Recruiting

Nutrition Guidance

Sponsor:

Physicians Committee for Responsible Medicine

Code:

NCT05795439

Conditions

Type2diabetes

Type 2 Diabetes Treated With Insulin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Low-fat, vegan diet

Study Details

Brief summary:

The CARING study assesses the health benefits of nutrition education for Blue Cross Blue Shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.

Conditions

Type2diabetes

Type 2 Diabetes Treated With Insulin

Study ID

NCT05795439

Start date

Jul 11, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
2. Male or female
3. Age at least 18 years
4. Have a diagnosis of type 2 diabetes
5. Ability and willingness to participate in all components of the study, including:

1. Following a plant-based diet for the initial 16 weeks of the study;
2. Attending weekly online classes for the initial 16 weeks of the study; and
3. Keeping physical activity level consistent throughout the initial 16 weeks of the study.

Exclusion Criteria:

1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
2. Smoking during the past six months
3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
4. Current or unresolved past drug abuse
5. Recently gave birth, pregnant, or plans to become pregnant before or during the study period
6. Unstable medical or psychiatric status
7. Cancer diagnosis
8. Chronic kidney disease, stage 4 or 5
9. Evidence of an eating disorder
10. Lack of English fluency
11. Bariatric surgery in the last 6 months
12. Dementia
13. Institutional custodial care
14. End of life
15. Palliative Care
16. Actively engaged in specific BCBSM diabetes programs and case management programs

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

The Intervention group arm of participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks.

no intervention: Control Group

The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Interventions

Low-fat, vegan diet

The intervention diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Participants will also be guided to favor foods with a low glycemic index. Animal products and added oils will be excluded. The diet is designed to derive approximately 10% of energy from fat, approximately 10-15% of energy from protein, and the remainder from mostly complex carbohydrates. The diet will also provide approximately 40 g of fiber per day.

Primary outcome measure

  • Medical Utilization [ Time Frame: 16 weeks, 1 year, and 2 years ]
  • Body Weight [ Time Frame: 16 weeks, 1 year, and 2 years ]
  • Plasma Lipid Concentrations [ Time Frame: 16 weeks, Every 6 months during the 2-year follow-up period ]
  • HbA1C [ Time Frame: 16 weeks, Every 6 months during the 2-year follow-up period ]

Central Contacts and Locations

Central contacts

Locations

Physicians Committee for Responsible Medicine

Recruiting

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

Contacts

Physicians CFR Medicine

2025277363ajayaraman@pcrm.org

More Information

Sponsor

Physicians Committee for Responsible Medicine

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Diabetes
  • Type2
  • Insulin
  • A1C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Physicians Committee for Responsible Medicine on 2026-04-13.