NCT04386187

Glutathione-rich Foods for Type 2 Diabetes

Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-07-28
• Primary completion: 2021-04-02
• Completion: 2021-04-02
• First posted: 2020-05-13
• Last updated: 2022-01-21

Locations

1 site across 1 country: United States