Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure (DASHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113291
Recruitment Status : Withdrawn (Insufficient funding)
First Posted : October 2, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure With Preserved Ejection Fraction Other: DASH Diet Other: Usual diet Not Applicable

Detailed Description:
This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: DASH diet group
Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.
Other: DASH Diet
12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). Participants will prepare their own breakfast from a menu.The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.
Other Name: Dietary Approaches to Stop Hypertension

Active Comparator: Attention Control Group
Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study.
Other: Usual diet
12 weeks usual diet <2300 mg Na/day




Primary Outcome Measures :
  1. Number of enrolled participants per week [ Time Frame: Up to week 12 ]
  2. Proportion of participants that adhere to the to intervention [ Time Frame: Up to week 12 ]
  3. Number participants that were retained in the trial [ Time Frame: Up to week 12 ]

Secondary Outcome Measures :
  1. Proportion of participants that adhere to the diet [ Time Frame: Up to week 12 ]

Other Outcome Measures:
  1. Weight [ Time Frame: Baseline ]
    Weight (kilograms)

  2. Weight [ Time Frame: After intervention, Week 12 ]
    Weight (kilograms)

  3. Waist circumference [ Time Frame: Baseline ]
    Waist circumference (cm)

  4. Waist circumference [ Time Frame: After intervention, Week 12 ]
    Waist circumference (cm)

  5. Body mass Index (BMI) [ Time Frame: Baseline ]
  6. Body mass Index (BMI) [ Time Frame: After intervention, Week 12 ]
  7. Systolic Blood Pressure [ Time Frame: Baseline ]
  8. Systolic Blood Pressure [ Time Frame: After intervention, Week 12 ]
  9. Diastolic Blood Pressure [ Time Frame: Baseline ]
  10. Diastolic Blood Pressure [ Time Frame: After intervention, Week 12 ]
  11. Total Cholesterol [ Time Frame: Baseline ]
  12. LDL Cholesterol [ Time Frame: Baseline ]
  13. HDL Cholesterol [ Time Frame: Baseline ]
  14. serum creatinine [ Time Frame: Baseline ]
  15. Total Cholesterol [ Time Frame: After intervention, Week 12 ]
  16. LDL Cholesterol [ Time Frame: After intervention, Week 12 ]
  17. HDL Cholesterol [ Time Frame: After intervention, Week 12 ]
  18. Serum creatinine [ Time Frame: After intervention, Week 12 ]
  19. Left Ventricle mass [ Time Frame: Baseline ]
    Doppler-echocardiograms

  20. Left Ventricle mass [ Time Frame: After intervention, Week 12 ]
    Doppler-echocardiograms

  21. Left atrial volume [ Time Frame: Baseline ]
    Doppler-echocardiograms

  22. Left atrial volume [ Time Frame: After intervention, Week 12 ]
    Doppler-echocardiograms

  23. Doppler echocardiogram velocity ratio [ Time Frame: Baseline ]
  24. Doppler echocardiogram velocity ratio [ Time Frame: After intervention, Week 12 ]
  25. CRP [ Time Frame: Baseline ]
    Inflammatory marker

  26. IL6 [ Time Frame: Baseline ]
    Inflammatory marker

  27. TNF alpha [ Time Frame: Baseline ]
    Inflammatory marker

  28. CRP [ Time Frame: After intervention, Week 12 ]
    Inflammatory marker

  29. IL6 [ Time Frame: After intervention, Week 12 ]
    Inflammatory marker

  30. TNF alpha [ Time Frame: After intervention, Week 12 ]
    Inflammatory marker

  31. 6- minute walk test [ Time Frame: Baseline ]
    Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender.

  32. 6- minute walk test [ Time Frame: After intervention, Week 12 ]
    Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender.

  33. Plasma nitrate [ Time Frame: Baseline ]
  34. Plasma nitrate [ Time Frame: After intervention, Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants will have an education level of less than college as a surrogate marker of LSES.

Exclusion Criteria:

  • Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
  • poorly controlled diabetes mellitus ( HBA 1c >9%)
  • or uncontrolled hypertension ( SBP>180, DBP>110)
  • cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
  • chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
  • body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35

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): NCT04113291


Locations
Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Claudia Campos, MD Wake Forest University Health Sciences
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04113291    
Other Study ID Numbers: DASHF-PRE
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
DASH Diet
Low socioeconomic status
HFPEF
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases