Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Total glutathione
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1: Experimental Feeding
Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks.
Intervention: GSH Foods (Other)
Arm 1: Experimental Feeding
Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks.
Intervention: Nutrition education about glutathione sources in the diet (Other)
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.
Intervention: Standard of care nutrition education for type 2 diabetes (Other)
Outcomes
Primary Outcomes
Total glutathione
Time Frame: 12 weeks
Total glutathione concentration in the blood
gamma-glutamyltransferase (GGT)
Time Frame: 12 weeks
Measure of glutathione demand in the blood
Secondary Outcomes
- Fasting glucose(12 weeks)
- Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)(12 weeks)
- High density lipoprotein concentration (HDL)(12 weeks)
- Fasting insulin(12 weeks)
- Hemoglobin A1c(12 weeks)
- Triglycerides(12 weeks)
- Low density lipoprotein concentration (LDL-c)(12 weeks)
Investigators
Ryan Bradley
Assistant Professor
University of California, San Diego