Muscle RecoveryNCT04371237
Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
A study testing Compression sleeve, Heat therapy and Glycogen-depleting exercise session in people with Muscle Recovery and Muscle Soreness, run by PepsiCo Global R&D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Recovery, Muscle Soreness, Glycogen Depletion
- What is being tested?
- Compression sleeve, Heat therapy and Glycogen-depleting exercise session
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2018to 21 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Any medication
- Lactose intolerance
- Participation in another study within the previous 30 days or in a PepsiCo funded study within the past 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University, Department of Health & Kinesiology
West Lafayette, Indiana, 47907
About this study
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.
- Conditions
- Muscle Recovery, Muscle Soreness, Glycogen Depletion
- Being tested
- Compression sleeve, Heat therapy, Glycogen-depleting exercise session, Nutrient Intake (beverage), Skeletal muscle biopsy
- Keywords
- muscle glycogen, glycogen replenishment, muscle recovery, intermittent pneumatic compression, IPC, heat therapy
- Medical subject headings
- Myalgia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression sleeveDevice
Also called IPC
From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour
Heat therapyDevice
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 sessionOther
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 biopsyProcedure or surgery
Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
| Study group | Role | What they receive |
|---|---|---|
| Intermittent pneumatic compression | Experimental | IPC sleeve device on leg Receives: Device: Compression sleeve; Other: Glycogen-depleting exercise session; Other: Nutrient Intake (beverage); Procedure: Skeletal muscle biopsy |
| Heat therapy | Experimental | Custom water-circulating garment on leg Receives: Device: Heat therapy; Other: Glycogen-depleting exercise session; Other: Nutrient Intake (beverage); Procedure: Skeletal muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of glycogen resynthesis
Leg skeletal muscle glycogen level assessment using assay kit
Measured: 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
Measured: 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
Measured: 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
Leg skeletal muscle fiber analysis determined using RT-PCR (Real-time polymerase chain reaction)
Measured: 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
Measured: 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
Measured: Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start19 Sep 2018
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Roseguini, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371237
- Sponsor's protocol ID
- PEP-1723
- Status last verified
- Mar 2021
- First submitted
- 29 Apr 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
- ClinicalTrials.gov ID
- NCT04371237
- Acronym / sponsor ID
- PEP-1723
- Conditions
- Muscle Recovery, Muscle Soreness, Glycogen Depletion
- Keywords
- muscle glycogen, glycogen replenishment, muscle recovery, intermittent pneumatic compression, IPC, heat therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent pneumatic compression | Experimental | Device: Compression sleeve, Other: Glycogen-depleting exercise session, Other: Nutrient Intake (beverage), Procedure: Skeletal muscle biopsyIPC sleeve device on leg |
| Heat therapy | Experimental | Device: Heat therapy, Other: Glycogen-depleting exercise session, Other: Nutrient Intake (beverage), Procedure: Skeletal muscle biopsyCustom water-circulating garment on leg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- History of deep vein thrombosis
- Obesity (BMI > 30 kg/m2)
- Hypertension (resting SBP > 140/90 mmHg)
- Smoking
- Pregnant, planning to become pregnant, or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression sleeveAlso: IPCFrom foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour | Device | Intermittent pneumatic compression |
| Heat therapyCustom 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 | Device | Heat therapy |
| Glycogen-depleting exercise sessionProlonged intermittent high intensity running (LIST protocol) | Other | Heat therapy, Intermittent pneumatic compression |
| 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 | Other | Heat therapy, Intermittent pneumatic compression |
| Skeletal muscle biopsyVastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique | Procedure or surgery | Heat therapy, Intermittent pneumatic compression |
Primary outcome
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
3 secondary outcomes
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.
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Roseguini, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression sleeve, Heat therapy and Glycogen-depleting exercise session in people with Muscle Recovery and Muscle Soreness, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.