Clinical trial NCT04707963: Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults
Official title: Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: resistance training
muscle hypertrophy
muscle quality
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Edward Via College of Osteopathic Medicine-Auburn
name: The Peanut Institute
First posted: 2021-01-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: 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 untrained men and women ages 18-30

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.

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)
* pregnant or trying to become pregnant

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 appendicular lean mass
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 fecal microbiome composition
timeFrame: 0-10 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Associate Professor
name: Michael D Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sexton CL, Smith MA, Smith KS, Osburn SC, Godwin JS, Ruple BA, Hendricks AM, Mobley CB, Goodlett MD, Fruge AD, Young KC, Roberts MD. Effects of Peanut Protein Supplementation on Resistance Training Adaptations in Younger Adults. Nutrients. 2021 Nov 9;13(11):3981. doi: 10.3390/nu13113981.