Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2019
CompletedFirst Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedMarch 10, 2021
March 1, 2021
1.3 years
April 29, 2020
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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)
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
Study Arms (2)
Intermittent pneumatic compression
EXPERIMENTALIPC sleeve device on leg
Heat therapy
EXPERIMENTALCustom water-circulating garment on leg
Interventions
From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour
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
Prolonged intermittent high intensity running (LIST protocol)
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
Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
Eligibility Criteria
You may qualify if:
- Subjects will be male and female participants in good health
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University, Department of Health & Kinesiology
West Lafayette, Indiana, 47907, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Roseguini, PhD
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 1, 2020
Study Start
September 19, 2018
Primary Completion
December 21, 2019
Study Completion
December 21, 2019
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share