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Giving a Low Carbohydrate Diet to Overcome Hypertension (GLOH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230928
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension African Americans Diet, Carbohydrate-Restricted Risk Reduction Behavior Other: Very low carbohydrate diet Other: Standard DPP-GLB diet Behavioral: Standard DPP-GLB program modules Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized 2-group study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study Comparing Dietary Approaches to Decrease Hypertension in a Lower Income, African American Population at Risk for Cardiovascular Disease
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 14, 2021

Resource links provided by the National Library of Medicine


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.
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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230928


Contacts
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Contact: Aisha H Montgomery, MD, MPH 2148653086 aisha.montgomery@bswhealth.org

Locations
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United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75210
Contact: Aisha H Montgomery, MD, MPH    214-865-3086    aisha.montgomery@bswhealth.org   
Contact: Heather Kitzman, PhD    214-865-3082    Heather.KitzmanCarmichael@BSWHealth.org   
Principal Investigator: Donald E Wesson, MD, MBA         
Sub-Investigator: Heather Kitzman, PhD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Aisha H Montgomery, MD, MPH Baylor Scott and White Health
Publications:
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. Review. Erratum in: Circulation. 2018 Mar 20;137(12 ):e493.

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT04230928    
Other Study ID Numbers: 019-268
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlies results in publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Data will be available within 6 months of outcome publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
Hypertension
Low carbohydrate diet
African American race
Cardiovascular disease risk
Weight loss
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases