Type 2 Diabetes (T2DM)NCT07609992

The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus

A study testing Nestle Optifibre in people with Type 2 Diabetes (T2DM), run by Pirogov Russian National Research Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are: 1. To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus. 2. Read more about this study

Who is it for?: Ages 45 to 60 years
Conditions the study is for: Type 2 Diabetes (T2DM)
What is being tested?: Nestle Optifibre
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteRussia
Study dates: 1 Jun 2023to 30 Sep 2024
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 45 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Type 2 diabetes mellitus;
The duration of the disease is less than 5 years;
Age from 45 to 60 years;
HbA1c up to 7.5%;
Body mass index from 27 to 35 kg/m2;
Patients who were assigned flash monitoring to control carbohydrate metabolism and complex therapy as part of routine clinical practice;
Voluntary informed consent to participate in the study.

Who cannot join

Use of antidiabetic drugs other than metformin, DPP-4 inhibitors or SGLT2 inhibitors
Intestinal diseases (ulcerative colitis, Crohn's disease, etc.)
Pregnancy
AIDS/HIV
The use of other dietary fibers.
Participation in another clinical trial within the last 30 days or simultaneous participation in another clinical trial.

Trial locations and contacts

1 site in 1 country.

Russia1 site

State clinical hospital named after V.P. Demikhov
Moscow

Other trials in Russia

About this study

Official title: Prospective-retrospective Observational Minimal Intervention Study "The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus"

The goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are:

To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on weight loss and waist circumference reduction in patients with type 2 diabetes mellitus.

The observational study is planned to include approximately 80 patients diagnosed with type 2 diabetes mellitus, with 40 patients divided into the main and control groups. In the control group, the necessary information will be collected retrospectively using archived patient data. In the main (study) group, data will be collected prospectively.

Conditions: Type 2 Diabetes (T2DM)
Being tested: Nestle Optifibre
Keywords: type 2 diabetes mellitus, dietary fiber, partially hydrolized guar gum, dietary intervention, personalized approach
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.

Nestle OptifibreDietary supplement
The main (study) group will include patients who are additionally prescribed dietary fiber supplements Optifiber (regimen of use from 1 to 3 days - 1 sachet per day (5 g) - lunch, from 4 to 6 days - 2 sachets per day (10 g) - lunch + dinner, from 7 to 90 ± 2 days - 3 sachets per day (15 g))

Study groups in NCT07609992
Study group	Role	What they receive
OptiFibre	Experimental	Not described Receives: Dietary Supplement: Nestle Optifibre
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in HbA1c in OptiFibre group in comparison to HbA1c control group in 3 months
Measured: 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202330 Sep 2024

First posted27 May 2026
Study start1 Jun 2023
Primary completion30 Mar 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07609992
Sponsor's protocol ID: v.1.0(29.05.2023)
Status last verified: May 2026
First submitted: 15 May 2026
Last updated: 27 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus

All Type 2 Diabetes (T2DM) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective-retrospective Observational Minimal Intervention Study "The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus"
ClinicalTrials.gov ID: NCT07609992
Acronym / sponsor ID: v.1.0(29.05.2023)
Conditions: Type 2 Diabetes (T2DM)
Keywords: type 2 diabetes mellitus, dietary fiber, partially hydrolized guar gum, dietary intervention, personalized approach
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Pirogov Russian National Research Medical UniversityUniversity, hospital or other
Study start: 1 Jun 2023 (actual)
Primary completion: 30 Mar 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 27 May 2026 (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 goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are:

To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on weight loss and waist circumference reduction in patients with type 2 diabetes mellitus.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
OptiFibre	Experimental	Dietary Supplement: Nestle Optifibre
Control	No intervention	–

Who may qualify

Ages: 45 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Type 2 diabetes mellitus;
The duration of the disease is less than 5 years;
Age from 45 to 60 years;
HbA1c up to 7.5%;
Body mass index from 27 to 35 kg/m2;

Key exclusion criteria (6 listed)

Use of antidiabetic drugs other than metformin, DPP-4 inhibitors or SGLT2 inhibitors
Intestinal diseases (ulcerative colitis, Crohn's disease, etc.)
Pregnancy
AIDS/HIV
The use of other dietary fibers.

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
Nestle OptifibreThe main (study) group will include patients who are additionally prescribed dietary fiber supplements Optifiber (regimen of use from 1 to 3 days - 1 sachet per day (5 g) - lunch, from 4 to 6 days - 2 sachets per day (10 g) - lunch + dinner, from 7 to 90 ± 2 days - 3 sachets per day (15 g))	Dietary supplement	OptiFibre

Primary outcome

Change from baseline in HbA1c in OptiFibre group in comparison to HbA1c control group in 3 months
Time frame: 84 days

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 27 May 2026.
Individual participant dataSharing planned: Yes

Related trials for Type 2 Diabetes (T2DM)

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nestle Optifibre in people with Type 2 Diabetes (T2DM), run by Pirogov Russian National Research Medical University at 1 site in Russia.

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 7 inclusion and 6 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 27 May 2026. 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 Russia. 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?

Change from baseline in HbA1c in OptiFibre group in comparison to HbA1c control group in 3 months (time frame: 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07609992.

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 27 May 2026.