Glutathione-rich Foods for Type 2 Diabetes

NCT ID: NCT04386187

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-04-02

Brief Summary

The purpose of this research study is to find out whether certain plant-based foods may be beneficial for individuals with type 2 diabetes. To meet the goal, study participants will be fed known amounts of foods and nutrients. Before and after participants have eaten the food, they will self-measure height, weight, and waist circumference and study staff will administer questionnaires. Blood samples will be taken at a local lab to measure blood sugar and blood lipids.All study appointments will be conducted online.

Detailed Description

This research study is a randomized, controlled trial that will evaluate whether diet and nutrition education on, and short-term partial feeding of, specific plant foods high in the antioxidant glutathione will impact total glutathione status, gamma-glutamyltransferase (GGT) activity, glucose control or insulin sensitivity in people with type 2 diabetes. Dietary education will include information on plant sources of glutathione, as well as, cooking methods to reduce glycation and lipid peroxidation during cooking, which may indirectly alter glutathione status by reduce demand for elimination of these compounds. Participants will be randomized to one of two groups: the educational intervention plus partial feeding of two small meals per day vs. a wait list control group that will receive standard advice on nutrition for diabetes. After 12 weeks, the intervention group will no longer receive foods, but will be followed for 12 additional weeks to determine if lasting effects are achieved. After 12 weeks, the control group will receive access to the educational materials, but will not receive study foods, to see if the educational intervention alone impacts food/nutrition choices. Both groups will have lab measures (as described above) again after this additional 12 weeks, for a total duration of 24 weeks in the trial.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1: Experimental Feeding

Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks.

Group Type: EXPERIMENTAL

GSH Foods

Intervention Type: OTHER

The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).

Nutrition education about glutathione sources in the diet

Intervention Type: OTHER

Four videos will outline food sources of glutathione, cooking methods to reduce systemic requirements for glutathione, food sources of nutrient cofactors for glutathione production and other related content.

Arm 2: Education Control

Standard of care medical nutrition education for type 2 diabetes will be provided in the form of electronic handouts and web-based resources.

Group Type: ACTIVE_COMPARATOR

Standard of care nutrition education for type 2 diabetes

Intervention Type: OTHER

The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.

Interventions

GSH Foods

The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).

Intervention Type: OTHER

Nutrition education about glutathione sources in the diet

Four videos will outline food sources of glutathione, cooking methods to reduce systemic requirements for glutathione, food sources of nutrient cofactors for glutathione production and other related content.

Intervention Type: OTHER

Standard of care nutrition education for type 2 diabetes

The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women
• Ages 18 to 65
• Type 2 diabetes
• Free of self-reported acute and confounding chronic diseases (e.g., heart failure, kidney disease, liver disease, gastrointestinal disorder) based on a standardized medical history questionnaire
• Free of alcoholism, smoking and major cardiovascular event with the past 6 months
• Not on insulin to help manage diabetes
• Planning on staying in the San Diego area for the next 6 months
• Willing to select plant-based foods from a "menu" and eat the selected foods provided by the study team
• Have access to the internet and a computer
• Willing to view 4 weekly educational classes online, followed by periodic telephone and email contacts
• Agree to schedule and complete periodic questionnaires and measurements during up to four total online appointments

Exclusion Criteria

• Alcoholism, smoking and recent cardiovascular events
• Individuals will be excluded if they report any dietary restrictions, allergies or preferences
• Unsuitability based on screening visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Ryan Bradley

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Bradley, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

180215

Identifier Type: -

Identifier Source: org_study_id