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Effects of Graded Protein Intake on Body Composition in Older Adults (GPI)

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ClinicalTrials.gov Identifier: NCT04845282
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Gary Miller, Wake Forest University

Brief Summary:
This clinical trial is intended to evaluate the effects of protein intake graded to resistance training volume over a 12-week period on macroscopic skeletal muscle adaptations and body composition. Briefly, all participants will complete a progressive resistance training protocol for 12 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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Graded Protein plus Resistance Training Dietary Supplement: RDA Protein plus Resistance Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Investigator)
Masking Description: Participants will be aware of their intervention, but the primary investigator and research staff performing assessments will not be masked.
Primary Purpose: Basic Science
Official Title: Effects of Graded Protein Intake and Resistance Training on Body Composition in Older Adults
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
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.
Dietary Supplement: 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 + 1.6 g protein/kg body weight Week 8: 75 g of protein supplement + 1.8 g protein/kg body weight Week 9: 75 g of protein supplement + 2.0 g protein/kg body weight Weeks 10-12: 100 g of protein supplement + 2.0 g protein/kg body weight


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.
Dietary Supplement: RDA Protein plus Resistance Training
Participants will be counseled to consume the RDA level of protein (0.8g/kg/day) utilizing 25g of whey protein supplement per day to enhance adherence to protein intake.




Primary Outcome Measures :
  1. Change in Whole body lean soft tissue mass (kg) from baseline to 12 weeks [ Time Frame: Baseline and 12 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 (0800-1300), 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 12 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.

  2. Change in Whole body fat mass (kg) from baseline to 12 weeks [ Time Frame: Baseline and 12 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 (0800-1300), 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 12 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.

  3. Change in regional (specifically the lower extremity) lean soft tissue mass (kg) from baseline to 12 weeks [ Time Frame: Baseline and week 12 ]
    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 (0800-1300), 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 12 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.

  4. Change in regional (specifically the lower extremity) fat mass (kg) from baseline to 12 weeks [ Time Frame: Baseline and week 12 ]
    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 (0800-1300), 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 12 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.


Secondary Outcome Measures :
  1. Change in Muscular Function (3 repetition maximum) from baseline to 6 weeks to 12 weeks [ Time Frame: Baseline, Week 6, and Week 12 ]
    3 repetition maximums (RMs) will be assessed at pre-, week 6, and post-intervention as described in Table 1 in the support documentation. 3 RMs will be collected for the bilateral leg press and the bilateral leg extension to be considered for analysis. Participants will complete 3 RM testing under the supervision of trained research staff. Participants will perform three repetitions at a given load and progress at their own pace until endpoints of testing are reached. Endpoints are defined as the inability to complete a given load for 3 repetitions, non-adherence to proper form or full range of motion, or the voluntary cessation of exercise by the participant.

  2. Change in Muscular Function (isokinetic dynamometry) from baseline to 6 weeks to 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Peak Torque will be assessed via isokinetic dynamometry. Participants will be seated and strapped into a Humac NORM isokinetic dynamometer (Computer Sports Medicine Inc., Stoughton, MA) ensuring that their hip angle is ~90 degrees. The input axis of the dynamometer will be aligned with the lateral epicondyle of the left femur. All measures will be taken in the left leg, and will be taken in duplicate. The highest peak torque produced throughout either trial will be used. Dynamometry measures will be taken at pre-, week 6, and post-intervention.

  3. Change in Muscle Tissue Thickness from baseline to 12 weeks [ Time Frame: Baseline, Week 12 ]
    Muscle tissue thickness of the vastus lateralis (VL) will be assessed via 6-13 MHz transducer muscular ultrasound (SonoSite M-Turbo), at least 72 hours after completion of the most recent training session. Ultrasonography will take place at the midway point between the iliac crest and the patella of the right femur, with subjects in a supine position. Participants will be instructed to assume a supine position for >10 minutes to account for fluid shifting. Duplicate measures will be taken and the average muscle tissue thickness (MT) will be recorded. Testing will take place at HES in the Pulmonary Function and Ultrasound Laboratory.

  4. Height and weight will be combined to report change in BMI in kg/m^2 from baseline to 6 weeks to 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Height and body mass measures will be collected via wall-mounted stadiometer (Detecto) and digital scale (Tanita) respectively with heights and weights collected to the nearest 0.1 kg and 0.5 cm. Height and weight measures will be used to compute body mass index (BMI) defined as weight in kilograms divided by height in meters squared (kg/m^2).



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Ages Eligible for Study:   55 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  • 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
  • Currently undergoing cancer treatment
  • Used whey protein supplements within the past three months
  • Pre-menopausal status for women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845282


Contacts
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Contact: John M Michel, B.S. 2059077830 michjm20@wfu.edu
Contact: John M Michel jmmichel54@gmail.com

Locations
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United States, North Carolina
Wake Forest University Clinical Research Center Recruiting
Winston-Salem, North Carolina, United States, 27105
Contact: Ashlyn A Swafford, M.S.    517-227-4568    swafaa18@wfu.edu   
Contact: Jeffrey A Katula, Ph.D.    336-758-3612    katulaj@wfu.edu   
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Gary D Miller, Ph.D. Wake Forest University
Additional Information:
Publications:
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Responsible Party: Gary Miller, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT04845282    
Other Study ID Numbers: IRB00024112
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gary Miller, Wake Forest University:
Protein
Skeletal Muscle
Body Composition
Ultrasonography
Resistance Training
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical