Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes (T1D)
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion criteria:
- Type 1 diabetes
- Men and women ≥ 18 years of age
- Stable insulin regimen for past 3 months
Exclusion criteria:
- 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
- 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
Sites / Locations
- Physicians Committee for Responsible MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Low-fat, vegan diet
Portion-controlled 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.
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.