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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811157
• Other study ID #: 2014-2020.4.02.19-0198
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2021
• Source: Center of Food and Fermentation Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Test product
200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
• Control product
200 g/day of unsweetened yogurt

Locations

Country	Name	City	State
Estonia	Center of Food and Fermentation Technologies	Tallinn	Harjumaa

Sponsors (3)

Lead Sponsor	Collaborator
Center of Food and Fermentation Technologies	AS FARMI Piimatööstus, Jõhvi, Estonia, SYNLAB Eesti OÜ, Tallinn, Estonia

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the intestinal microbiota	Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.	14 days
Primary	Evaluation of blood lipid profile	Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).	14 days
Primary	Evaluation of blood glucose levels	Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).	14 days
Secondary	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
Secondary	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
Secondary	Evaluation of the defecation timing	Evacuation timing 3 days before sampling pre- and post-dietary intervention.	14 days
Secondary	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
Secondary	Evaluation of the blood vitamin D status	25-OH vitamin D pre- and post-dietary intervention in plasma.	14 days