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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04127240
Other study ID # 1712006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2017
Est. completion date November 10, 2018

Study information

Verified date October 2019
Source South Dakota State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date November 10, 2018
Est. primary completion date November 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 and older

- Upward mobile ability

Exclusion Criteria:

- Under the age of 65

- Immobility

Study Design


Related Conditions & MeSH terms


Intervention

Other:
DASH diet containing daily intakes of red meat
Each participant was randomized to consume 3 or 6 ounces of red meat as a part of the DASH dietary pattern for 12-weeks.

Locations

Country Name City State
United States South Dakota State University Brookings South Dakota

Sponsors (1)

Lead Sponsor Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight Measured by bioelectrical impedance Change in body weight from baseline to 3 months
Primary Hand grip strength Measured by a hand-held dynamometer Change in strength from baseline to 3 months
Primary Glucose Measure serum glucose using colorimetry assay Change in glucose concentrations from baseline to 3 months
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