Skip to main content
OpenTrials
Completed

NCT Number: NCT04371237

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Muscle Recovery Body Temperature Changes Glycogen Depletion Heat Stress Disorders Hyperthermia Muscle Soreness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University, Department of Health & Kinesiology

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • Smoking
  • 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.

Treatment and study plan

Compression sleeve

Device

From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour

Other names: IPC

Heat therapy

Device

Custom leg garment with one leg heated by circulating hot water approx 40 degrees C, the other leg approx 32 degrees C (thermoneutral) for 1 hour

Glycogen-depleting exercise session

Other

Prolonged intermittent high intensity running (LIST protocol)

Nutrient Intake (beverage)

Other

Post-exercise, all participants will receive a beverage containing 1.0 g/kg carbohydrate and 0.3 g/kg protein from the mixture of Gatorade Recover Protein Shake and Gatorade Thirst Quencher

Skeletal muscle biopsy

Procedure

Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. mRNA expression of genes involved in regulation of glucose and glycogen metabolism and muscle functional recovery

    Time frame: 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.

    Leg skeletal muscle fiber analysis determined using RT-PCR (Real-time polymerase chain reaction)

  2. Serum insulin

    Time frame: Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs)

    Blood test using ELISA kit

  3. Serum Glucose

    Time frame: Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs

    Blood test using ELISA kit

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 1, 2020
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.