Glutathione-rich Foods for Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— GSH  

Official title:

Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386187
• Other study ID #: 180215
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: April 2, 2021

Study information

• Verified date: January 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• GSH Foods
The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).
• Nutrition 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.
• Standard 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total glutathione	Total glutathione concentration in the blood	24 weeks
Other	gamma-glutamyltransferase (GGT)	Measure of glutathione demand in the blood	24 weeks
Other	Fasting insulin	Plasma insulin concentration while fasting	24 weeks
Other	Fasting glucose	Serum glucose concentration while fasting	24 weeks
Other	Hemoglobin A1c	Measure of glycemic control	24 weeks
Other	Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)	Estimate of insulin resistance	24 weeks
Other	Low density lipoprotein concentration (LDL-c)	concentration of LDL lipoproteins in serum	24 weeks
Other	High density lipoprotein concentration (HDL)	concentration of HDL lipoproteins in serum	24 weeks
Other	Triglycerides	concentration of triglycerides in serum	24 weeks
Primary	Total glutathione	Total glutathione concentration in the blood	12 weeks
Primary	gamma-glutamyltransferase (GGT)	Measure of glutathione demand in the blood	12 weeks
Secondary	Fasting glucose	Serum glucose concentration while fasting	12 weeks
Secondary	Fasting insulin	Plasma insulin concentration while fasting	12 weeks
Secondary	Hemoglobin A1c	Measure of glycemic control	12 weeks
Secondary	Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)	Estimate of insulin resistance	12 weeks
Secondary	Low density lipoprotein concentration (LDL-c)	concentration of LDL lipoproteins in serum	12 weeks
Secondary	High density lipoprotein concentration (HDL)	concentration of HDL lipoproteins in serum	12 weeks
Secondary	Triglycerides	concentration of triglycerides in serum	12 weeks