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

Primary Purpose

Aging, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peanut Protein Powder
Full body resistance training
Sponsored by
Auburn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring muscle protein synthesis, resistance training, protein supplementation, skeletal muscle physiology, inflammatory cytokines, fecal microbiome, plant protein

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Auburn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Intervention Group

Wait-list Control Group

Arm Description

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 complete 10 weeks of twice-weekly whole body resistance training. Peanut protein powder will be provided after the study period

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 9, 2019
Last Updated
January 10, 2021
Sponsor
Auburn University
Collaborators
Edward Via Virginia College of Osteopathic Medicine, The Peanut Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04015479
Brief Title
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
Edward Via Virginia College of Osteopathic Medicine, The Peanut Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Sarcopenia
Keywords
muscle protein synthesis, resistance training, protein supplementation, skeletal muscle physiology, inflammatory cytokines, fecal microbiome, plant protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 period
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Wait-list Control Group
Arm Type
Active Comparator
Arm Description
Participants will complete 10 weeks of twice-weekly whole body resistance training. Peanut protein powder will be provided after the study period
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanut Protein Powder
Intervention Description
Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
Intervention Type
Behavioral
Intervention Name(s)
Full body resistance training
Intervention Description
Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
Primary Outcome Measure Information:
Title
Change in acute myofibrillar protein synthesis rates
Description
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
Time Frame
24 hours
Title
Change in mid-thigh skeletal muscle area and quality
Description
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
Time Frame
0-10 weeks
Secondary Outcome Measure Information:
Title
Change in whole-body and appendicular body composition
Description
dual energy x-ray absorptiometry (DXA)
Time Frame
0-10 weeks
Title
Change in Type I and II Muscle Fiber Cross-Sectional Area
Description
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
Time Frame
0-10 weeks
Title
Change in leg extensor isokinetic dynamometry
Description
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
Time Frame
0-10 weeks
Title
Change in inflammatory biomarkers
Description
serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine
Time Frame
0-10 weeks
Title
Change in fecal microbiome composition
Description
alpha- and beta-diversity of 16S bacterial rDNA
Time Frame
0-10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Roberts, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33317565
Citation
Lamb DA, Moore JH, Smith MA, Vann CG, Osburn SC, Ruple BA, Fox CD, Smith KS, Altonji OM, Power ZM, Cerovsky AE, Ross CO, Cao AT, Goodlett MD, Huggins KW, Fruge AD, Young KC, Roberts MD. The effects of resistance training with or without peanut protein supplementation on skeletal muscle and strength adaptations in older individuals. J Int Soc Sports Nutr. 2020 Dec 14;17(1):66. doi: 10.1186/s12970-020-00397-y.
Results Reference
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Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults

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