Clinical trial NCT04386187: Glutathione-rich Foods for Type 2 Diabetes
Official title: Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Glutathione
Nutrition
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total glutathione
timeFrame: 12 weeks
measure: gamma-glutamyltransferase (GGT)
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
measure: Fasting insulin
timeFrame: 12 weeks
measure: Hemoglobin A1c
timeFrame: 12 weeks
measure: Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
timeFrame: 12 weeks
measure: Low density lipoprotein concentration (LDL-c)
timeFrame: 12 weeks
measure: High density lipoprotein concentration (HDL)
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
Other outcomes:
measure: Total glutathione
timeFrame: 24 weeks
measure: gamma-glutamyltransferase (GGT)
timeFrame: 24 weeks
measure: Fasting insulin
timeFrame: 24 weeks
measure: Fasting glucose
timeFrame: 24 weeks
measure: Hemoglobin A1c
timeFrame: 24 weeks
measure: Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
timeFrame: 24 weeks
measure: Low density lipoprotein concentration (LDL-c)
timeFrame: 24 weeks
measure: High density lipoprotein concentration (HDL)
timeFrame: 24 weeks
measure: Triglycerides
timeFrame: 24 weeks
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Ryan Bradley, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References: