Trial Outcomes & Findings for Carbohydrate Availability and microRNA Expression (NCT NCT03250234)

NCT ID: NCT03250234

Last Updated: 2021-09-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2021-09-02

Participant Flow

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

Participant milestones

Measure	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	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
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This was a crossover study

Baseline characteristics by cohort

Measure	Adequate Carbohydrate First, Then Low Carbohydrate n=6 Participants 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	Low Carbohydrate First, Then Adequate Carbohydrate n=6 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 beverage. For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants • This was a crossover study	0 Participants n=6 Participants • This was a crossover study	0 Participants n=12 Participants • This was a crossover study
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants • This was a crossover study	6 Participants n=6 Participants • This was a crossover study	12 Participants n=12 Participants • This was a crossover study
Age, Categorical >=65 years	0 Participants n=6 Participants • This was a crossover study	0 Participants n=6 Participants • This was a crossover study	0 Participants n=12 Participants • This was a crossover study
Sex: Female, Male Female	0 Participants n=6 Participants • This was a crossover study	0 Participants n=6 Participants • This was a crossover study	0 Participants n=12 Participants • This was a crossover study
Sex: Female, Male Male	6 Participants n=6 Participants • This was a crossover study	6 Participants n=6 Participants • This was a crossover study	12 Participants n=12 Participants • This was a crossover study
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 Participants n=6 Participants • This was a crossover study	6 Participants n=6 Participants • This was a crossover study	12 Participants n=12 Participants • This was a crossover study

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Adequate Carbohydrate n=12 Participants 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	Low Carbohydrate n=12 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
Fold Change in microRNA Expression From Baseline	0.73 fold change Standard Deviation .2	1.36 fold change Standard Deviation 1.35

SECONDARY outcome

Timeframe: 80 minutes

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.

Outcome measures

Measure	Adequate Carbohydrate n=12 Participants 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	Low Carbohydrate n=12 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
Exogenous Carbohydrate Oxidation	.87 g/min Standard Deviation .16	.84 g/min Standard Deviation .14

Adverse Events

Adequate Carbohydrate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Low Carbohydrate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adequate Carbohydrate n=12 participants at risk 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	Low Carbohydrate n=12 participants at risk 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
Musculoskeletal and connective tissue disorders Hamstring Cramping	8.3% 1/12 • Number of events 1 • 3 weeks Hamstring cramping	8.3% 1/12 • Number of events 1 • 3 weeks Hamstring cramping

Additional Information

Dr. Lee Margolis

USARIEM

Phone: 508-206-2335

Email: lee.m.margolis.civ@mail.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place