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

Primary Purpose

Type 2 Diabetes Mellitus in Obese

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NDPR diet
USDA healthy eating diet
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus in Obese

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NDPR diet

USDA diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glycemic control
A1C and finger stick blood sugar levels

Secondary Outcome Measures

body weight
body composition
DXA scan
hepatic steatosis
MRspectroscopy
inflammatory markers
serum inflammatory markers
quality of life
validated questionnaired

Full Information

First Posted
November 20, 2016
Last Updated
January 13, 2020
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02977039
Brief Title
Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity
Official Title
Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no funding
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus in Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NDPR diet
Arm Type
Experimental
Arm Description
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.
Arm Title
USDA diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NDPR diet
Intervention Description
nutrient rich plant based diert
Intervention Type
Other
Intervention Name(s)
USDA healthy eating diet
Intervention Description
DASH diet
Primary Outcome Measure Information:
Title
Glycemic control
Description
A1C and finger stick blood sugar levels
Time Frame
change at 1, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
body weight
Time Frame
change at 1, 3, 6, 9, 12 months
Title
body composition
Description
DXA scan
Time Frame
change at 1,3,6,9, 12 months
Title
hepatic steatosis
Description
MRspectroscopy
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
inflammatory markers
Description
serum inflammatory markers
Time Frame
change at, 1, 3, 6, 9, 12 months
Title
quality of life
Description
validated questionnaired
Time Frame
change at, 1, 3, 6, 9, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share individual participant data with other researchers

Learn more about this trial

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

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