Clinical trial NCT04015479: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Sarcopenia
Keywords: muscle protein synthesis
resistance training
protein supplementation
skeletal muscle physiology
inflammatory cytokines
fecal microbiome
plant protein
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Edward Via Virginia College of Osteopathic Medicine
name: The Peanut Institute
First posted: 2019-07-11
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 period
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change in acute myofibrillar protein synthesis rates
timeFrame: 24 hours
measure: Change in mid-thigh skeletal muscle area and quality
timeFrame: 0-10 weeks
Secondary outcomes:
measure: Change in whole-body and appendicular body composition
timeFrame: 0-10 weeks
measure: Change in Type I and II Muscle Fiber Cross-Sectional Area
timeFrame: 0-10 weeks
measure: Change in leg extensor isokinetic dynamometry
timeFrame: 0-10 weeks
measure: Change in inflammatory biomarkers
timeFrame: 0-10 weeks
measure: Change in fecal microbiome composition
timeFrame: 0-10 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Michael Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.