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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707963
• Other study ID #: 19-249B
• Status: Completed
• Phase: N/A
• Start date: February 6, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• 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 untrained men and women ages 18-30

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 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)

• pregnant or trying to become pregnant

Related Conditions & MeSH terms

• Sarcopenia

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 College of Osteopathic Medicine-Auburn, The Peanut Institute

Country where clinical trial is conducted

United States, 

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; 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 overall muscle density (mg/cm^3)	0-10 weeks
Secondary	Change in appendicular lean mass	Change in lean mass (kg) of limbs as measured by 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 fecal microbiome composition	alpha- and beta-diversity of 16S bacterial rDNA	0-10 weeks