Back to resultsAccelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
Primary Purpose
Muscle Recovery, Muscle Soreness, Glycogen Depletion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression sleeve
Heat therapy
Glycogen-depleting exercise session
Nutrient Intake (beverage)
Skeletal muscle biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Recovery focused on measuring muscle glycogen, glycogen replenishment, muscle recovery, intermittent pneumatic compression, IPC, heat therapy
Eligibility Criteria
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.
Sites / Locations
- Purdue University, Department of Health & Kinesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intermittent pneumatic compression
Heat therapy
Arm Description
IPC sleeve device on leg
Custom water-circulating garment on leg
Outcomes
Primary Outcome Measures
Rate of glycogen resynthesis
Leg skeletal muscle glycogen level assessment using assay kit
Muscle functional recovery: Skeletal muscle function
Work fatigue (%) of the knee extensors measured using an isokinetic dynamometer
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
Secondary Outcome Measures
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)
Serum insulin
Blood test using ELISA kit
Serum Glucose
Blood test using ELISA kit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04371237
Brief Title
Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
Official Title
Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
December 21, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PepsiCo Global R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Recovery, Muscle Soreness, Glycogen Depletion
Keywords
muscle glycogen, glycogen replenishment, muscle recovery, intermittent pneumatic compression, IPC, heat therapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent pneumatic compression
Arm Type
Experimental
Arm Description
IPC sleeve device on leg
Arm Title
Heat therapy
Arm Type
Experimental
Arm Description
Custom water-circulating garment on leg
Intervention Type
Device
Intervention Name(s)
Compression sleeve
Other Intervention Name(s)
IPC
Intervention Description
From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour
Intervention Type
Device
Intervention Name(s)
Heat therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Glycogen-depleting exercise session
Intervention Description
Prolonged intermittent high intensity running (LIST protocol)
Intervention Type
Other
Intervention Name(s)
Nutrient Intake (beverage)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Skeletal muscle biopsy
Intervention Description
Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
Primary Outcome Measure Information:
Title
Rate of glycogen resynthesis
Description
Leg skeletal muscle glycogen level assessment using assay kit
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.
Title
Muscle functional recovery: Skeletal muscle function
Description
Work fatigue (%) of the knee extensors measured using an isokinetic dynamometer
Time Frame
Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less fatigue is better.
Title
Muscle functional recovery: Perceived muscle soreness
Description
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
Time Frame
Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less soreness is better.
Secondary Outcome Measure Information:
Title
mRNA expression of genes involved in regulation of glucose and glycogen metabolism and muscle functional recovery
Description
Leg skeletal muscle fiber analysis determined using RT-PCR (Real-time polymerase chain reaction)
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.
Title
Serum insulin
Description
Blood test using ELISA kit
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)
Title
Serum Glucose
Description
Blood test using ELISA kit
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Roseguini, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University, Department of Health & Kinesiology
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
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