NCT02977039

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
2.9 years until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

November 20, 2016

Last Update Submit

January 13, 2020

Conditions

Type 2 Diabetes Mellitus in Obese

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    A1C and finger stick blood sugar levels

    change at 1, 3, 6, 9, 12 months

Secondary Outcomes (5)

  • body weight

    change at 1, 3, 6, 9, 12 months

  • body composition

    change at 1,3,6,9, 12 months

  • hepatic steatosis

    baseline, 1, 3, 6, 9, 12 months

  • inflammatory markers

    change at, 1, 3, 6, 9, 12 months

  • quality of life

    change at, 1, 3, 6, 9, 12 months

Study Arms (2)

NDPR diet

EXPERIMENTAL

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

USDA diet

EXPERIMENTAL

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

Interventions

NDPR dietOTHER

nutrient rich plant based diert

NDPR diet
USDA healthy eating dietOTHER

DASH diet

USDA diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2016

First Posted

November 30, 2016

Study Start

November 1, 2019

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

We will not share individual participant data with other researchers

Locations

US(1)