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Completed

NCT Number: NCT04386187

Glutathione-rich Foods for Type 2 Diabetes

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. Total glutathione

    Time frame: 12 weeks

    Total glutathione concentration in the blood

  2. gamma-glutamyltransferase (GGT)

    Time frame: 12 weeks

    Measure of glutathione demand in the blood

Secondary outcomes

  1. Fasting glucose

    Time frame: 12 weeks

    Serum glucose concentration while fasting

  2. Fasting insulin

    Time frame: 12 weeks

    Plasma insulin concentration while fasting

  3. Hemoglobin A1c

    Time frame: 12 weeks

    Measure of glycemic control

  4. Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)

    Time frame: 12 weeks

    Estimate of insulin resistance

  5. Low density lipoprotein concentration (LDL-c)

    Time frame: 12 weeks

    concentration of LDL lipoproteins in serum

  6. High density lipoprotein concentration (HDL)

    Time frame: 12 weeks

    concentration of HDL lipoproteins in serum

  7. Triglycerides

    Time frame: 12 weeks

    concentration of triglycerides in serum

Other outcomes

  1. Total glutathione

    Time frame: 24 weeks

    Total glutathione concentration in the blood

  2. gamma-glutamyltransferase (GGT)

    Time frame: 24 weeks

    Measure of glutathione demand in the blood

  3. Fasting insulin

    Time frame: 24 weeks

    Plasma insulin concentration while fasting

  4. Fasting glucose

    Time frame: 24 weeks

    Serum glucose concentration while fasting

  5. Hemoglobin A1c

    Time frame: 24 weeks

    Measure of glycemic control

  6. Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)

    Time frame: 24 weeks

    Estimate of insulin resistance

  7. Low density lipoprotein concentration (LDL-c)

    Time frame: 24 weeks

    concentration of LDL lipoproteins in serum

  8. High density lipoprotein concentration (HDL)

    Time frame: 24 weeks

    concentration of HDL lipoproteins in serum

  9. Triglycerides

    Time frame: 24 weeks

    concentration of triglycerides in serum

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: GSH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 13, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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