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

• ClinicalTrials.gov Identifier: NCT04707963
• Recruitment Status: Completed
• First Posted: January 13, 2021
• Last Update Posted: June 9, 2021
• Sponsor: Auburn University
• Collaborators: Edward Via College of Osteopathic Medicine-Auburn; The Peanut Institute
• Information provided by (Responsible Party): Andrew Fruge, Auburn University

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 untrained men and women ages 18-30

Condition or disease	Intervention/treatment	Phase
Sarcopenia	Dietary Supplement: Peanut protein powder; Behavioral: Full body resistance training	Not Applicable

Detailed Description:

This is a two-phase study using both novel and conventional methods to assess how PP supplementation affects muscle tissue in young adults 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 18-30 years (n=40), will be stratified by gender and randomized to a resistance training intervention (whole body, two days per week) with PP powder (72g daily; n=10 males, n=10 females) provided during the intervention (immediate group, IG) or after the intervention (wait-list control, WLC, n=10 males, n=10 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 (Clinical Trial)
• Actual Enrollment: 56 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 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: Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults
• Actual Study Start Date: February 6, 2021
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: May 31, 2021

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)

Outcome Measures

Primary Outcome Measures :

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

   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 overall muscle density (mg/cm^3)

Secondary Outcome Measures :

1. Change in appendicular lean mass [ Time Frame: 0-10 weeks ]
   Change in lean mass (kg) of limbs as measured by 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 fecal microbiome composition [ Time Frame: 0-10 weeks ]
   alpha- and beta-diversity of 16S bacterial rDNA

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)
• pregnant or trying to become pregnant

Contacts and Locations

Locations

United States, Alabama

Auburn University

Auburn, Alabama, United States, 36849

Sponsors and Collaborators

Auburn University

Edward Via College of Osteopathic Medicine-Auburn

The Peanut Institute

Investigators

• Principal Investigator: Michael D Roberts, PhD; Associate Professor

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sexton CL, Smith MA, Smith KS, Osburn SC, Godwin JS, Ruple BA, Hendricks AM, Mobley CB, Goodlett MD, Frugé AD, Young KC, Roberts MD. Effects of Peanut Protein Supplementation on Resistance Training Adaptations in Younger Adults. Nutrients. 2021 Nov 9;13(11). pii: 3981. doi: 10.3390/nu13113981.

• Responsible Party: Andrew Fruge, Assistant Professor, Auburn University
• ClinicalTrials.gov Identifier: NCT04707963
• Other Study ID Numbers: 19-249B
• First Posted: January 13, 2021
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Deidentified anthropometric, physiological, biological and performance data may be requested

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrew Fruge, Auburn University:

resistance training; muscle hypertrophy; muscle quality

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical