Type 2 DiabetesGSHNCT04386187
Glutathione-rich Foods for Type 2 Diabetes
A study testing GSH Foods and Nutrition education about glutathione sources in the diet in people with Type 2 Diabetes, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GSH Foods and Nutrition education about glutathione sources in the diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- Not on insulin to help manage diabetes
Show all 11Show fewer
- 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
Who cannot join
- Alcoholism, smoking and recent cardiovascular events
- Individuals will be excluded if they report any dietary restrictions, allergies or preferences
- Unsuitability based on screening visit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Official title: Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- GSH Foods, Nutrition education about glutathione sources in the diet, Standard of care nutrition education for type 2 diabetes
- Keywords
- Type 2 diabetes, Glutathione, Nutrition
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSH FoodsOther
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 dietOther
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 diabetesOther
The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Experimental Feeding | Experimental | Small glutathione-rich meals will be prepared and delivered to participants for 12 weeks. Receives: 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. Receives: Other: Standard of care nutrition education for type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total glutathione
Total glutathione concentration in the blood
Measured: 12 weeks
gamma-glutamyltransferase (GGT)
Measure of glutathione demand in the blood
Measured: 12 weeks
Secondary outcomes (7)
Fasting glucose
Serum glucose concentration while fasting
Measured: 12 weeks
Fasting insulin
Plasma insulin concentration while fasting
Measured: 12 weeks
Hemoglobin A1c
Measure of glycemic control
Measured: 12 weeks
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Estimate of insulin resistance
Measured: 12 weeks
Low density lipoprotein concentration (LDL-c)
concentration of LDL lipoproteins in serum
Measured: 12 weeks
High density lipoprotein concentration (HDL)
concentration of HDL lipoproteins in serum
Measured: 12 weeks
Triglycerides
concentration of triglycerides in serum
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start28 Jul 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Bradley, University of California, San Diego
- Investigators
- Ryan Bradley, ND, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386187
- Sponsor's protocol ID
- 180215
- Acronym
- GSH
- Status last verified
- Jan 2022
- First submitted
- 27 Feb 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the "Glutathione Support for Health (GSH)" Plan on Glutathione Status in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04386187
- Acronym / sponsor ID
- GSH / 180215
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Glutathione, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Experimental Feeding | Experimental | Other: GSH Foods, Other: Nutrition education about glutathione sources in the dietSmall glutathione-rich meals will be prepared and delivered to participants for 12 weeks. |
| Arm 2: Education Control | Active comparator | Other: Standard of care nutrition education for type 2 diabetesStandard of care medical nutrition education for type 2 diabetes will be provided in the form of electronic handouts and web-based resources. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- Alcoholism, smoking and recent cardiovascular events
- Individuals will be excluded if they report any dietary restrictions, allergies or preferences
- Unsuitability based on screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSH FoodsThe intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH). | Other | Arm 1: Experimental Feeding |
| Nutrition education about glutathione sources in the dietFour 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. | Other | Arm 1: Experimental Feeding |
| Standard of care nutrition education for type 2 diabetesThe educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links. | Other | Arm 2: Education Control |
Primary outcome
Total glutathione
Time frame: 12 weeks
Total glutathione concentration in the blood
gamma-glutamyltransferase (GGT)
Time frame: 12 weeks
Measure of glutathione demand in the blood
7 secondary outcomes
Fasting glucose
Time frame: 12 weeks
Fasting insulin
Time frame: 12 weeks
Hemoglobin A1c
Time frame: 12 weeks
Homeostasis Assessment Index of Insulin Resistance (HOMA-IR)
Time frame: 12 weeks
Low density lipoprotein concentration (LDL-c)
Time frame: 12 weeks
High density lipoprotein concentration (HDL)
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Bradley, ND, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSH Foods and Nutrition education about glutathione sources in the diet in people with Type 2 Diabetes, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total glutathione (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.