Giving a Low Carbohydrate Diet to Overcome Hypertension

NCT04230928 | Completed

• 1 other identifier: 019-268
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

African Americans; Diet, Carbohydrate-Restricted; Risk Reduction Behavior; Hypertension

Keywords

Hypertension; Low carbohydrate diet; African American race; Cardiovascular disease risk; Weight loss

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline; 12 weeks; 10 months

• Dietary changes in carbohydrate intake

  Assess changes in diet using ASA24 online dietary recall

  Baseline; 12 weeks; 10 months

Secondary Outcomes (8)

• Changes in Fasting blood glucose

  Baseline; 12 weeks; 10 months

• Changes in Hemoglobin A1C

  Baseline; 12 weeks; 10 months

• Changes in Cholesterol and lipoproteins

  Baseline; 12 weeks; 10 months

• Changes in % Body weight

  Baseline; 12 weeks; 10 months

• Changes in Body mass index (BMI)

  Baseline; 12 weeks; 10 months

Study Arms (2)

Standard GLB Control

PLACEBO COMPARATOR

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

VLC-GLB Intervention

EXPERIMENTAL

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

Interventions

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

VLC-GLB Intervention

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 GLB Control

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

Standard GLB Control; VLC-GLB Intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) men and women aged ≥ 18 years
• \) willingness to participate in a 10-month study
• \) systolic blood pressure \> 120 mm/Hg +/- diastolic blood pressure \> 80 mm/Hg
• \) African American race

You may not qualify if:

• \) diagnosed congestive heart failure
• \) Hypertension stage 4 or higher (e.g., SBP \>180 mm/Hg; DBP \> 110 mm/Hg)
• \) received or needing more than 3 anti-hypertensive medications
• \) pregnant or planning to become pregnant
• \) receiving or needing a heart transplant
• \) Using injected long or short-acting insulin for diabetes treatment
• \) not African American race
• \) unable to speak and read English with fluency

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75210, United States

Location

Related Publications (15)

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  PMID: 541040 BACKGROUND

• 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, Jimenez 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. No abstract available.

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  PMID: 29153117 BACKGROUND

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  PMID: 16556884 BACKGROUND

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  PMID: 8668862 BACKGROUND

• Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.

  PMID: 28807739 BACKGROUND

• Tiwari S, Riazi S, Ecelbarger CA. Insulin's impact on renal sodium transport and blood pressure in health, obesity, and diabetes. Am J Physiol Renal Physiol. 2007 Oct;293(4):F974-84. doi: 10.1152/ajprenal.00149.2007. Epub 2007 Aug 8.

  PMID: 17686957 BACKGROUND

• Meckling KA, Gauthier M, Grubb R, Sanford J. Effects of a hypocaloric, low-carbohydrate diet on weight loss, blood lipids, blood pressure, glucose tolerance, and body composition in free-living overweight women. Can J Physiol Pharmacol. 2002 Nov;80(11):1095-105. doi: 10.1139/y02-140.

  PMID: 12489929 BACKGROUND

• Rehm CD, Penalvo JL, Afshin A, Mozaffarian D. Dietary Intake Among US Adults, 1999-2012. JAMA. 2016 Jun 21;315(23):2542-53. doi: 10.1001/jama.2016.7491.

  PMID: 27327801 BACKGROUND

• Saslow LR, Kim S, Daubenmier JJ, Moskowitz JT, Phinney SD, Goldman V, Murphy EJ, Cox RM, Moran P, Hecht FM. A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. PLoS One. 2014 Apr 9;9(4):e91027. doi: 10.1371/journal.pone.0091027. eCollection 2014.

  PMID: 24717684 BACKGROUND

• Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available.

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• Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.

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  PMID: 25369633 BACKGROUND

MeSH Terms

Conditions

Hypertension; Risk Reduction Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aisha H Montgomery, MD, MPH

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized 2-group study

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: March 5, 2020
• Primary Completion: November 18, 2021
• Study Completion: June 30, 2023
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of outcome publication

Locations

US (1)