The Effect of Functional Dairy Products Enriched With Die... | NCT04811157

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

NCT04811157

Sponsor

Center of Food and Fermentation Technologies

Status

Completed

Last Update Posted

Mar 23, 2021Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Test product
Control product

Countries

Estonia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Mar 18, 2021

First Submission Date that Met QC Criteria

Mar 19, 2021

First Posted Date

Mar 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2021

Last Update Posted Date

Mar 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Madis Jaagura, Project Manager, Center of Food and Fermentation TechnologiesPrincipal Investigator

Lead Sponsor

Center of Food and Fermentation TechnologiesOTHER

Collaborators

Name	Class
SYNLAB Eesti OÜ, Tallinn, Estonia	UNKNOWN
AS FARMI Piimatööstus, Jõhvi, Estonia	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	Healthy adults consuming test product	Dietary Supplement: Test product
Control group	Placebo Comparator	Healthy adults consuming control product	Dietary Supplement: Control product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test product	Dietary Supplement	200 g/day of unsweetened yogurt supplemented with a dietary fiber blend	Test group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Madis Jaagura, MSc	TFTAK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Food and Fermentation Technologies		Tallinn	Harju	12618	Estonia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Anonymized participant data could be made available for subsequent analysis in the mentioned institution (TFTAK).

Data made public will include only aggregates or summaries of the collected data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Mar 11, 2020	Mar 18, 2021	ICF_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided