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Clinical Trials/NCT04371237
NCT04371237CompletedNot Applicable

Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy

PepsiCo Global R&D1 site in 1 country26 target enrollmentStarted: September 19, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Rate of glycogen resynthesis

Study Overview

Brief Summary

To determine if modalities designed to improve blood flow combined with post-exercise nutrient intake will improve replenishment of muscle glycogen better than nutrient intake alone. A secondary objective is to compare the effectiveness of heat therapy and intermittent pneumatic compression on glycogen replenishment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subjects will be male and female participants in good health
  • •18-35 years of age
  • •Currently performing cardiovascular or intermittent exercise at a moderate to high intensity at least 5 days per week for 60 minutes or longer per day.
  • •Understanding of the procedures to be undertaken as part of the study
  • •Willingness to participate in exercise testing and follow instructions provided by the experimenter
  • •Informed, voluntary, written consent to participate in the study

Exclusion Criteria

  • •History of deep vein thrombosis
  • •Obesity (BMI > 30 kg/m2)
  • •Hypertension (resting SBP > 140/90 mmHg)
  • •Pregnant, planning to become pregnant, or lactating
  • •Supplements containing antioxidants including vitamin C and E and N-acetyl cysteine
  • •Any medication
  • •Lactose intolerance
  • •Participation in another study within the previous 30 days or in a PepsiCo funded study within the past 6 months.

Arms & Interventions

Heat therapy

Experimental

Custom water-circulating garment on leg

Intervention: Glycogen-depleting exercise session (Other)

Intermittent pneumatic compression

Experimental

IPC sleeve device on leg

Intervention: Compression sleeve (Device)

Intermittent pneumatic compression

Experimental

IPC sleeve device on leg

Intervention: Glycogen-depleting exercise session (Other)

Intermittent pneumatic compression

Experimental

IPC sleeve device on leg

Intervention: Nutrient Intake (beverage) (Other)

Intermittent pneumatic compression

Experimental

IPC sleeve device on leg

Intervention: Skeletal muscle biopsy (Procedure)

Heat therapy

Experimental

Custom water-circulating garment on leg

Intervention: Heat therapy (Device)

Heat therapy

Experimental

Custom water-circulating garment on leg

Intervention: Nutrient Intake (beverage) (Other)

Heat therapy

Experimental

Custom water-circulating garment on leg

Intervention: Skeletal muscle biopsy (Procedure)

Outcomes

Primary Outcomes

Rate of glycogen resynthesis

Time Frame: Change from baseline to 1.5 hrs and 3.5 hrs post exercise bout. Biopsy 1 post-exercise pre nutrient intake 1 and compression (IPC) or heat, biopsy 2 post compression or heat, pre-nutrition intake 2, biopsy 3 at 210 min. Higher rate is better.

Leg skeletal muscle glycogen level assessment using assay kit

Muscle functional recovery: Skeletal muscle function

Time Frame: Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less fatigue is better.

Work fatigue (%) of the knee extensors measured using an isokinetic dynamometer

Muscle functional recovery: Perceived muscle soreness

Time Frame: Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less soreness is better.

Knee extensor muscle soreness on a visual analog scale (VAS) of 100 mm after stepping on and off a 40 cm (female) or 45 cm (male) box three times

Secondary Outcomes

  • Serum Glucose(Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs)
  • mRNA expression of genes involved in regulation of glucose and glycogen metabolism and muscle functional recovery(Change from baseline to 1.5 hours and 3.5 hours post exercise bout. Biopsy 1 post-exercise pre- nutrient intake 1 and compression (IPC) or heat, biopsy 2 post compression or heat and pre- nutrition intake 2, biopsy 3 at 210 min. Higher expression better.)
  • Serum insulin(Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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