The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Harjumaa
-
Tallinn, Harjumaa, Estland, 12618
- Center of Food and Fermentation Technologies
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Test group
Healthy adults consuming test product
|
200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
|
|
Placebo komparator: Control group
Healthy adults consuming control product
|
200 g/day of unsweetened yogurt
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of the intestinal microbiota
Tidsramme: 14 days
|
Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.
|
14 days
|
|
Evaluation of blood lipid profile
Tidsramme: 14 days
|
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
|
14 days
|
|
Evaluation of blood glucose levels
Tidsramme: 14 days
|
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
|
14 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of the stool form
Tidsramme: 14 days
|
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
Tidsramme: 14 days
|
|
14 days
|
|
Evaluation of the defecation timing
Tidsramme: 14 days
|
Evacuation timing 3 days before sampling pre- and post-dietary intervention.
|
14 days
|
|
Evaluation of the gastrointestinal symptoms
Tidsramme: 14 days
|
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
Tidsramme: 14 days
|
25-OH vitamin D pre- and post-dietary intervention in plasma.
|
14 days
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Madis Jaagura, MSc, TFTAK
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2014-2020.4.02.19-0198
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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