The Effect of the DASH Diet Containing Meat on Muscle and Metabolic Health in Older Adults
Primary Purpose
Obesity, Sarcopenia, Aging
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH diet containing daily intakes of red meat
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 65 and older
- Upward mobile ability
Exclusion Criteria:
- Under the age of 65
- Immobility
Sites / Locations
- South Dakota State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Meat assignment in DASH intervention
Meat allocation in DASH intervention
Arm Description
Participants consumed 3 ounces of red meat per day as a part of the DASH diet.
Participants consumed 6 ounces of red meat per day as a part of the DASH diet.
Outcomes
Primary Outcome Measures
Body weight
Measured by bioelectrical impedance
Hand grip strength
Measured by a hand-held dynamometer
Glucose
Measure serum glucose using colorimetry assay
Secondary Outcome Measures
Full Information
NCT ID
NCT04127240
First Posted
October 10, 2019
Last Updated
October 11, 2019
Sponsor
South Dakota State University
1. Study Identification
Unique Protocol Identification Number
NCT04127240
Brief Title
The Effect of the DASH Diet Containing Meat on Muscle and Metabolic Health in Older Adults
Official Title
The Effect of Meat Intake as a Part of the DASH Diet on Indices of Muscular Fitness, Body Composition and Metabolic Health in Adults 65 and Older: A Controlled-Feeding Systems-Biology Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
November 10, 2018 (Actual)
Study Completion Date
November 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Dakota State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Age-related changes in body composition, muscular fitness, and metabolic health resulting in the onset of obesity, sarcopenia, and chronic diseases are profound public health issues that are in need of immediate attention. Effective and feasible methods, such as dietary therapies, are needed to improve health in older adults that in turn lead to independence, enhanced quality of life and reduced hospitalizations. Diet quality and dietary protein intake are vital for maintaining body composition, muscle mass and improved physical performance. Malnutrition in dietary protein intake is a major cause of reduced muscle mass, strength, and function in older adults. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is a high-quality therapeutic diet known to improve health status in various diverse and at-risk populations resulting in improved heart health, maintained cognitive function and reductions in metabolic diseases such as diabetes, metabolic syndrome, and nonalcoholic fatty liver disease. The primary protein recommendations of the DASH diet are poultry and fish and it is recommended to decrease or exclude red meats from the diet. However, studies have demonstrated that lean red meat incorporated into a DASH-like diet doesn't exacerbate cardiovascular health indices in adults, indicating that lean red meat can be included in the DASH diet without negative effects on heart health. Although studies have reported on the DASH diet in older adults, no studies have investigated the effect of the DASH diet containing lean red meat on measures of body composition, muscle mass or metabolic health under controlled-feeding conditions. The purpose of this study was to determine the effect of the DASH diet containing daily intakes of lean red meat on indicators of body composition, muscular fitness and biomarkers of metabolic health in adults 65 and older using controlled-feeding and systems biology approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sarcopenia, Aging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meat assignment in DASH intervention
Arm Type
Experimental
Arm Description
Participants consumed 3 ounces of red meat per day as a part of the DASH diet.
Arm Title
Meat allocation in DASH intervention
Arm Type
Experimental
Arm Description
Participants consumed 6 ounces of red meat per day as a part of the DASH diet.
Intervention Type
Other
Intervention Name(s)
DASH diet containing daily intakes of red meat
Intervention Description
Each participant was randomized to consume 3 or 6 ounces of red meat as a part of the DASH dietary pattern for 12-weeks.
Primary Outcome Measure Information:
Title
Body weight
Description
Measured by bioelectrical impedance
Time Frame
Change in body weight from baseline to 3 months
Title
Hand grip strength
Description
Measured by a hand-held dynamometer
Time Frame
Change in strength from baseline to 3 months
Title
Glucose
Description
Measure serum glucose using colorimetry assay
Time Frame
Change in glucose concentrations from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
65 and older
Upward mobile ability
Exclusion Criteria:
Under the age of 65
Immobility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cydne A Perry, PhD
Organizational Affiliation
South Dakota State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Dakota State University
City
Brookings
State/Province
South Dakota
ZIP/Postal Code
57006
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35287731
Citation
Perry CA, Van Guilder GP, Butterick TA. Decreased myostatin in response to a controlled DASH diet is associated with improved body composition and cardiometabolic biomarkers in older adults: results from a controlled-feeding diet intervention study. BMC Nutr. 2022 Mar 15;8(1):24. doi: 10.1186/s40795-022-00516-9.
Results Reference
derived
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The Effect of the DASH Diet Containing Meat on Muscle and Metabolic Health in Older Adults
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