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Completed

NCT Number: NCT04015479

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Peanut Protein Powder

Dietary Supplement

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

Full body resistance training

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in whole-body and appendicular body composition

    Time frame: 0-10 weeks

    dual energy x-ray absorptiometry (DXA)

  2. 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

  3. Change in leg extensor isokinetic dynamometry

    Time frame: 0-10 weeks

    maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)

  4. Change in inflammatory biomarkers

    Time frame: 0-10 weeks

    serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine

  5. Change in fecal microbiome composition

    Time frame: 0-10 weeks

    alpha- and beta-diversity of 16S bacterial rDNA

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Collaborators

  • Edward Via Virginia College of Osteopathic Medicine
  • The Peanut Institute

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2019
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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