Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity
NCT ID: NCT02977039
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2019-11-30
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease
NCT00229229
Reducing Energy Density by Different Methods to Decrease Energy Intake
NCT01470300
Effect of a Low Glycemic Index Diet on Breast Density
NCT01237938
Hospital Workplace Nutrition Study
NCT04222894
Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
NCT01729390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
NDPR diet
nutrient rich plant based diert
USDA 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.
USDA healthy eating diet
DASH diet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NDPR diet
nutrient rich plant based diert
USDA healthy eating diet
DASH diet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Martin Abrahamson
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016P000321
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.