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

NCT07609992 | Completed

• 1 other identifier: v.1.0(29.05.2023)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus.
2. 2.To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus.
3. 3.To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus.
4. 4.To study the effect of Optifiber HCTK on weight loss and waist circumference reduction in patients with type 2 diabetes mellitus.

Conditions

Type 2 Diabetes (T2DM)

Keywords

type 2 diabetes mellitus; dietary fiber; partially hydrolized guar gum; dietary intervention; personalized approach

Outcome Measures

Primary Outcomes (1)

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

  84 days

Study Arms (2)

OptiFibre

EXPERIMENTAL

Dietary Supplement: Nestle Optifibre

Control

NO INTERVENTION

Interventions

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))

OptiFibre

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

State clinical hospital named after V.P. Demikhov

Moscow, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Professor. Head of the department of endocrinology, Institute of clinical medicine

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)