Effects of Graded Protein Intake on Body Composition in Older Adults

NCT04845282 | Unknown

• 1 other identifier: IRB00024112
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Whole body lean soft tissue mass (kg) from baseline to 10 weeks

  Lean soft tissue mass (LSTM) will be assessed via dual-energy X-ray absorptiometry (DXA) (GE Lunar iDXA) both pre- and post-intervention. Scans will be performed at the same time of day (0600-1300), in a fasted state (\>10 hrs fasted), and at least 72 hours after the final bout of training to account for cellular edema at baseline and after 10 wk of intervention on participants wearing general sports attire. Participants will remain supine and aligned with the scanner table as prescribed by the manufacturer. Data from DXA scans will include total body lean soft tissue mass in kilograms as assessed by the accompanying software. Testing will occur at the Wake Forest University Worrell Professional Center (HES) in the Body Composition Laboratory.

  Baseline and 10 weeks

• Change in Whole body fat mass (kg) from baseline to 10 weeks

  Lean soft tissue mass (LSTM) will be assessed via dual-energy X-ray absorptiometry (DXA) (GE Lunar iDXA) both pre- and post-intervention. Scans will be performed at the same time of day (0600-1300), in a fasted state (\>10 hrs fasted), and at least 72 hours after the final bout of training to account for cellular edema at baseline and after 10 wk of intervention on participants wearing general sports attire. Participants will remain supine and aligned with the scanner table as prescribed by the manufacturer. Data from DXA scans will include total body fat mass in kilograms as assessed by the accompanying software. Testing will occur at the Wake Forest University Worrell Professional Center (HES) in the Body Composition Laboratory.

  Baseline and 10 weeks

• Change in regional (specifically the lower extremity) lean soft tissue mass (kg) from baseline to 10 weeks

  Lean soft tissue mass (LSTM) will be assessed via dual-energy X-ray absorptiometry (DXA) (GE Lunar iDXA) both pre- and post-intervention. Scans will be performed at the same time of day (0600-1300), in a fasted state (\>10 hrs fasted), and at least 72 hours after the final bout of training to account for cellular edema at baseline and after 10 wk of intervention on participants wearing general sports attire. Participants will remain supine and aligned with the scanner table as prescribed by the manufacturer. Data from DXA scans will include lower extremity lean soft tissue mass in kilograms as assessed by the accompanying software. Testing will occur at the Wake Forest University Worrell Professional Center (HES) in the Body Composition Laboratory.

  Baseline and week 10

• Change in regional (specifically the lower extremity) fat mass (kg) from baseline to 10 weeks

  Lean soft tissue mass (LSTM) will be assessed via dual-energy X-ray absorptiometry (DXA) (GE Lunar iDXA) both pre- and post-intervention. Scans will be performed at the same time of day (0600-1300), in a fasted state (\>12 hrs fasted), and at least 72 hours after the final bout of training to account for cellular edema at baseline and after 10 wk of intervention on participants wearing general sports attire. Participants will remain supine and aligned with the scanner table as prescribed by the manufacturer. Data from DXA scans will include lower extremity fat mass in kilograms as assessed by the accompanying software. Testing will occur at the Wake Forest University Worrell Professional Center (HES) in the Body Composition Laboratory.

  Baseline and week 10

Secondary Outcomes (4)

• Change in Muscular Function (3 repetition maximum) from baseline to 5 weeks to 10 weeks

  Baseline, Week 5, and Week 10

• Change in Muscular Function (isokinetic dynamometry) from baseline to 5 weeks to 10 weeks

  Baseline, Week 5, Week 10

• Change in Muscle Tissue Thickness from baseline to 10 weeks

  Baseline, Week 10

• Height and weight will be combined to report change in BMI in kg/m^2 from baseline to 5 weeks to 10 weeks

  Baseline, Week 5, Week 10

Study Arms (2)

Graded Protein plus Resistance Training

EXPERIMENTAL

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.

Dietary Supplement: Graded Protein plus Resistance Training

RDA Protein plus Resistance Training

ACTIVE COMPARATOR

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.

Dietary Supplement: RDA Protein plus Resistance Training

Interventions

Graded Protein plus Resistance Training DIETARY_SUPPLEMENT

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)

Graded Protein plus Resistance Training

RDA Protein plus Resistance Training DIETARY_SUPPLEMENT

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

RDA Protein plus Resistance Training

Eligibility Criteria

• Age: 55 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Clinical Research Center

Winston-Salem, North Carolina, 27105, United States

RECRUITING

Related Publications (2)

• Devries MC, Sithamparapillai A, Brimble KS, Banfield L, Morton RW, Phillips SM. Changes in Kidney Function Do Not Differ between Healthy Adults Consuming Higher- Compared with Lower- or Normal-Protein Diets: A Systematic Review and Meta-Analysis. J Nutr. 2018 Nov 1;148(11):1760-1775. doi: 10.1093/jn/nxy197.

  PMID: 30383278 BACKGROUND

• American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.

  PMID: 19204579 BACKGROUND

Related Links

• Whey Protein to be used

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gary D Miller, Ph.D.

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Michel, B.S.

CONTACT

2059077830; michjm20@wfu.edu

John M Michel

CONTACT

jmmichel54@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be aware of their intervention, but the primary investigator and research staff performing assessments will not be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized into one of two groups. The first group will consume a set schedule of additional dietary protein, while the second group will consume a diet with the recommended dietary allowance of protein.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 14, 2021
• Study Start: August 28, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)