Giving a Low Carbohydrate Diet to Overcome Hypertension
NCT ID: NCT04230928
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
61 participants
INTERVENTIONAL
2020-03-05
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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
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.
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 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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
Yes
Sponsors
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Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Aisha H Montgomery, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health
Locations
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Baylor Research Institute
Dallas, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
Lackland DT, Keil JE. Epidemiology of hypertension in African Americans. Semin Nephrol. 1996 Mar;16(2):63-70.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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019-268
Identifier Type: -
Identifier Source: org_study_id