The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.

Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.

Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dietary Fiber and Gut Microbiome Study

NCT05424640

Healthy

COMPLETED NA

Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols

NCT01521156

Mild Hypercholesterolemic Subjects

COMPLETED NA

Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

NCT01571869

Mildly Hypercholesterolemic Subjects

COMPLETED NA

Gut Health Response to Dietary Fiber

NCT01321736

Dietary Fiber

COMPLETED NA

Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)

NCT01574469

Mildly Hypercholesterolemic Subjects

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.

PRE-STUDY EVALUATION AND TESTING

1. Complete pre-study questionnaire
2. Complete orientation to the study and provide voluntary consent to join the study
3. Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1\. Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1. Record food intake and gastrointestinal symptoms for 3 days
2. Collect health data and provide a 3-day food frequency questionnaire
3. Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES

1\. Provide the blood sample at the laboratory in the morning in an overnight fasted state.

DIETARY INTERVENTION

1\. Daily intake of a test or control product for two weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test group

Healthy adults consuming test product

Group Type EXPERIMENTAL

Test product

Intervention Type DIETARY_SUPPLEMENT

200 g/day of unsweetened yogurt supplemented with a dietary fiber blend

Control group

Healthy adults consuming control product

Group Type PLACEBO_COMPARATOR

Control product

Intervention Type DIETARY_SUPPLEMENT

200 g/day of unsweetened yogurt

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test product

200 g/day of unsweetened yogurt supplemented with a dietary fiber blend

Intervention Type DIETARY_SUPPLEMENT

Control product

200 g/day of unsweetened yogurt

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 25-55
* Normal bowel function
* Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
* Ability to provide a signed written informed consent
* Willing to provide stool and blood specimens 2 times over the 2-week study period

Exclusion Criteria

* Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
* Medication: statins, blood pressure medications, antidepressants, other prescription medications
* History of bariatric operation, removal of the gallbladder.
* Food allergies, lactose intolerance
* Recent (previous 3 months) use of antibiotics
* Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
* Current pregnancy or breastfeeding
* Volunteers showing previously unrecognized illness will also be excluded
* Individual unable to give informed consent

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes