Glutathione-rich Foods for Type 2 Diabetes

NCT04386187 | Completed

• 1 other identifier: 180215
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Glutathione; Nutrition

Outcome Measures

Primary Outcomes (2)

• Total glutathione

  Total glutathione concentration in the blood

  12 weeks

• gamma-glutamyltransferase (GGT)

  Measure of glutathione demand in the blood

  12 weeks

Secondary Outcomes (7)

• Fasting glucose

  12 weeks

• Fasting insulin

  12 weeks

• Hemoglobin A1c

  12 weeks

• Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)

  12 weeks

• Low density lipoprotein concentration (LDL-c)

  12 weeks

Other Outcomes (9)

• Total glutathione

  24 weeks

• gamma-glutamyltransferase (GGT)

  24 weeks

• Fasting insulin

  24 weeks

Study Arms (2)

Arm 1: Experimental Feeding

EXPERIMENTAL

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

Other: GSH Foods; Other: Nutrition education about glutathione sources in the diet

Arm 2: Education Control

ACTIVE COMPARATOR

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

Other: Standard of care nutrition education for type 2 diabetes

Interventions

GSH Foods OTHER

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

Arm 1: Experimental Feeding

Nutrition education about glutathione sources in the diet OTHER

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.

Arm 1: Experimental Feeding

Standard of care nutrition education for type 2 diabetes OTHER

The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.

Arm 2: Education Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Alcoholism, smoking and recent cardiovascular events
• Individuals will be excluded if they report any dietary restrictions, allergies or preferences
• Unsuitability based on screening visit

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ryan Bradley, ND, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: May 13, 2020
• Study Start: July 28, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)