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

Muscle Soreness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371237
• Other study ID #: PEP-1723
• Status: Completed
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: December 21, 2019

Study information

• Verified date: March 2021
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 21, 2019
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glycogen Depletion
• Muscle Recovery
• Muscle Soreness
• Myalgia

Intervention

Device:
• Compression sleeve
From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour
• 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

Other:
• Glycogen-depleting exercise session
Prolonged intermittent high intensity running (LIST protocol)
• 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

Locations

Country	Name	City	State
United States	Purdue University, Department of Health & Kinesiology	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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)
Secondary	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