- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015479
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
Open-label Randomized Controlled Trial Investigating the Effects of Peanut Protein Powder Supplement on Muscle Growth, Muscle Quality and Other Health Biomarkers in Older Adults Engaging in a Ten-week, Whole-body Resistance Training Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aging is associated with declines in muscle mass, physical strength and physical function. Adequate quality protein intake in aging adults is critical to preventing functional decline. Peanuts provide a unique blend of amino acids that can provide several health benefits to aging adults. While supplementing with peanut protein (PP) powder as part of a resistance training program may increase myofibrillar protein synthesis (i.e., the gold standard molecular assessment in deciphering a muscle-building response), and improve skeletal muscle quality and body composition, no study to date has made this determination.
This is a two-phase study using both novel and conventional methods to assess how PP supplementation affects muscle tissue in older individuals who engage in resistance training. These two phases will be conducted as part of a 10-week randomized controlled trial in which men and women aged 50 years and older (n=60), will be stratified by gender and randomized to a resistance training intervention (whole body, two days per week) with PP powder (72g daily; n=15 males, n=15 females) provided during the intervention (immediate group, IG) or after the intervention (wait-list control, WLC, n=15 males, n=15 females). The aims of this study are to determine the acute (deuterium oxide tracer) and chronic (peripheral quantitative computed tomography) effects of PP during resistance training on skeletal muscle myofibrillar protein synthesis rates, changes in skeletal muscle size and quality, changes in whole and appendicular body composition (dual energy x-ray absorptiometry), changes in inflammatory markers and the fecal microbiome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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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)
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
|
Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
|
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
|
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 total muscle cross-sectional area, subcutaneous adipose tissue area, total intra- and inter-muscular adipose tissue area and overall muscle density
|
0-10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in whole-body and appendicular body composition
Time Frame: 0-10 weeks
|
dual energy x-ray absorptiometry (DXA)
|
0-10 weeks
|
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 inflammatory biomarkers
Time Frame: 0-10 weeks
|
serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine
|
0-10 weeks
|
Change in fecal microbiome composition
Time Frame: 0-10 weeks
|
alpha- and beta-diversity of 16S bacterial rDNA
|
0-10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Roberts, PhD, Auburn University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-249
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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