An interventional study of GSH Foods and Nutrition education about glutathione sources in the diet in Type 2 Diabetes, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 12 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks.
Other: GSH Foods · Other: Nutrition education about glutathione sources in the diet
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
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.
Total glutathione
Total glutathione concentration in the blood
Time frame: 12 weeks
gamma-glutamyltransferase (GGT)
Measure of glutathione demand in the blood
Time frame: 12 weeks
Fasting glucose
Serum glucose concentration while fasting
Time frame: 12 weeks
Fasting insulin
Plasma insulin concentration while fasting
Time frame: 12 weeks
Hemoglobin A1c
Measure of glycemic control
Time frame: 12 weeks
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Estimate of insulin resistance
Time frame: 12 weeks
Low density lipoprotein concentration (LDL-c)
concentration of LDL lipoproteins in serum
Time frame: 12 weeks
High density lipoprotein concentration (HDL)
concentration of HDL lipoproteins in serum
Time frame: 12 weeks
Triglycerides
concentration of triglycerides in serum
Time frame: 12 weeks
Total glutathione
Total glutathione concentration in the blood
Time frame: 24 weeks
gamma-glutamyltransferase (GGT)
Measure of glutathione demand in the blood
Time frame: 24 weeks
Fasting insulin
Plasma insulin concentration while fasting
Time frame: 24 weeks
Fasting glucose
Serum glucose concentration while fasting
Time frame: 24 weeks
Hemoglobin A1c
Measure of glycemic control
Time frame: 24 weeks
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Estimate of insulin resistance
Time frame: 24 weeks
Low density lipoprotein concentration (LDL-c)
concentration of LDL lipoproteins in serum
Time frame: 24 weeks
High density lipoprotein concentration (HDL)
concentration of HDL lipoproteins in serum
Time frame: 24 weeks
Triglycerides
concentration of triglycerides in serum
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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