Clinical trial NCT04230928: Giving a Low Carbohydrate Diet to Overcome Hypertension
Official title: A Pilot Study Comparing Dietary Approaches to Decrease Hypertension in a Lower Income, African American Population at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
African Americans
Diet, Carbohydrate-Restricted
Risk Reduction Behavior
Keywords: Hypertension
Low carbohydrate diet
African American race
Cardiovascular disease risk
Weight loss
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized 2-group study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Systolic blood pressure
timeFrame: Baseline; 12 weeks; 10 months
measure: Dietary changes in carbohydrate intake
timeFrame: Baseline; 12 weeks; 10 months
Secondary outcomes:
measure: Changes in Fasting blood glucose
timeFrame: Baseline; 12 weeks; 10 months
measure: Changes in Hemoglobin A1C
timeFrame: Baseline; 12 weeks; 10 months
measure: Changes in Cholesterol and lipoproteins
timeFrame: Baseline; 12 weeks; 10 months
measure: Changes in % Body weight
timeFrame: Baseline; 12 weeks; 10 months
measure: Changes in Body mass index (BMI)
timeFrame: Baseline; 12 weeks; 10 months
measure: Dietary changes in fat intake
timeFrame: Baseline; 12 weeks; 10 months
measure: Dietary changes in caloric intake
timeFrame: Baseline; 12 weeks; 10 months
measure: Changes in Diastolic blood pressure
timeFrame: Baseline; 12 weeks; 10 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Aisha H Montgomery, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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