Giving a Low Carbohydrate Diet to Overcome Hypertension

Not Applicable

• Conditions: Hypertension; Risk Reduction Behavior; African Americans; Diet, Carbohydrate-Restricted
• Interventions: Other: Standard DPP-GLB diet; Other: Very low carbohydrate diet; Behavioral: Standard DPP-GLB program modules

• Registration Number: NCT04230928
• Lead Sponsor: Baylor Research Institute

Brief Summary

This study will test the preliminary efficacy of adding a very low carbohydrate dietary intervention to the evidence-based DPP-GLB on blood pressure reductions for lower-income AA men and women in a community-based clinic.

Detailed Description

This study will evaluate the effects of consuming a very low carbohydrate (VLC) diet in a sustainable community care setting, in addition to routine medical care, to African American (AA) with pre-hypertension, hypertension (stage 1-3), or cardiovascular disease risk factors. This study will also secondarily assess the feasibility of following a VLC diet in a low-income, AA population.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-03-05
• Primary Completion: 2021-11-18
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• 1. men and women aged ≥ 18 years
• 2. willingness to participate in a 10-month study
• 3. systolic blood pressure > 120 mm/Hg +/- diastolic blood pressure > 80 mm/Hg
• 4. African American race

Exclusion Criteria

• 1. diagnosed congestive heart failure
• 2. Hypertension stage 4 or higher (e.g., SBP >180 mm/Hg; DBP > 110 mm/Hg)
• 3. received or needing more than 3 anti-hypertensive medications
• 4. pregnant or planning to become pregnant
• 5. receiving or needing a heart transplant
• 6. Using injected long or short-acting insulin for diabetes treatment
• 7. not African American race
• 8. unable to speak and read English with fluency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard GLB Control	Standard DPP-GLB diet	Individuals will receive the standard Diabetes Prevention Program-Group Lifestyle Balance (GLB) program as outlined by the American Diabetes Association. This program will be taught at the Baylor Scott \& White Health and Wellness Center by trained research staff.
Standard GLB Control	Standard DPP-GLB program modules	Individuals will receive the standard Diabetes Prevention Program-Group Lifestyle Balance (GLB) program as outlined by the American Diabetes Association. This program will be taught at the Baylor Scott \& White Health and Wellness Center by trained research staff.
VLC-GLB Intervention	Very low carbohydrate diet	Individuals will receive a version of the DPP-GLB program in which 4 of the 12 modules will teach a very low carbohydrate diet instead of the standard. All other components of the DPP-GLB will follow the standard. This program will be taught at the Baylor Scott \& White Health and Wellness Center by trained research staff.
VLC-GLB Intervention	Standard DPP-GLB program modules	Individuals will receive a version of the DPP-GLB program in which 4 of the 12 modules will teach a very low carbohydrate diet instead of the standard. All other components of the DPP-GLB will follow the standard. This program will be taught at the Baylor Scott \& White Health and Wellness Center by trained research staff.

Primary Outcome Measures

Name	Time	Method
Changes in Systolic blood pressure	Baseline; 12 weeks; 10 months	Measure changes in both systolic and diastolic blood pressure using digital sphygmomanometer; NOTE: Only Systolic BP is primary outcome, diastolic change will be a secondary outcome measure
Dietary changes in carbohydrate intake	Baseline; 12 weeks; 10 months	Assess changes in diet using ASA24 online dietary recall

Secondary Outcome Measures

Name	Time	Method
Changes in Fasting blood glucose	Baseline; 12 weeks; 10 months	Finger stick measure of blood glucose levels collected after 8-12 hours fasting
Changes in Cholesterol and lipoproteins	Baseline; 12 weeks; 10 months	Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting
Changes in Diastolic blood pressure	Baseline; 12 weeks; 10 months	Measure changes in both systolic and diastolic blood pressure using digital sphygmomanometer; NOTE: Only Systolic BP is primary outcome, diastolic change will be a secondary outcome measure
Changes in Body mass index (BMI)	Baseline; 12 weeks; 10 months	Change in calculated BMI based upon height (in.) with stadiometer \& weight (lbs.) with digital scale
Changes in Hemoglobin A1C	Baseline; 12 weeks; 10 months	Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting
Dietary changes in caloric intake	Baseline; 12 weeks; 10 months	Assess changes in diet using ASA24 online dietary recall
Changes in % Body weight	Baseline; 12 weeks; 10 months	Change in weight measured in lbs. with digital scale; % change calculated
Dietary changes in fat intake	Baseline; 12 weeks; 10 months	Assess changes in diet using ASA24 online dietary recall

Trial Locations

Locations (1)

Baylor Research Institute; 🇺🇸 Dallas, Texas, United States