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HypertensionGLOHNCT04230928

Giving a Low Carbohydrate Diet to Overcome Hypertension

A study testing Very low carbohydrate diet, Standard DPP-GLB diet and Standard DPP-GLB program modules in people with Hypertension and African Americans, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
What is being tested?
Very low carbohydrate diet, Standard DPP-GLB diet and Standard DPP-GLB program modules
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteUnited States
Study dates
5 Mar 2020to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Research Institute

    Dallas, Texas, 75210

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Very low carbohydrate diet, Standard DPP-GLB diet, Standard DPP-GLB program modules
Keywords
Hypertension, Low carbohydrate diet, African American race, Cardiovascular disease risk, Weight loss
Medical subject headings
Hypertension, Risk Reduction Behavior, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Very low carbohydrate dietOther

    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 dietOther

    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 modulesBehavioural

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

Study groups in NCT04230928
Study groupRoleWhat they receive
Standard GLB ControlPlacebo comparatorIndividuals 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.
Receives: Other: Standard DPP-GLB diet; Behavioral: Standard DPP-GLB program modules
VLC-GLB InterventionExperimentalIndividuals 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.
Receives: Other: Very low carbohydrate diet; Behavioral: Standard DPP-GLB program modules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline; 12 weeks; 10 months

  2. Dietary changes in carbohydrate intake

    Assess changes in diet using ASA24 online dietary recall

    Measured: Baseline; 12 weeks; 10 months

Secondary outcomes (8)

  1. Changes in Fasting blood glucose

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

    Measured: Baseline; 12 weeks; 10 months

  2. Changes in Hemoglobin A1C

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

    Measured: Baseline; 12 weeks; 10 months

  3. Changes in Cholesterol and lipoproteins

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

    Measured: Baseline; 12 weeks; 10 months

  4. Changes in % Body weight

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

    Measured: Baseline; 12 weeks; 10 months

  5. Changes in Body mass index (BMI)

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

    Measured: Baseline; 12 weeks; 10 months

  6. Dietary changes in fat intake

    Assess changes in diet using ASA24 online dietary recall

    Measured: Baseline; 12 weeks; 10 months

  7. Dietary changes in caloric intake

    Assess changes in diet using ASA24 online dietary recall

    Measured: Baseline; 12 weeks; 10 months

  8. Changes in Diastolic 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

    Measured: Baseline; 12 weeks; 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start5 Mar 2020
  3. Primary completion18 Nov 2021
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized 2-group study
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230928
Sponsor's protocol ID
019-268
Acronym
GLOH
Status last verified
Jan 2026
First submitted
10 Jan 2020
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlies results in publication

Publications

  • Gillum RF. Pathophysiology of hypertension in blacks and whites. A review of the basis of racial blood pressure differences. Hypertension. 1979 Sep-Oct;1(5):468-75. doi: 10.1161/01.hyp.1.5.468.

    PubMed 541040

  • 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.

    PubMed 29386200

  • Lackland DT. Racial differences in hypertension: implications for high blood pressure management. Am J Med Sci. 2014 Aug;348(2):135-8. doi: 10.1097/MAJ.0000000000000308.

    PubMed 24983758

  • Zhang D, Wang G, Zhang P, Fang J, Ayala C. Medical Expenditures Associated With Hypertension in the U.S., 2000-2013. Am J Prev Med. 2017 Dec;53(6S2):S164-S171. doi: 10.1016/j.amepre.2017.05.014.

    PubMed 29153117

  • Howard G, Prineas R, Moy C, Cushman M, Kellum M, Temple E, Graham A, Howard V. Racial and geographic differences in awareness, treatment, and control of hypertension: the REasons for Geographic And Racial Differences in Stroke study. Stroke. 2006 May;37(5):1171-8. doi: 10.1161/01.STR.0000217222.09978.ce. Epub 2006 Mar 23.

    PubMed 16556884

  • Lackland DT, Keil JE. Epidemiology of hypertension in African Americans. Semin Nephrol. 1996 Mar;16(2):63-70.

    PubMed 8668862

  • 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.

    PubMed 28807739

  • 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.

    PubMed 17686957

  • 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.

    PubMed 12489929

  • 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.

    PubMed 27327801

  • 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.

    PubMed 24717684

  • 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.

    PubMed 22704899

  • Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492.

    PubMed 20101008

  • 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.

    PubMed 12453955

  • Armstrong C; Joint National Committee. JNC8 guidelines for the management of hypertension in adults. Am Fam Physician. 2014 Oct 1;90(7):503-4. No abstract available.

    PubMed 25369633

Questions about this trial

What is this clinical trial studying?

A study testing Very low carbohydrate diet, Standard DPP-GLB diet and Standard DPP-GLB program modules in people with Hypertension and African Americans, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Systolic blood pressure (time frame: Baseline; 12 weeks; 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04230928, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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