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Could a natural grain-bran supplement free type 2 diabetes patients from daily pills?

NCT ID NCT07768280

Disease control Sponsor: Jiangxi University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether adding Hebenrun, a functional food made from natural grain bran, to standard metformin treatment helps people with type 2 diabetes achieve better blood sugar control. About 110 adults with type 2 diabetes will be randomly assigned to take either metformin alone or metformin plus Hebenrun for 48 weeks. The main question is whether more people in the Hebenrun group can completely stop all diabetes medication while keeping their blood sugar in a healthy range.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hebenrun, a functional food made from natural grain bran, taken as a supplement alongside metformin
What this could lead to
If it works, this could point toward a way for some people with type 2 diabetes to manage their blood sugar without daily medication.
What could go wrong
This is a small, early-stage trial, and the supplement may not help everyone. Stopping diabetes drugs carries risks, and the results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Meets the Western medicine diagnostic criteria for type 2 diabetes (T2DM), referring to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition). If typical diabetes symptoms are present (such as polydipsia, polyuria, polyphagia, unexplained weight loss), meeting any one of the following can confirm the diagnosis: fasting blood glucose (FBG) ≥7.0 mmol/L; random blood glucose ≥11.1 mmol/L; oral glucose tolerance test (OGTT) 2-hour blood glucose ≥11.1 mmol/L; glycated hemoglobin (HbA1c) ≥6.5%. If typical diabetes symptoms are lacking, two of the above blood glucose indicators at the same time point or at two different time points (excluding random blood glucose) need to reach or exceed the diagnostic cut-off point to diagnose diabetes. 2. Age 18-65 years, glycated hemoglobin (HbA1c): 6.5%-8.5%. 3. Good patient compliance, cooperation with treatment and follow-up. 4. The research has been approved by the hospital ethics committee, and all patients voluntarily participate and sign informed consent. Exclusion Criteria: 1. Type 1 diabetes, gestational diabetes, and special types of diabetes. 2. History of acute diabetic complications (ketoacidosis, hyperosmolar coma, lactic acidosis). 3. Major organ diseases (severe heart, liver, kidney dysfunction), malignant tumors, or severe mental disorders. 4. Contraindications or allergy history to any component of Hebenrun. 5. Psychotropic drug dependence, accompanied by obvious anxiety or depression tendencies. 6. Women preparing for pregnancy, during pregnancy, and lactation. 7. Expected poor compliance or language communication dysfunction. 8. Already enrolled or about to enroll in other clinical studies. Withdrawal/Discontinuation Criteria: 1. Subjects actively request withdrawal. 2. Unable to contact during follow-up. 3. Adverse reactions or disease changes making it unsuitable to continue participation. 4. The researcher determines that continued participation is detrimental to the subject. 5. Unable to follow the prescribed treatment regimen or unable to persist with medication.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    Nanchang, Jiangxi, 330006, China

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