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

NCT07609992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-27

No results posted yet for this study

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. 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.

Conditions

  • Type 2 Diabetes (T2DM)

Interventions

DIETARY_SUPPLEMENT

Nestle Optifibre

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))

Sponsors & Collaborators

  • Pirogov Russian National Research Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-03-30
Completion
2024-09-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609992 on ClinicalTrials.gov