Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Glutathione, Nutrition
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.
Interventions
OTHERGSH Foods
The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).
OTHERNutrition education about glutathione sources in the diet
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.
OTHERStandard of care nutrition education for type 2 diabetes
The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total glutathione | 12 weeks | Total glutathione concentration in the blood |
| gamma-glutamyltransferase (GGT) | 12 weeks | Measure of glutathione demand in the blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | 12 weeks | Serum glucose concentration while fasting |
| Fasting insulin | 12 weeks | Plasma insulin concentration while fasting |
| Hemoglobin A1c | 12 weeks | Measure of glycemic control |
| Homeostasis Assessment Index of Insulin Resistance (HOMA-IR) | 12 weeks | Estimate of insulin resistance |
| Low density lipoprotein concentration (LDL-c) | 12 weeks | concentration of LDL lipoproteins in serum |
| High density lipoprotein concentration (HDL) | 12 weeks | concentration of HDL lipoproteins in serum |
| Triglycerides | 12 weeks | concentration of triglycerides in serum |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total glutathione | 24 weeks | Total glutathione concentration in the blood |
| Fasting insulin | 24 weeks | Plasma insulin concentration while fasting |
| gamma-glutamyltransferase (GGT) | 24 weeks | Measure of glutathione demand in the blood |
| Fasting glucose | 24 weeks | Serum glucose concentration while fasting |
| Hemoglobin A1c | 24 weeks | Measure of glycemic control |
| Homeostasis Assessment Index of Insulin Resistance (HOMA-IR) | 24 weeks | Estimate of insulin resistance |
| Low density lipoprotein concentration (LDL-c) | 24 weeks | concentration of LDL lipoproteins in serum |
| High density lipoprotein concentration (HDL) | 24 weeks | concentration of HDL lipoproteins in serum |
| Triglycerides | 24 weeks | concentration of triglycerides in serum |
Countries
United States
Outcome results
None listed