Diabetes Reversal Online Program and Study (DROP Study)

NCT05572502 | Recruiting DMC

• 1 other identifier: Pro00066361
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.

Conditions

Type 2 Diabetes

Keywords

plant-based; vegan; diet; obesity

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin

  A1c will be measured before and after the study period

  12 weeks

Secondary Outcomes (4)

• body weight

  12 weeks

• total cholesterol

  12 weeks

• LDL cholesterol

  12 weeks

• medication usage

  12 weeks

Study Arms (1)

Vegan diet

EXPERIMENTAL

All participants will follow a low-fat vegan diet. There are no other study arms or control group.

Behavioral: plant-based diet

Interventions

plant-based diet BEHAVIORAL

For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study

Also known as: vegan diet

Vegan diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states
• Prior diagnosis of type 2 diabetes mellitus

You may not qualify if:

• Use of recreational drugs in the past 6 months
• Pregnancy or intention to become pregnant during the study period, as verified by self-report
• Unstable medical or psychiatric illness
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physician Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Related Publications (10)

• Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.

  PMID: 19351712 BACKGROUND

• Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

  PMID: 16873779 BACKGROUND

• Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a lowfat vegetarian diet among patients with cardiac disease. J Cardiopulmonary Rehabil 1992;12:423-31.

  BACKGROUND

• Barnard N, Scialli A, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. J Nutr Educ 2000;32:314-9.

  BACKGROUND

• Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35. doi: 10.1097/00008483-200407000-00004.

  PMID: 15286527 BACKGROUND

• Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.

  PMID: 19167953 BACKGROUND

• American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.

  PMID: 12778049 BACKGROUND

• Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.

  PMID: 7842153 BACKGROUND

• Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.

  BACKGROUND

• U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Diet, Plant-Based; Diet, Vegan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Vegetarian

Study Officials

• Neal Barnard, MD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VANITA RAHMAN, MD

CONTACT

2025277500; vrahman@pcrm.org

Roxanne Becker, MBChB

CONTACT

2022779760; rbecker@pcrm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Director

Model Details: single group, multiple replications

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 7, 2022
• Study Start: September 21, 2023
• Primary Completion: August 28, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (1)