An interventional study of Very low carbohydrate diet and Standard DPP-GLB diet in Hypertension, African Americans and Diet, Carbohydrate-Restricted, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Prevention
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Standard DPP-GLB diet · Behavioral: 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.
Other: Very low carbohydrate diet · Behavioral: Standard DPP-GLB program modules
Participants will learn to follow a very low carbohydrate diet in modified versions of GLB modules 2,3,5 \& 10. Participants will learn to track carbohydrate intake
Participants will learn to follow a very low fat, calorie-restricted diet and track fat grams and caloric intake in standard GLB modules 2,3,5, \& 10
Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
Changes in Systolic blood pressure
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
Time frame: Baseline; 12 weeks; 10 months
Dietary changes in carbohydrate intake
Assess changes in diet using ASA24 online dietary recall
Time frame: Baseline; 12 weeks; 10 months
Changes in Fasting blood glucose
Finger stick measure of blood glucose levels collected after 8-12 hours fasting
Time frame: Baseline; 12 weeks; 10 months
Changes in Hemoglobin A1C
Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting
Time frame: Baseline; 12 weeks; 10 months
Changes in Cholesterol and lipoproteins
Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting
Time frame: Baseline; 12 weeks; 10 months
Changes in % Body weight
Change in weight measured in lbs. with digital scale; % change calculated
Time frame: Baseline; 12 weeks; 10 months
Changes in Body mass index (BMI)
Change in calculated BMI based upon height (in.) with stadiometer \& weight (lbs.) with digital scale
Time frame: Baseline; 12 weeks; 10 months
Dietary changes in fat intake
Assess changes in diet using ASA24 online dietary recall
Time frame: Baseline; 12 weeks; 10 months
Dietary changes in caloric intake
Assess changes in diet using ASA24 online dietary recall
Time frame: Baseline; 12 weeks; 10 months
Changes in Diastolic blood pressure
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
Time frame: Baseline; 12 weeks; 10 months
Plan to share: Yes — All IPD that underlies results in publication
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be available within 6 months of outcome publication
Ran from Mar 2020 to primary completion in Nov 2021, 20 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 20 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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