Applications of a Functional Dairy Product in Diet Therapy

NCT07793487 | Enrolling By Invitation DMC

• 2 other identifiers: 33/RKE/2025UMEiN/2023/DPI/2866
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study will be to evaluate the effectiveness of dietary therapy using a functional dairy product, using fermented milk with selected probiotic cultures, in individuals with irritable bowel syndrome and metabolic syndrome. The technology for preparing fermented milk from probiotic bacteria and assessing its physicochemical and sensory characteristics was developed and conducted as part of the SUPRIM research project at the Department of Gastronomic Technology and Food Hygiene, Institute of Human Nutrition, Warsaw University of Life Sciences (SGGW). Compliance with dietary recommendations will be monitored by qualified dietitians, and will be monitored by a physician. Nutritional status, selected metabolic parameters, quality of life, and the occurrence of gastrointestinal symptoms will be assessed before and after the program. Patients' dietary habits will be monitored throughout the study.

Conditions

Metabolic Syndrome; IBS - Irritable Bowel Syndrome

Keywords

fermented milk; probiotic; metabolic syndrom; irritable bowel syndrom

Outcome Measures

Primary Outcomes (6)

• Quality of life and gastrointestinal symptoms,

  * Quality of life (SFHS SP-36 - 36-item survey, the results are converted to a scale of 0 to 100, where a higher score indicates better health) * Quality of Life Questionnaire with IBS (34 questions with answers are marked on a 5-point Likert scale (from not at all to very/extremely), the final result is converted into a scale from 0 to 100, where 100 means the highest quality of life, lower scores indicating more disability) * Severity of gastrointestinal symptoms and self-assessment of stool quality (The Bristol Stool Chart classifies stool poop into seven types based on its form - types 3 and 4 are considered normal, types 1 and 2 indicate hard, lumpy stools, and 6 and 7 indicate watery stools indicating diarrhea)

  From enrollment to the end of treatment at 8 weeks

• Indicators of carbohydrate, lipid metabolism & inflamtion, liver, pancreas function.

  * Indicators of carbohydrate and lipid metabolism: concentration of blood glucose, insulin, total, LDL, HDL cholesterol, triglycerides (mmol/l), glycated hemoglobin (% hemoglobin) * Indicators of inflammation severity: blood concentrations of C-reactive protein (mg/l), cytokine panel (using the Bio-Plex 200 system for immunofluorescence assays mikrog/l) * Indicators of liver and pancreas function: blood concentrations of enzymes liver function, gamma-glutamyltranspeptidase activity, and amylase and lipase activity (UI/l)

  From enrollment to the end of treatment at 8 weeks

• Body mass index

  \- body weight (kg) and height (m) will be used to calculate BMI (kg/m\^2)

  From enrollment to the end of treatment at 8 weeks

• Dietary habits

  Frequency of consumption of selected product groups (more than once a day, once a day, several times a week, once a week, several times a month, once a month less than once a week, never)

  tests will be performed before the start of the study and after 8 weeks of intervention and its completion

• Body composition

  Body composition using bioimpedance, Accuniq BC-750 device (% FM, % abdominal fat, %TBW, % MM),

  From enrollment to the end of treatment at 8 weeks

• Abdominal obesity

  \- waist circumference (cm): (\>80 cm for women and \>94 cm for men)

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

MS and IBS receiving new functional milk drink

EXPERIMENTAL

MS and IBS group receiving new functional, probiotic milk drink for 8 weeks (200 ml/d) (n=40)

Other: new functional milk drink

people with MS and IBS receiving conventional, acidified milk drink

ACTIVE COMPARATOR

people with MS and IBS receiving conventional, acidified milk drink (200 ml/d) for 8 weeks (n=40)

Other: conventional, acidified milk drink

Interventions

new functional milk drink OTHER

The study will use a fermented milk drink with the characteristics of sour milk, with the addition of a selected strain of lactic acid bacteria, with potential properties influencing not only peristalsis but also the metabolism of people with abdominal obesity. The milk drinks will be prepared based on technology developed as part of the SupRim project by the teams of Institute of Food and Nutrition, SGGW. Milk will then be inoculated with Levilactobacillus brevis B1 bacteria (2.5g of freeze-dried bacteria with a count of 1010 CFU/g per 100 liters of milk). The Levilactobacillus brevis B1 strain comes from the collection of the Department of Gastronomic Technology and Food Hygiene at the Institute of Food and Agriculture, SGGW. This strain inhibits the growth of pathogenic bacteria of the species Listeria monocytogenes, Bacillus subtilis, E. coli, Enterococcus feacium and Salmonella enteritidis (Patent No.: P.426002/UP RP: Zielińska et all, 2020).

MS and IBS receiving new functional milk drink

conventional, acidified milk drink OTHER

The study will use a conventional milk drink with the characteristics of sour milk, with the addition of a selected strain of commercially available lactic acid bacteria, produced as sour milk by Dorota Wesołek: Wesoła Zagroda.

people with MS and IBS receiving conventional, acidified milk drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 18.5 and \< 25 kg/m²
• adults \> 18 years of age,
• diagnosed with irritable bowel syndrome or at least one criterion of metabolic syndrome, in addition to abdominal obesity (hypertension and/or hyperlipidemia and/or glucose intolerance),
• not taking pro- and/or prebiotic supplements

You may not qualify if:

• Presence of chronic diseases such as cancer, kidney, liver, and thyroid disease, autoimmune diseases, and food allergies requiring the complete elimination of dairy products,
• Type 1 and type 2 diabetes treated with insulin
• Antibiotic therapy
• Consumption of a vegetarian diet or a low-energy diet (pharmacological treatment of obesity) and/or diets, e.g., high-fat, high-protein diets
• possession of electrostimulation and/or measurement devices that prevent measurement
• lack of informed consent to participate in the study

Sponsors & Collaborators

• Warsaw University of Life Sciences: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (SGGW)

Warsaw, 02-776, Poland

Location

MeSH Terms

Conditions

Metabolic Syndrome; Irritable Bowel Syndrome

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Ewa Lange

  Department of Dietetics, Warsaw University of Life Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university professor

Model Details: The study design is based on the assessment of dietary support for metabolic syndrome and irritable bowel syndrome by incorporating a functional milk drink (200ml/day) into the diet and comparing its impact with a control milk drink (200ml/day) (study group: 40 people, control group: 40 people). The planned dietary support period is 8 weeks, and the assessment of effectiveness will include a comparison of the effectiveness of incorporating milk drinks in the study and control groups, as well as a comparison of baseline and post-study results for individuals in each group.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will be available from december 2027 to december 2029.
• Access Criteria: Access to the IPD and supporting information (study protocol, reasons for not completing the intervention) will be provided to journals to which manuscripts describing the study results will be submitted.

Locations

PL (1)