | Other | Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d |
|
| Low Carbohydrate | Other | Non-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adequate Carbohydrate | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USARIEM | Natick | Massachusetts | 01760 | United States |
This was a cross over design. 12 participants enrolled and completed both study arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adequate Carbohydrate First, Then Low Carbohydrate | Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d first, then Low carbohydrate diet 1.5 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 7 day washout Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion |
| FG001 | Low Carbohydrate First, Then Adequate Carbohydrate | Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d first, then adequate carbohydrate diet 6.0 g/kg/d Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage. For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion 7 day washout 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This was a crossover study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | fold change | 24 hours |
|
3 weeks
Hamstring cramping
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adequate 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hamstring Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Margolis | USARIEM | 508-206-2335 | lee.m.margolis.civ@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2019 | Sep 3, 2020 | Prot_SAP_000.pdf |
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| Low Carbohydrate | Other | 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 |
|
| 80 minutes |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | This was a crossover study | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | This was a crossover study | Count of Participants | Participants |
|
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 (0 kcal) beverage. For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion |
|
|
| 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. | Posted | Mean | Standard Deviation | g/min | 80 minutes |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Low 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 (0 kcal) beverage. For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion | 0 | 12 | 0 | 12 | 1 | 12 |
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