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.

Study Overview

• Status: Completed
• Conditions: Muscle Soreness; Muscle Recovery; Glycogen Depletion
• Intervention / Treatment: Device: Compression sleeve; Other: Glycogen-depleting exercise session; Other: Nutrient Intake (beverage); Procedure: Skeletal muscle biopsy; Device: Heat therapy

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University, Department of Health & Kinesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects will be male and female participants in good health
2. 18-35 years of age
3. 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.
4. Understanding of the procedures to be undertaken as part of the study
5. Willingness to participate in exercise testing and follow instructions provided by the experimenter
6. Informed, voluntary, written consent to participate in the study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent pneumatic compression; IPC sleeve device on leg	Device: Compression sleeve; From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour; Other Names: IPC; Other: Glycogen-depleting exercise session; Prolonged intermittent high intensity running (LIST protocol); Other: Nutrient Intake (beverage); 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; Procedure: Skeletal muscle biopsy; Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
Experimental: Heat therapy; Custom water-circulating garment on leg	Other: Glycogen-depleting exercise session; Prolonged intermittent high intensity running (LIST protocol); Other: Nutrient Intake (beverage); 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; Procedure: Skeletal muscle biopsy; Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique; Device: Heat therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of glycogen resynthesis	Leg skeletal muscle glycogen level assessment using assay kit	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.
Muscle functional recovery: Skeletal muscle function	Work fatigue (%) of the knee extensors measured using an isokinetic dynamometer	Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less fatigue is better.
Muscle functional recovery: Perceived muscle soreness	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	Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less soreness is better.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRNA expression of genes involved in regulation of glucose and glycogen metabolism and muscle functional recovery	Leg skeletal muscle fiber analysis determined using RT-PCR (Real-time polymerase chain reaction)	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	Blood test using ELISA kit	Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs)
Serum Glucose	Blood test using ELISA kit	Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Bruno Roseguini, PhD, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): December 21, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: heat therapy; muscle recovery; intermittent pneumatic compression; IPC; muscle glycogen; glycogen replenishment
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: PEP-1723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No