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:

1. To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus. 2. To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus. 3. To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus. 4. 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.

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Key information

Conditions

Type 2 Diabetes (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State clinical hospital named after V.P. Demikhov

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Nestle Optifibre

Dietary 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))

Primary outcomes

Change from baseline in HbA1c in OptiFibre group in comparison to HbA1c control group in 3 months

Time frame: 84 days

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study 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"

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 27, 2026
Registry last updated: May 27, 2026

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.

Published trials that share one or more normalized conditions with this study.

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