NCT04127240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

October 10, 2019

Last Update Submit

October 11, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Body weight

    Measured by bioelectrical impedance

    Change in body weight from baseline to 3 months

  • Hand grip strength

    Measured by a hand-held dynamometer

    Change in strength from baseline to 3 months

  • Glucose

    Measure serum glucose using colorimetry assay

    Change in glucose concentrations from baseline to 3 months

Study Arms (2)

Meat assignment in DASH intervention

EXPERIMENTAL

Participants consumed 3 ounces of red meat per day as a part of the DASH diet.

Other: DASH diet containing daily intakes of red meat

Meat allocation in DASH intervention

EXPERIMENTAL

Participants consumed 6 ounces of red meat per day as a part of the DASH diet.

Other: DASH diet containing daily intakes of red meat

Interventions

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

Meat allocation in DASH interventionMeat assignment in DASH intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • and older
  • Upward mobile ability

You may not qualify if:

  • Under the age of 65
  • Immobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Dakota State University

Brookings, South Dakota, 57006, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesitySarcopenia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Study Officials

  • Cydne A Perry, PhD

    South Dakota State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 15, 2019

Study Start

June 15, 2017

Primary Completion

November 10, 2018

Study Completion

November 10, 2018

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations