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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Complete pre-study questionnaire Complete orientation to the study and provide voluntary consent to join the study 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 Record food intake and gastrointestinal symptoms for 3 days Collect health data and provide a 3-day food frequency questionnaire 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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Test product
* Dietary Supplement: Control product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Healthy adults consuming test product | Dietary Supplement: Test product<br>* 200 g/day of unsweetened yogurt supplemented with a dietary fiber blend<br>|
| Placebo Comparator: Control group<br>Healthy adults consuming control product | Dietary Supplement: Control product<br>* 200 g/day of unsweetened yogurt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the intestinal microbiota | Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention. | 14 days | 
| Evaluation of blood lipid profile | Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L). | 14 days | 
| Evaluation of blood glucose levels | Fasting glucose pre- and post-dietary intervention in plasma (mmol/L). | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the stool form | Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention. | 14 days | 
| Evaluation of the defecation frequency | Evacuation frequency during 3 days pre- and post-dietary intervention. Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention. | 14 days | 
| Evaluation of the defecation timing | Evacuation timing 3 days before sampling pre- and post-dietary intervention. | 14 days | 
| Evaluation of the gastrointestinal symptoms | Frequency and severity of the gastrointestinal symptoms (Constipation, Diarrhea, Bloating, Flatulence, Cramps, Stomach pain). Scale of frequency: Never, Less than 10 times a year, Once a month, Once a week, Every day. Scale of severity: I do not have any gastrointestinal symptoms, Mild (does not disturb), Moderate, Strong (disturbs considerably). | 14 days | 
| Evaluation of the blood vitamin D status | 25-OH vitamin D pre- and post-dietary intervention in plasma. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, bifidobacteria, fermented dairy product