Diabetes Mellitus, Type 1T1DNCT04944316
Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes
A study testing Dietary intervention in people with Diabetes Mellitus, Type 1, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 9 Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Men and women ≥ 18 years of age
- Stable insulin regimen for past 3 months
Who cannot join
- Type 2 or gestational diabetes
- Body mass index ≥ 40 kg/m2
- HbA1c ≥ 12.0%
- Smoking or drug abuse during the past six months
- 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
- Unstable medical or psychiatric illness
Show all 11Show fewer
- Already following a low-fat vegan diet
- Pregnant or breastfeeding, or plans of pregnancy within the study period
- Lack of English fluency
- Unable or unwilling to participate in all components of the study
- Evidence of an eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016
About this study
Official title: Physicians Committee for Responsible Medicine - a Randomized, Controlled Study of the Effect of a Low-fat, Plant-based Diet on Insulin Requirements in Individuals with Type 1 Diabetes
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Dietary intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
Low-fat, plant-based diet
Dietary interventionBehavioural
Portion-controlled diet (compliant with ADA guidelines)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dietary intervention |
| 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. Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from week 0 to week 12
Glycemic Control
Hemoglobin A1c (HbA1c), an index of glycemic control, will be utilized.
Measured: 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.
Measured: 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.
Measured: Change from week 0 to week 12
Secondary outcomes (7)
Body Weight
Change in body weight measured on a calibrated scale.
Measured: Change from week 0 to week 12
Concentration of Plasma Lipids
Change in plasma cholesterol \& triglycerides.
Measured: Change from week 0 to week 12
High-sensitivity C-reactive Protein (hs-CRP)
Implemented as a biomarker for absolute cardiovascular disease risk prediction.
Measured: Change from week 0 to week 12
Tumor necrosis factor - α (TNF-α)
Implemented to assess levels of systemic inflammation.
Measured: Change from week 0 to week 12
Interleukin (IL) - 1 (IL-1) and interleukin-6 (IL-6)
Implemented to assess levels of systemic inflammation.
Measured: 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.
Measured: 12 weeks
Insulin costs
Insulin costs will be assessed, using the Federal Supply Schedule (FSS) for insulin prices, at baseline and 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start19 Jan 2022
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hana Kahleova, MD, PhD, Principal investigator, Physicians Committee for Responsible Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944316
- Sponsor's protocol ID
- Pro00048903
- Acronym
- T1D
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18175767Anderson 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.
PubMed 1659172American 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.
PubMed 29382975Pastors 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.
PubMed 12830019Craig 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.
PubMed 12900694Mari 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.
PubMed 11815483Kahleova 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.
PubMed 22673566American 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.
PubMed 12778049Barnard 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.
PubMed 7842153Becker 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
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.
PubMed 42211763Kahleova 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.
PubMed 41088465Kahleova 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.
PubMed 40651893Kahleova 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.
PubMed 40474900
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physicians Committee for Responsible Medicine - a Randomized, Controlled Study of the Effect of a Low-fat, Plant-based Diet on Insulin Requirements in Individuals with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04944316
- Acronym / sponsor ID
- T1D / Pro00048903
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fat, vegan diet | Active comparator | Behavioral: Dietary interventionFor 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 | Behavioral: Dietary interventionFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes
- Men and women ≥ 18 years of age
- Stable insulin regimen for past 3 months
Key exclusion criteria (11 listed)
- Type 2 or gestational diabetes
- Body mass index ≥ 40 kg/m2
- HbA1c ≥ 12.0%
- Smoking or drug abuse during the past six months
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionLow-fat, plant-based diet | Behavioural | Low-fat, vegan diet |
| Dietary interventionPortion-controlled diet (compliant with ADA guidelines) | Behavioural | Portion-controlled diet |
Primary outcome
Total Insulin Dose
Time frame: Change from week 0 to week 12
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.
Glycemic Control
Time frame: Change from week 0 to week 12
Hemoglobin A1c (HbA1c), an index of glycemic control, will be utilized.
Glycemic Variability
Time frame: Change from week 0 to week 12
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.
24-hour Carbohydrate to Insulin Ratio
Time frame: Change from week 0 to week 12
Calculated as the total number of grams (g) of dietary carbohydrate to total units (U) of insulin administered.
7 secondary outcomes
Body Weight
Time frame: Change from week 0 to week 12
Concentration of Plasma Lipids
Time frame: Change from week 0 to week 12
High-sensitivity C-reactive Protein (hs-CRP)
Time frame: Change from week 0 to week 12
Tumor necrosis factor - α (TNF-α)
Time frame: Change from week 0 to week 12
Interleukin (IL) - 1 (IL-1) and interleukin-6 (IL-6)
Time frame: Change from week 0 to week 12
Food costs
Time frame: 12 weeks
Insulin costs
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 18175767Riccardi 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.
- Background: PubMed 1659172Anderson 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.
- Background: PubMed 29382975American 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.
- Background: PubMed 12830019Pastors 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 11815483Mari 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.
- Background: PubMed 22673566Kahleova 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.
- Background: PubMed 12778049American 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.
- Background: PubMed 7842153Barnard 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.
- BackgroundBecker MH. The health belief model and personal health behavior. Health Educ Monogr. 1974;2:324-508.
- BackgroundBarnard 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
- Derived from this study: PubMed 42211763Smith 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Kahleova, MD, PhD principal investigator
Physicians Committee for Responsible Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Diabetes Mellitus, Type 1, run by Physicians Committee for Responsible Medicine 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 3 inclusion and 11 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 27 Sep 2024. 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. 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?
Total Insulin Dose (time frame: Change from week 0 to week 12). The study lists 4 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 NCT04944316, 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 27 Sep 2024.