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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Experimental Feeding | Experimental | Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks. |
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| Arm 2: Education Control | Active Comparator | Standard of care medical nutrition education for type 2 diabetes will be provided in the form of electronic handouts and web-based resources. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSH Foods | Other | The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH). |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Serum glucose concentration while fasting | 12 weeks |
| Fasting insulin | Plasma insulin concentration while fasting | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total glutathione | Total glutathione concentration in the blood | 24 weeks |
| gamma-glutamyltransferase (GGT) | Measure of glutathione demand in the blood |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Bradley, ND, MPH | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| Nutrition education about glutathione sources in the diet | 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. |
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| Standard of care nutrition education for type 2 diabetes | Other | The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links. |
|
| 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 |
| 24 weeks |
| Fasting insulin | Plasma insulin concentration while fasting | 24 weeks |
| Fasting glucose | Serum glucose concentration while fasting | 24 weeks |
| Hemoglobin A1c | Measure of glycemic control | 24 weeks |
| Homeostasis Assessment Index of Insulin Resistance (HOMA-IR) | Estimate of insulin resistance | 24 weeks |
| Low density lipoprotein concentration (LDL-c) | concentration of LDL lipoproteins in serum | 24 weeks |
| High density lipoprotein concentration (HDL) | concentration of HDL lipoproteins in serum | 24 weeks |
| Triglycerides | concentration of triglycerides in serum | 24 weeks |
| D004700 | Endocrine System Diseases |