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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04015479
Other study ID # 19-249
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2019
Est. completion date May 1, 2020

Study information

Verified date January 2021
Source Auburn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States Auburn University Auburn Alabama

Sponsors (3)

Lead Sponsor Collaborator
Auburn University Edward Via Virginia College of Osteopathic Medicine, The Peanut Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 hours
Primary 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 0-10 weeks
Secondary Change in whole-body and appendicular body composition dual energy x-ray absorptiometry (DXA) 0-10 weeks
Secondary 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 0-10 weeks
Secondary Change in leg extensor isokinetic dynamometry maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex) 0-10 weeks
Secondary Change in inflammatory biomarkers serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine 0-10 weeks
Secondary Change in fecal microbiome composition alpha- and beta-diversity of 16S bacterial rDNA 0-10 weeks
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