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

Not Applicable

Withdrawn

• Conditions: Type 2 Diabetes Mellitus in Obese
• Interventions: Other: NDPR diet; Other: USDA healthy eating diet

• Registration Number: NCT02977039
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-27
• Study First Posted: 2016-11-30
• Study Start: 2019-11
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Men and women ages 18-75
2. Type 2 diabetes mellitus diagnosed > 6 months prior to screening visit according to American Diabetes Association criteria
3. HBA1c >7.5% but < 10%
4. BMI >25 kg/m2 ; >23 kg/m2 for Asian subjects but < 45 kg/m2
5. Stable weight (variation < 5 kg within 6 months of screening visit)
6. Ability to give informed consent
7. Ability to follow verbal and written instructions in English

Exclusion Criteria

1. 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
2. Persistent uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication)
3. Active marijuana or intravenous drug use
4. Recent weight loss (> 5 kg within 6 months of the screening visit)
5. Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
6. Celiac disease
7. Malignancy treated with chemotherapy within the past 1 year
8. Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
9. Renal insufficiency (creatinine clearance < 30 ml/min)
10. Transaminases > 2x above the normal range
11. Pregnancy within 6 months of the screening visit
12. Lactation
13. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling
14. History of alcohol abuse within the past 5 years
15. Vegetarian/Vegan diet
16. Dairy Allergy/Intolerance
17. Anemia, including iron deficient and megaloblastic
18. Vitamin B12 deficiency
19. Leber's disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NDPR diet	NDPR diet	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.
USDA diet	USDA healthy eating diet	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.

Primary Outcome Measures

Name	Time	Method
Glycemic control	change at 1, 3, 6, 9, 12 months	A1C and finger stick blood sugar levels

Secondary Outcome Measures

Name	Time	Method
body composition	change at 1,3,6,9, 12 months	DXA scan
quality of life	change at, 1, 3, 6, 9, 12 months	validated questionnaired
hepatic steatosis	baseline, 1, 3, 6, 9, 12 months	MRspectroscopy
body weight	change at 1, 3, 6, 9, 12 months
inflammatory markers	change at, 1, 3, 6, 9, 12 months	serum inflammatory markers

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States