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Glutathione-rich Foods for Type 2 Diabetes (GSH)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GSH Foods
Nutrition education about glutathione sources in the diet
Standard of care nutrition education for type 2 diabetes
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Glutathione, Nutrition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Experimental Feeding

Arm 2: Education Control

Arm Description

Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks.

Standard of care medical nutrition education for type 2 diabetes will be provided in the form of electronic handouts and web-based resources.

Outcomes

Primary Outcome Measures

Total glutathione
Total glutathione concentration in the blood
gamma-glutamyltransferase (GGT)
Measure of glutathione demand in the blood

Secondary Outcome Measures

Fasting glucose
Serum glucose concentration while fasting
Fasting insulin
Plasma insulin concentration while fasting
Hemoglobin A1c
Measure of glycemic control
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Estimate of insulin resistance
Low density lipoprotein concentration (LDL-c)
concentration of LDL lipoproteins in serum
High density lipoprotein concentration (HDL)
concentration of HDL lipoproteins in serum
Triglycerides
concentration of triglycerides in serum

Full Information

First Posted
February 27, 2020
Last Updated
January 20, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04386187
Brief Title
Glutathione-rich Foods for Type 2 Diabetes
Acronym
GSH
Official Title
Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
April 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Glutathione, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Experimental Feeding
Arm Type
Experimental
Arm Description
Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks.
Arm Title
Arm 2: Education Control
Arm Type
Active Comparator
Arm Description
Standard of care medical nutrition education for type 2 diabetes will be provided in the form of electronic handouts and web-based resources.
Intervention Type
Other
Intervention Name(s)
GSH Foods
Intervention Description
The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).
Intervention Type
Other
Intervention Name(s)
Nutrition education about glutathione sources in the diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care nutrition education for type 2 diabetes
Intervention Description
The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.
Primary Outcome Measure Information:
Title
Total glutathione
Description
Total glutathione concentration in the blood
Time Frame
12 weeks
Title
gamma-glutamyltransferase (GGT)
Description
Measure of glutathione demand in the blood
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting glucose
Description
Serum glucose concentration while fasting
Time Frame
12 weeks
Title
Fasting insulin
Description
Plasma insulin concentration while fasting
Time Frame
12 weeks
Title
Hemoglobin A1c
Description
Measure of glycemic control
Time Frame
12 weeks
Title
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Description
Estimate of insulin resistance
Time Frame
12 weeks
Title
Low density lipoprotein concentration (LDL-c)
Description
concentration of LDL lipoproteins in serum
Time Frame
12 weeks
Title
High density lipoprotein concentration (HDL)
Description
concentration of HDL lipoproteins in serum
Time Frame
12 weeks
Title
Triglycerides
Description
concentration of triglycerides in serum
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Total glutathione
Description
Total glutathione concentration in the blood
Time Frame
24 weeks
Title
gamma-glutamyltransferase (GGT)
Description
Measure of glutathione demand in the blood
Time Frame
24 weeks
Title
Fasting insulin
Description
Plasma insulin concentration while fasting
Time Frame
24 weeks
Title
Fasting glucose
Description
Serum glucose concentration while fasting
Time Frame
24 weeks
Title
Hemoglobin A1c
Description
Measure of glycemic control
Time Frame
24 weeks
Title
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Description
Estimate of insulin resistance
Time Frame
24 weeks
Title
Low density lipoprotein concentration (LDL-c)
Description
concentration of LDL lipoproteins in serum
Time Frame
24 weeks
Title
High density lipoprotein concentration (HDL)
Description
concentration of HDL lipoproteins in serum
Time Frame
24 weeks
Title
Triglycerides
Description
concentration of triglycerides in serum
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Bradley, ND, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Glutathione-rich Foods for Type 2 Diabetes

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