Clinical trial NCT04371237: 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
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Recovery
Muscle Soreness
Glycogen Depletion
Keywords: muscle glycogen
glycogen replenishment
muscle recovery
intermittent pneumatic compression
IPC
heat therapy
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of glycogen resynthesis
timeFrame: 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.
measure: Muscle functional recovery: Skeletal muscle function
timeFrame: Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less fatigue is better.
measure: Muscle functional recovery: Perceived muscle soreness
timeFrame: Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less soreness is better.
Secondary outcomes:
measure: mRNA expression of genes involved in regulation of glucose and glycogen metabolism and muscle functional recovery
timeFrame: 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.
measure: Serum insulin
timeFrame: Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs)
measure: Serum Glucose
timeFrame: Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University, Department of Health & Kinesiology
state: Indiana
Study officials:
affiliation: Purdue University
name: Bruno Roseguini, PhD
role: PRINCIPAL_INVESTIGATOR
References: