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The CARING Study: Creating and Restoring Health Through Nutrition Guidance

NCT05795439 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Blue Cross Blue Shield

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Physicians Committee for Responsible Medicine

    lead OTHER

Principal Investigators

  • Neal Barnard, MD · Physicians Committee for Responsible Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795439 on ClinicalTrials.gov