NCT03250234

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

July 19, 2017

Results QC Date

October 19, 2020

Last Update Submit

August 6, 2021

Conditions

Keywords

microRNA, carbohydrate oxidation

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

OTHER

Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d

Other: Adequate Carbohydrate

Low Carbohydrate

OTHER

Non-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d

Other: Low Carbohydrate

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

Adequate 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 1.2 g/kg/d carbohydrate following glycogen depletion

Low Carbohydrate

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

Locations