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Completed

NCT Number: NCT04230928

Giving a Low Carbohydrate Diet to Overcome Hypertension

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.

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Key information

Conditions

Hypertension African Americans Behavior Body Weight Body Weight Changes Cardiovascular Diseases Diet, Carbohydrate-Restricted Pathological Conditions, Signs and Symptoms Risk Reduction Behavior Signs and Symptoms Vascular Diseases Weight Loss

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Research Institute

Dallas, Texas, 75210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low carbohydrate diet

Other

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

Standard DPP-GLB diet

Other

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

Standard DPP-GLB program modules

Behavioral

Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22

Primary outcomes

  1. Changes in Systolic blood pressure

    Time frame: 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

  2. Dietary changes in carbohydrate intake

    Time frame: Baseline; 12 weeks; 10 months

    Assess changes in diet using ASA24 online dietary recall

Secondary outcomes

  1. Changes in Fasting blood glucose

    Time frame: Baseline; 12 weeks; 10 months

    Finger stick measure of blood glucose levels collected after 8-12 hours fasting

  2. Changes in Hemoglobin A1C

    Time frame: Baseline; 12 weeks; 10 months

    Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting

  3. Changes in Cholesterol and lipoproteins

    Time frame: Baseline; 12 weeks; 10 months

    Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting

  4. Changes in % Body weight

    Time frame: Baseline; 12 weeks; 10 months

    Change in weight measured in lbs. with digital scale; % change calculated

  5. Changes in Body mass index (BMI)

    Time frame: Baseline; 12 weeks; 10 months

    Change in calculated BMI based upon height (in.) with stadiometer & weight (lbs.) with digital scale

  6. Dietary changes in fat intake

    Time frame: Baseline; 12 weeks; 10 months

    Assess changes in diet using ASA24 online dietary recall

  7. Dietary changes in caloric intake

    Time frame: Baseline; 12 weeks; 10 months

    Assess changes in diet using ASA24 online dietary recall

  8. Changes in Diastolic blood pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

A Pilot Study Comparing Dietary Approaches to Decrease Hypertension in a Lower Income, African American Population at Risk for Cardiovascular Disease

Acronym: GLOH

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jan 18, 2020
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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