Glycogen DepletionNCT03250234
Carbohydrate Availability and microRNA Expression
A study testing Adequate Carbohydrate and Low Carbohydrate in people with Glycogen Depletion, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycogen Depletion
- What is being tested?
- Adequate Carbohydrate and Low Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 3 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Musculoskeletal injuries that compromise the ability to exercise
- Blood donation within 8 weeks of beginning the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Carbohydrate Availability on Skeletal Muscle and Circulating microRNA Expression
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.
Read the 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.
- Conditions
- Glycogen Depletion
- Being tested
- Adequate Carbohydrate, Low Carbohydrate
- Keywords
- microRNA, carbohydrate oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adequate CarbohydrateOther
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
Low CarbohydrateOther
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
| Study group | Role | What they receive |
|---|---|---|
| Adequate Carbohydrate | Other | Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d Receives: Other: Adequate Carbohydrate |
| Low Carbohydrate | Other | Non-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d Receives: Other: Low Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 80 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Aug 2017
- Primary completion3 May 2018
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glycogen DepletionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250234
- Sponsor's protocol ID
- 17-17H
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2017
- Last updated
- 2 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Carbohydrate Availability on Skeletal Muscle and Circulating microRNA Expression
- ClinicalTrials.gov ID
- NCT03250234
- Acronym / sponsor ID
- 17-17H
- Conditions
- Glycogen Depletion
- Keywords
- microRNA, carbohydrate oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 2 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adequate Carbohydrate | Other | Other: Adequate CarbohydrateCarbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d |
| Low Carbohydrate | Other | Other: Low CarbohydrateNon-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adequate CarbohydrateDuring 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 | Other | Adequate Carbohydrate |
| Low CarbohydrateDuring 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 | Other | Low Carbohydrate |
Primary outcome
Fold Change in microRNA Expression From Baseline
Time frame: 24 hours
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.
1 secondary outcome
Exogenous Carbohydrate Oxidation
Time frame: 80 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Glycogen Depletion
Active, not recruiting
Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
Ketogenic Diet, Control Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adequate Carbohydrate and Low Carbohydrate in people with Glycogen Depletion, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Change in microRNA Expression From Baseline (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.