- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04707963
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Auburn University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- body mass index (body mass/height squared) less than 35 kg/m2
- resting blood pressure averaging less than 140/90 mmHg (with or without medication)
Exclusion Criteria:
- known peanut allergy
- actively participating in resistance training for more than 2 days/week
- any known overt cardiovascular or metabolic disease
- metal implants that will interfere with x-ray procedures
- medically necessary radiation exposure in the last six months (except dental x-ray)
- any medical condition that would contradict participating in an exercise program, giving blood or donating a skeletal muscle biopsy (i.e. blood clotting disorder or taking blood thinners)
- pregnant or trying to become pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Intervention Group
Participants will complete 10 weeks of twice-weekly whole body resistance training.
Peanut protein powder (72g/day) will be provided for daily consumption during the study period
|
Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
|
|
Active Comparator: Wait-list Control Group
Participants will complete 10 weeks of twice-weekly whole body resistance training.
Peanut protein powder will be provided after the study period
|
Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in acute myofibrillar protein synthesis rates
Time Frame: 24 hours
|
Change in right leg vastus lateralis myofibrillar protein synthesis rates using the integrated deuterium oxide technique from biopsies immediately before and 24 hours after resistance exercise Change in right leg vastus lateralis myofibrillar protein synthesis rates using the integrated deuterium oxide technique from biopsies immediately before and 24 hours after resistance exercise |
24 hours
|
|
Change in mid-thigh skeletal muscle area and quality
Time Frame: 0-10 weeks
|
Peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for overall muscle density (mg/cm^3)
|
0-10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Type I and II Muscle Fiber Cross-Sectional Area
Time Frame: 0-10 weeks
|
Muscle biopsy immunofluorescent staining for determination of type I and type II muscle fiber cross sectional area (fCSA) as a cellular determinant of skeletal muscle hypertrophy
|
0-10 weeks
|
|
Change in leg extensor isokinetic dynamometry
Time Frame: 0-10 weeks
|
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
|
0-10 weeks
|
|
Change in fecal microbiome composition
Time Frame: 0-10 weeks
|
alpha- and beta-diversity of 16S bacterial rDNA
|
0-10 weeks
|
|
Change in appendicular lean mass
Time Frame: 0-10 weeks
|
Change in lean mass (kg) of limbs as measured by dual energy x-ray absorptiometry (DXA)
|
0-10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael D Roberts, PhD, Associate professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-249B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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