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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
90
200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
200 g/day of unsweetened yogurt
Center of Food and Fermentation Technologies
Tallinn, Harju, Estonia
Evaluation of the intestinal microbiota
Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.
Time frame: 14 days
Evaluation of blood lipid profile
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
Time frame: 14 days
Evaluation of blood glucose levels
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
Time frame: 14 days
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.
Time frame: 14 days
Evaluation of the defecation frequency
1. Evacuation frequency during 3 days pre- and post-dietary intervention. 2. Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention.
Time frame: 14 days
Evaluation of the defecation timing
Evacuation timing 3 days before sampling pre- and post-dietary intervention.
Time frame: 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).
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Time frame: 14 days
Evaluation of the blood vitamin D status
25-OH vitamin D pre- and post-dietary intervention in plasma.
Time frame: 14 days