Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR) diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular risk in individuals with type 2 diabetes and overweight/obesity.

Official Title
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Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity

Conditions
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Type 2 Diabetes Mellitus in Obese

Intervention / Treatment
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* Other: NDPR diet
* Other: USDA healthy eating diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 18-75 Type 2 diabetes mellitus diagnosed > 6 months prior to screening visit according to American Diabetes Association criteria HBA1c >7.5% but < 10% BMI >25 kg/m2 ; >23 kg/m2 for Asian subjects but < 45 kg/m2 Stable weight (variation < 5 kg within 6 months of screening visit) Ability to give informed consent Ability to follow verbal and written instructions in English Exclusion Criteria: Active cardiac issues: history of myocardial infarction within 3 months of screening visit, unstable angina pectoris, or Class III or Class IV congestive heart failure Persistent uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication) Active marijuana or intravenous drug use Recent weight loss (> 5 kg within 6 months of the screening visit) Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS) Celiac disease Malignancy treated with chemotherapy within the past 1 year Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines) Renal insufficiency (creatinine clearance < 30 ml/min) Transaminases > 2x above the normal range Pregnancy within 6 months of the screening visit Lactation History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling History of alcohol abuse within the past 5 years Vegetarian/Vegan diet Dairy Allergy/Intolerance Anemia, including iron deficient and megaloblastic Vitamin B12 deficiency Leber's disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NDPR diet<br>Subjects randomized to the nutrient dense plant rich (NDPR) diet will eat foods with high micronutrient density, and favorable glycemic index. The diet is low in saturated fat, high in fiber, and rich in phytochemicals. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include vegetables (30-70% of calories), fruits (15-20% of calories), Beans/Legumes (20-30% of calories), raw nuts and seeds (10-20% of calories), fish or fat-free dairy (twice weekly or less), poultry, eggs and oils (once weekly or less) and limited beef, cheese/milk, processed food and beef. | Other: NDPR diet<br>* nutrient rich plant based diert<br>|
| Experimental: USDA diet<br>Subjects randomized to the healthy U.S.-Style pattern diet will eat the types and proportions of foods Americans typically consume, but in nutrient-dense forms and appropriate amounts. It is designed to meet nutrient needs while not exceeding calorie requirements and while staying within limits for overconsumed dietary components. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include fruits, vegetables (dark green, red/orange, beans, and peas, starchy vegetables), grains (whole grains and refined grains), protein foods (meat, poultry, eggs, seafood, nuts, seeds and soy products), dairy, and oils. | Other: USDA healthy eating diet<br>* DASH diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | A1C and finger stick blood sugar levels | change at 1, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | change at 1, 3, 6, 9, 12 months | 
| body composition | DXA scan | change at 1,3,6,9, 12 months | 
| hepatic steatosis | MRspectroscopy | baseline, 1, 3, 6, 9, 12 months | 
| inflammatory markers | serum inflammatory markers | change at, 1, 3, 6, 9, 12 months | 
| quality of life | validated questionnaired | change at, 1, 3, 6, 9, 12 months |