Glutathione-rich Foods for Type 2 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Glutathione.

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.

It had two arms (groups): Arm 1: Experimental Feeding (experimental) and Arm 2: Education Control (active comparator).

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.

The registry classes the interventions as other.

More on the Plan

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 Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 11 inclusion and 3 exclusion criteria; among the exclusions: alcoholism, smoking and recent cardiovascular events; individuals will be excluded if they report any dietary restrictions, allergies or preferences; unsuitability based on screening visit.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Glutathione and the comparison in turn, acting as their own control.

In this single-blind Glutathione study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2020-07-28 with completion listed for 2021-04-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total glutathione (time frame: 12 weeks). gamma-glutamyltransferase (GGT) (time frame: 12 weeks).

It also tracked 7 secondary outcomes, for example Fasting glucose, Fasting insulin, Hemoglobin A1c, Homeostasis Assessment Index of Insulin Resistance (HOMA-IR), Low density lipoprotein concentration (LDL-c) and High density lipoprotein concentration (HDL).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.