NCT04015479

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 older adult men and women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

July 9, 2019

Last Update Submit

January 10, 2021

Conditions

Keywords

muscle protein synthesisresistance trainingprotein supplementationskeletal muscle physiologyinflammatory cytokinesfecal microbiomeplant protein

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Change in whole-body and appendicular body composition

    0-10 weeks

  • Change in Type I and II Muscle Fiber Cross-Sectional Area

    0-10 weeks

  • Change in leg extensor isokinetic dynamometry

    0-10 weeks

  • Change in inflammatory biomarkers

    0-10 weeks

  • Change in fecal microbiome composition

    0-10 weeks

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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 PowderBehavioral: Full body resistance training

Wait-list Control Group

ACTIVE COMPARATOR

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

Interventions

Peanut Protein PowderDIETARY_SUPPLEMENT

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

Immediate Intervention Group

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

Immediate Intervention GroupWait-list Control Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related 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.

    PMID: 33317565BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Michael Roberts, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 11, 2019

Study Start

September 26, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations