ObesityNCT04127240
The Effect of the DASH Diet Containing Meat on Muscle and Metabolic Health in Older Adults
A study testing DASH diet containing daily intakes of red meat in people with Obesity and Sarcopenia, run by South Dakota State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sarcopenia, Aging
- What is being tested?
- DASH diet containing daily intakes of red meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 and older
- Upward mobile ability
Who cannot join
- Under the age of 65
- Immobility
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University
Brookings, South Dakota, 57006
About this study
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
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.
- Conditions
- Obesity, Sarcopenia, Aging
- Being tested
- DASH diet containing daily intakes of red meat
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH diet containing daily intakes of red meatOther
Each participant was randomized to consume 3 or 6 ounces of red meat as a part of the DASH dietary pattern for 12-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Meat assignment in DASH intervention | Experimental | Participants consumed 3 ounces of red meat per day as a part of the DASH diet. Receives: 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. Receives: Other: DASH diet containing daily intakes of red meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured by bioelectrical impedance
Measured: Change in body weight from baseline to 3 months
Hand grip strength
Measured by a hand-held dynamometer
Measured: Change in strength from baseline to 3 months
Glucose
Measure serum glucose using colorimetry assay
Measured: Change in glucose concentrations from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start15 Jun 2017
- Primary completion10 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cydne Perry, South Dakota State University
- Investigators
- Cydne A Perry, PhD, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127240
- Sponsor's protocol ID
- 1712006
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35287731
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04127240
- Acronym / sponsor ID
- 1712006
- Conditions
- Obesity, Sarcopenia, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meat assignment in DASH intervention | Experimental | Other: DASH diet containing daily intakes of red meatParticipants consumed 3 ounces of red meat per day as a part of the DASH diet. |
| Meat allocation in DASH intervention | Experimental | Other: DASH diet containing daily intakes of red meatParticipants consumed 6 ounces of red meat per day as a part of the DASH diet. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 and older
- Upward mobile ability
Key exclusion criteria (2 listed)
- Under the age of 65
- Immobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH diet containing daily intakes of red meatEach participant was randomized to consume 3 or 6 ounces of red meat as a part of the DASH dietary pattern for 12-weeks. | Other | Meat allocation in DASH intervention, Meat assignment in DASH intervention |
Primary outcome
Body weight
Time frame: Change in body weight from baseline to 3 months
Measured by bioelectrical impedance
Hand grip strength
Time frame: Change in strength from baseline to 3 months
Measured by a hand-held dynamometer
Glucose
Time frame: Change in glucose concentrations from baseline to 3 months
Measure serum glucose using colorimetry assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Derived from this study: PubMed 35287731Perry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cydne A Perry, PhD principal investigator
South Dakota State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet containing daily intakes of red meat in people with Obesity and Sarcopenia, run by South Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Change in body weight from baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.