Giving a Low Carbohydrate Diet to Overcome Hypertension

Hypertension Clinical Trial

— GLOH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04230928
• Other study ID #: 019-268
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2021
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: June 30, 2022
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Baylor Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (15)

Armstrong C; Joint National Committee. JNC8 guidelines for the management of hypertension in adults. Am Fam Physician. 2014 Oct 1;90(7):503-4. — View Citation

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. — View Citation

Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. — View Citation

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. — View Citation

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. Epub 2006 Mar 23. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Rehm CD, Peñalvo 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Aug 8. Review. — View Citation

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. Erratum in: JAMA Intern Med. 2015 Mar;175(3):470. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dietary changes in carbohydrate intake	Assess changes in diet using ASA24 online dietary recall	Baseline; 12 weeks; 10 months
Secondary	Changes in Fasting blood glucose	Finger stick measure of blood glucose levels collected after 8-12 hours fasting	Baseline; 12 weeks; 10 months
Secondary	Changes in Hemoglobin A1C	Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting	Baseline; 12 weeks; 10 months
Secondary	Changes in Cholesterol and lipoproteins	Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting	Baseline; 12 weeks; 10 months
Secondary	Changes in % Body weight	Change in weight measured in lbs. with digital scale; % change calculated	Baseline; 12 weeks; 10 months
Secondary	Changes in Body mass index (BMI)	Change in calculated BMI based upon height (in.) with stadiometer & weight (lbs.) with digital scale	Baseline; 12 weeks; 10 months
Secondary	Dietary changes in fat intake	Assess changes in diet using ASA24 online dietary recall	Baseline; 12 weeks; 10 months
Secondary	Dietary changes in caloric intake	Assess changes in diet using ASA24 online dietary recall	Baseline; 12 weeks; 10 months
Secondary	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	Baseline; 12 weeks; 10 months