Glutathione-rich Foods for Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: GSH Foods
* Other: Nutrition education about glutathione sources in the diet
* Other: Standard of care nutrition education for type 2 diabetes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Experimental Feeding<br>Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks. | Other: GSH Foods<br>* The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).<br>Other: Nutrition education about glutathione sources in the diet<br>* 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.<br>|
| Active Comparator: Arm 2: Education Control<br>Standard of care medical nutrition education for type 2 diabetes will be provided in the form of electronic handouts and web-based resources. | Other: Standard of care nutrition education for type 2 diabetes<br>* The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total glutathione | Total glutathione concentration in the blood | 12 weeks | 
| gamma-glutamyltransferase (GGT) | Measure of glutathione demand in the blood | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Serum glucose concentration while fasting | 12 weeks | 
| Fasting insulin | Plasma insulin concentration while fasting | 12 weeks | 
| Hemoglobin A1c | Measure of glycemic control | 12 weeks | 
| Homeostasis Assessment Index of Insulin Resistance (HOMA-IR) | Estimate of insulin resistance | 12 weeks | 
| Low density lipoprotein concentration (LDL-c) | concentration of LDL lipoproteins in serum | 12 weeks | 
| High density lipoprotein concentration (HDL) | concentration of HDL lipoproteins in serum | 12 weeks | 
| Triglycerides | concentration of triglycerides in serum | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Type 2 diabetes, Glutathione