Giving a Low Carbohydrate Diet to Overcome Hypertension (GLOH)

December 16, 2021 updated by: Baylor Research Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75210
        • Baylor Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Standard GLB Control
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
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
Behavioral: Standard DPP-GLB program modules
Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
EXPERIMENTAL: VLC-GLB Intervention
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.
Behavioral: Standard DPP-GLB program modules
Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
Other: Very low carbohydrate diet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline; 12 weeks; 10 months
Dietary changes in carbohydrate intake
Time Frame: Baseline; 12 weeks; 10 months
Assess changes in diet using ASA24 online dietary recall
Baseline; 12 weeks; 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline; 12 weeks; 10 months
Changes in Hemoglobin A1C
Time Frame: Baseline; 12 weeks; 10 months
Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting
Baseline; 12 weeks; 10 months
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
Baseline; 12 weeks; 10 months
Changes in % Body weight
Time Frame: Baseline; 12 weeks; 10 months
Change in weight measured in lbs. with digital scale; % change calculated
Baseline; 12 weeks; 10 months
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
Baseline; 12 weeks; 10 months
Dietary changes in fat intake
Time Frame: Baseline; 12 weeks; 10 months
Assess changes in diet using ASA24 online dietary recall
Baseline; 12 weeks; 10 months
Dietary changes in caloric intake
Time Frame: Baseline; 12 weeks; 10 months
Assess changes in diet using ASA24 online dietary recall
Baseline; 12 weeks; 10 months
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
Baseline; 12 weeks; 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Aisha H Montgomery, MD, MPH, Baylor Scott and White Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2020

Primary Completion (ACTUAL)

November 18, 2021

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019-268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlies results in publication

IPD Sharing Time Frame

Data will be available within 6 months of outcome publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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