Glutathione-rich Foods for Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): GSH Foods; Nutrition education about glutathione sources in the diet; Standard of care nutrition education for type 2 diabetes
Intervention type(s): Other; Other; Other
Intervention description(s): The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).; 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.; The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a partial controlled-feeding trial in which participants will be initially randomized to a "food intervention" or "education control" and then will be crossed-over after 12 weeks.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Glutathione; Nutrition