Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults

Sponsor

Auburn University (Other)

Overall Status

Completed

CT.gov ID

NCT04015479

Collaborator

Edward Via Virginia College of Osteopathic Medicine (Other), The Peanut Institute (Other)

Enrollment

Location

Arms

7.2

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the adaptations in skeletal muscle that occur in response to 10 weeks of weight training with or without peanut protein supplementation in older adult men and women.

Condition or Disease	Intervention/Treatment	Phase
Aging Sarcopenia	Dietary Supplement: Peanut Protein Powder Behavioral: Full body resistance training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intervention group will receive the supplement during the study period and the wait-listed control group will receive the supplement after the study period. Both groups will participate in resistance training during the 10 week periodIntervention group will receive the supplement during the study period and the wait-listed control group will receive the supplement after the study period. Both groups will participate in resistance training during the 10 week period

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

PI and Co-Is will be blind to participant randomization. One study staff member will be responsible for administering the supplements to participants per randomization

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 26, 2019

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

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	Dietary Supplement: Peanut Protein Powder Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water Behavioral: Full body resistance training 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	Behavioral: Full body resistance training Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)

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

Dietary Supplement: Peanut Protein Powder

Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water

Behavioral: Full body resistance training

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

Behavioral: Full body resistance training

Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)

Outcome Measures

Primary Outcome Measures

Change in acute myofibrillar protein synthesis rates [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 mid-thigh skeletal muscle area and quality [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

Secondary Outcome Measures

Change in whole-body and appendicular body composition [0-10 weeks]
dual energy x-ray absorptiometry (DXA)
Change in Type I and II Muscle Fiber Cross-Sectional Area [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
Change in leg extensor isokinetic dynamometry [0-10 weeks]
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
Change in inflammatory biomarkers [0-10 weeks]
serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine
Change in fecal microbiome composition [0-10 weeks]
alpha- and beta-diversity of 16S bacterial rDNA

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)