Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes
NCT ID: NCT04944316
Last Updated: 2024-09-27
Study Results
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Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-01-19
2022-11-09
Brief Summary
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Detailed Description
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Using a parallel group design, participants with type 1 diabetes will be randomly assigned to follow a low-fat, plant-based diet or a portion-controlled diet (compliant with current ADA guidelines) for 12 weeks. The principal dependent measures of this study are TDD of insulin, hemoglobin A1c (HbA1c), interstitial fluid glucose levels, and 24-hour carbohydrate: insulin ratio. Secondary and tertiary dependent measures include inflammatory biomarkers, blood lipids, body weight, diet quality, diet acceptability, and medication use.
The investigators hypothesize that both the low-fat, plant-based dietary intervention and the portion-controlled dietary intervention will elicit changes in insulin requirements, HbA1c, variability in interstitial glucose levels, insulin sensitivity, and body weight in participants with type 1 diabetes. The investigators further hypothesize that the low-fat, plant-based dietary intervention will confer a more substantial effect on changes in insulin requirements, HbA1c, insulin sensitivity, variability in interstitial glucose levels, and body weight in participants with type 1 diabetes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low-fat, vegan diet
For a 12-week period, participants will be asked to follow a low-fat, vegan diet which consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. In choosing grain products and starchy vegetables (e.g., bread, potatoes), participants will be encouraged to select those retaining their natural fiber and having a glycemic index \<70, using tables standardized to a value of 100 for glucose.
Dietary intervention
Low-fat, plant-based diet
Portion-controlled diet
For a 12-week period, participants will be asked to follow a portion-controlled diet that is compliant with American Diabetes Association (ADA) guidelines. This diet will include individualized diet plans that reduce daily energy intake by 500-1,000 kcal for overweight (body mass index \> 25 kg/m2) participants and keep carbohydrate intake reasonably stable over time. It will derive 15-20% from protein, \<7% saturated fat, 60-70% carbohydrate and monounsaturated fats and ≤200 mg/day of cholesterol/day.
Dietary intervention
Portion-controlled diet (compliant with ADA guidelines)
Interventions
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Dietary intervention
Low-fat, plant-based diet
Dietary intervention
Portion-controlled diet (compliant with ADA guidelines)
Eligibility Criteria
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Inclusion Criteria
2. Men and women ≥ 18 years of age
3. Stable insulin regimen for past 3 months
Exclusion Criteria
2. Body mass index ≥ 40 kg/m2
3. HbA1c ≥ 12.0%
4. Smoking or drug abuse during the past six months
5. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
6. Unstable medical or psychiatric illness
7. Already following a low-fat vegan diet
8. Pregnant or breastfeeding, or plans of pregnancy within the study period
9. Lack of English fluency
10. Unable or unwilling to participate in all components of the study
11. Evidence of an eating disorder
18 Years
ALL
Yes
Sponsors
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Physicians Committee for Responsible Medicine
OTHER
Responsible Party
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Principal Investigators
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Hana Kahleova, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Physicians Committee for Responsible Medicine
Locations
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Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, United States
Countries
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References
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Riccardi G, Rivellese AA, Giacco R. Role of glycemic index and glycemic load in the healthy state, in prediabetes, and in diabetes. Am J Clin Nutr. 2008 Jan;87(1):269S-274S. doi: 10.1093/ajcn/87.1.269S.
Anderson JW, Zeigler JA, Deakins DA, Floore TL, Dillon DW, Wood CL, Oeltgen PR, Whitley RJ. Metabolic effects of high-carbohydrate, high-fiber diets for insulin-dependent diabetic individuals. Am J Clin Nutr. 1991 Nov;54(5):936-43. doi: 10.1093/ajcn/54.5.936.
American Diabetes Association. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. Clin Diabetes. 2018 Jan;36(1):14-37. doi: 10.2337/cd17-0119. No abstract available.
Pastors JG, Franz MJ, Warshaw H, Daly A, Arnold MS. How effective is medical nutrition therapy in diabetes care? J Am Diet Assoc. 2003 Jul;103(7):827-31. doi: 10.1016/s0002-8223(03)00466-8. No abstract available.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
Mari A, Tura A, Gastaldelli A, Ferrannini E. Assessing insulin secretion by modeling in multiple-meal tests: role of potentiation. Diabetes. 2002 Feb;51 Suppl 1:S221-6. doi: 10.2337/diabetes.51.2007.s221.
Kahleova H, Mari A, Nofrate V, Matoulek M, Kazdova L, Hill M, Pelikanova T. Improvement in beta-cell function after diet-induced weight loss is associated with decrease in pancreatic polypeptide in subjects with type 2 diabetes. J Diabetes Complications. 2012 Sep-Oct;26(5):442-9. doi: 10.1016/j.jdiacomp.2012.05.003. Epub 2012 Jun 4.
American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.
Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.
Becker MH. The health belief model and personal health behavior. Health Educ Monogr. 1974;2:324-508.
Barnard N, Scialli AR, Bertron P, Hurlock D, Edmonds K. Acceptability of a Therapeutic Low-Fat, Vegan Diet in Premenopausal Women. J Nutr Educ. 2000;32(6):314-319. doi:10.1016/S0022-3182(00)70590-5
Kahleova H, Maracine C, Znayenko-Miller T, Kuo S, Herman WH, Holubkov R, Barnard ND. Can a vegan diet help people with type 1 diabetes save on insulin? A secondary analysis of a 12-Week randomized clinical trial. BMC Nutr. 2025 Oct 14;11(1):188. doi: 10.1186/s40795-025-01175-2.
Kahleova H, Himmelfarb J, Znayenko-Miller T, Jayaraman A, Chiavaroli L, Holubkov R, Barnard ND. Vegan diet, processed foods, and type 1 diabetes: A secondary analysis of a randomized clinical trial. Nutr Metab Cardiovasc Dis. 2025 Jun 13:104197. doi: 10.1016/j.numecd.2025.104197. Online ahead of print.
Kahleova H, Fischer I, Smith R, Himmelfarb J, Znayenko-Miller T, Holubkov R, Barnard ND. Plant-based dietary index and body weight in people with type 1 diabetes: a secondary analysis of a randomized clinical trial. Front Nutr. 2025 May 22;12:1605769. doi: 10.3389/fnut.2025.1605769. eCollection 2025.
Other Identifiers
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Pro00048903
Identifier Type: -
Identifier Source: org_study_id
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