Recruiting

Graded Protein Intake

Sponsor:

Wake Forest University

Code:

NCT04845282

Conditions

Sarcopenia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

Graded Protein plus Resistance Training

RDA Protein plus Resistance Training

Study Details

Brief summary:

This clinical trial is intended to evaluate the effects of protein intake graded to resistance training volume over a 10-week period on macroscopic skeletal muscle adaptations and body composition. Briefly, all participants will complete a progressive resistance training protocol for 10 weeks, with one group consuming a constant amount of total daily protein (RDA of 0.8g/kg/day) to serve as an active comparator. The alternative group will consume total daily protein and protein supplement in a graded manner designed to increase as overall training volume increases. Protein intake and resistance training protocols are described in full elsewhere. The investigators hypothesize that the graded protein intake group will see larger benefits to skeletal muscle function, size, and body composition than the active comparator.

Conditions

Sarcopenia

Study ID

NCT04845282

Start date

Aug 28, 2021

Status verified date

Apr, 2022

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • >55 years of age
  • Able to provide transportation to resistance training sessions and data collection days
  • Able to read and write in English
  • Have not adhered to a progressive resistance training program in the past three months
  • Able to ambulate without assistance
  • Willingness to provide informed consent and participate in the intervention
  • Do not have a comorbidity that could be exacerbated by study protocol, such as severe cardiovascular disease, type I or type II diabetes, renal failure, liver disorders, or thyroid disease OR can provide explicit written consent from a primary care physician indicating that they can participate in this study.

Exclusion Criteria:

  • Currently consuming an agent known to be confounding to skeletal muscle adaptation, such supplements that include, but are not limited to creatine monohydrate, growth hormone, or testosterone replacement therapy
  • Currently undergoing cancer treatment
  • Used whey protein supplements within the past three months
  • Pre-menopausal status for women

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Graded Protein plus Resistance Training

This group will participate in a progressive resistance training program and will be instructed to consume a diet with a gradation of protein over the 12 week study duration.

active comparator: RDA Protein plus Resistance Training

This group will participate in a progressive resistance training program and will be instructed to consume a diet with the recommended daily allowance of protein over the 12 week study duration.

Interventions

Graded Protein plus Resistance Training

Participants will be counseled to consume the specific level of dietary protein plus the protein supplement is MusclePharm Combat 100% Whey. Specific values per week are listed below:

Week 1: 25 g of protein supplement (0.8 g protein/kg body weight) Week 2: 25 g of protein supplement (1.0 g protein/kg body weight) Week 3: 50 g of protein supplement (1.2 g protein/kg body weight) Week 4: 50 g of protein supplement (1.4 g protein/kg body weight) Week 5: 50 g of protein supplement (1.4 g protein/kg body weight) Week 6: 75 g of protein supplement (1.6 g protein/kg body weight) Week 7: 75 g of protein supplement (1.8 g protein/kg body weight) Week 8: 75 g of protein supplement (2.0 g protein/kg body weight) Week 9: 75 g of protein supplement (2.2 g protein/kg body weight) Week 10: 100 g of protein supplement (2.2 g protein/kg body weight)

RDA Protein plus Resistance Training

Participants will be counseled to consume the RDA level of protein (0.8g/kg/day) utilizing only dietary protein.

Primary outcome measure

  • Change in Whole body lean soft tissue mass (kg) from baseline to 10 weeks [ Time Frame: Baseline and 10 weeks ]
  • Change in Whole body fat mass (kg) from baseline to 10 weeks [ Time Frame: Baseline and 10 weeks ]
  • Change in regional (specifically the lower extremity) lean soft tissue mass (kg) from baseline to 10 weeks [ Time Frame: Baseline and week 10 ]
  • Change in regional (specifically the lower extremity) fat mass (kg) from baseline to 10 weeks [ Time Frame: Baseline and week 10 ]

Central Contacts and Locations

Central contacts

John M Michel, B.S.

2059077830michjm20@wfu.edu

John M Michel

jmmichel54@gmail.com

Locations

Wake Forest University Clinical Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27105

Contacts

Ashlyn A Swafford, M.S.

517-227-4568swafaa18@wfu.edu

Jeffrey A Katula, Ph.D.

336-758-3612katulaj@wfu.edu

More Information

Sponsor

Wake Forest University

Last update posted

Apr 27, 2022

Last verified

Apr, 2022

Keywords

  • Protein
  • Skeletal Muscle
  • Body Composition
  • Ultrasonography
  • Resistance Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University on 2022-04-27.