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The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on the management of type 1 diabetes in adults. The primary outcome measure of this study is insulin requirements (measured as the total daily dose (TDD) of insulin or basal and bolus insulin units injected per day). The study duration is 12 weeks.
Type 1 diabetes is a chronic autoimmune disorder characterized by loss of β-cell mass and function in the pancreas, leading to reduced secretion of insulin and hyperglycemia. The management of type 1 diabetes requires the administration of exogeneous insulin. Total daily dose (TDD) of insulin, a measure of the total amount of exogeneous insulin utilized per day, can be affected by multiple factors including insulin resistance, carbohydrate intake, body weight, and body composition. While the pathogenesis of type 1 diabetes and type 2 diabetes differ, a low-fat, plant-based diet has been shown to reduce insulin resistance, reduce body weight, improve body composition, and improve glycemic control in individuals with type 2 diabetes. A low-fat, plant-based diet has also been shown to improve β-cell function in individuals who are overweight. This finding is consistent with other research that shows that therapies that reduce body fat, or modify the distribution of body fat, improve β-cell function and glucose homeostasis. To date, a low-fat, plant-based diet has never been adequately tested in adults with type 1 diabetes. The purpose of this study is to compare the effects of low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on insulin requirements in adults with type 1 diabetes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-fat, vegan diet | Active Comparator | 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. |
|
| Portion-controlled diet | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Behavioral | Low-fat, plant-based diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Insulin Dose | A sum of basal and bolus insulin units (U) injected per day. An average from three (3) days (two (2) workdays and one (1) weekend day) will be utilized. | Change from week 0 to week 12 |
| Glycemic Control | Hemoglobin A1c (HbA1c), an index of glycemic control, will be utilized. | Change from week 0 to week 12 |
| Glycemic Variability | Glycemic variability will be assessed through use of a continuous glucose monitoring (CGM) system that will measure the concentration of glucose in the interstitial fluid. Participants will be instructed to wear a CGM (Dexcom g6 Platinum CGM System with an enhanced algorithm, software 505, Dexcom, Inc.) and record its readings at preset increments (after an overnight fast, before each meal, 2 hours after each meal, and before going to bed) daily. Participants will be prompted to submit CGM data to investigators on a weekly basis. | Change from week 0 to week 12 |
| 24-hour Carbohydrate to Insulin Ratio | Calculated as the total number of grams (g) of dietary carbohydrate to total units (U) of insulin administered. | Change from week 0 to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Change in body weight measured on a calibrated scale. | Change from week 0 to week 12 |
| Concentration of Plasma Lipids | Change in plasma cholesterol & triglycerides. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Use | Participants will be asked to report changes in their medication use. | Change from week 0 to week 12 |
| Diet Quality | Dietary intake will be assessed using 3-day dietary records. Participants will be instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Records will be analyzed using Nutrition Data System for Research software version 2018, developed by the Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN, US. |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hana Kahleova, MD, PhD | Physicians Committee for Responsible Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18175767 | Background | 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. | |
| 1659172 | Background | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Dietary intervention |
| Behavioral |
Portion-controlled diet (compliant with ADA guidelines) |
|
| Change from week 0 to week 12 |
| High-sensitivity C-reactive Protein (hs-CRP) | Implemented as a biomarker for absolute cardiovascular disease risk prediction. | Change from week 0 to week 12 |
| Tumor necrosis factor - α (TNF-α) | Implemented to assess levels of systemic inflammation. | Change from week 0 to week 12 |
| Interleukin (IL) - 1 (IL-1) and interleukin-6 (IL-6) | Implemented to assess levels of systemic inflammation. | Change from week 0 to week 12 |
| Food costs | Food costs will be assessed, using the U.S. Department of Agriculture Thrifty Food Plan, 2021, at baseline and 12 weeks. | 12 weeks |
| Insulin costs | Insulin costs will be assessed, using the Federal Supply Schedule (FSS) for insulin prices, at baseline and 12 weeks. | 12 weeks |
| Change from week 0 to week 12 |
| Diet Acceptability | The Food Acceptability Questionnaire (FAQ), a self-reported measure, will be implemented to assess the subjective responses (palatability; satisfaction; ease of preparation; financial feasibility; and perceived physical benefits) of participants to their baseline diets and the intervention diet. The FAQ has twelve (12) total questions. Eleven (11) of the questions are scored on a Likert scale (1-7) and one (1) unscored question (physical benefits) will prompt the participant to "check all that apply." A higher FAQ score corresponds with a more positive subjective response. | Change from week 0 to week 12 |
| 29382975 | Background | 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. |
| 12830019 | Background | 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. |
| 12900694 | Background | 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. |
| 11815483 | Background | 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. |
| 22673566 | Background | 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. |
| 12778049 | Background | 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. |
| 7842153 | Background | 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. |
| Background | Becker MH. The health belief model and personal health behavior. Health Educ Monogr. 1974;2:324-508. |
| Background | 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 |
| 42211763 | Derived | Smith R, Jayaraman A, McKay B, Chiavaroli L, Back S, Fischer I, Holubkov R, Barnard ND, Kahleova H. Environmental Footprint of a Low-Fat Vegan Diet in People With Type 1 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. Curr Dev Nutr. 2026 Apr 30;10(6):107709. doi: 10.1016/j.cdnut.2026.107709. eCollection 2026 Jun. |
| 41088465 | Derived | 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. |
| 40651893 | Derived | 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 Nov;35(11):104197. doi: 10.1016/j.numecd.2025.104197. Epub 2025 Jun 13. |
| 40474900 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |