University of California, San Diego
San Diego, California, 92093, United States
NCT Number: NCT04386187
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
San Diego, California, 92093, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks
Total glutathione concentration in the blood
Time frame: 12 weeks
Measure of glutathione demand in the blood
Time frame: 12 weeks
Serum glucose concentration while fasting
Time frame: 12 weeks
Plasma insulin concentration while fasting
Time frame: 12 weeks
Measure of glycemic control
Time frame: 12 weeks
Estimate of insulin resistance
Time frame: 12 weeks
concentration of LDL lipoproteins in serum
Time frame: 12 weeks
concentration of HDL lipoproteins in serum
Time frame: 12 weeks
concentration of triglycerides in serum
Time frame: 24 weeks
Total glutathione concentration in the blood
Time frame: 24 weeks
Measure of glutathione demand in the blood
Time frame: 24 weeks
Plasma insulin concentration while fasting
Time frame: 24 weeks
Serum glucose concentration while fasting
Time frame: 24 weeks
Measure of glycemic control
Time frame: 24 weeks
Estimate of insulin resistance
Time frame: 24 weeks
concentration of LDL lipoproteins in serum
Time frame: 24 weeks
concentration of HDL lipoproteins in serum
Time frame: 24 weeks
concentration of triglycerides in serum
University of California, San Diego
Other
Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes
Acronym: GSH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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