Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
27. april 2026 opdateret af: Universidade Nova de Lisboa
The proposed study aims to evaluate the impact on intestinal and oral microbiota composition and the metabolic effects of the daily consumption of a wheat-based fermented beverage, developed under the collaborative WHEATBIOME project, over a 4-week intervention period in healthy adults.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ana Faria
- Telefonnummer: +351218803000
- E-mail: ana.faria@nms.unl.pt
Studiesteder
-
-
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Lisbon, Portugal
- NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
-
Kontakt:
- Ana Faria
- Telefonnummer: +351218803000
- E-mail: ana.faria@nms.unl.pt
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Healthy status
- Willingness to consume a fermented wheat-based beverage daily for 4 weeks
- Capacity and willingness to provide written informed consent
Exclusion Criteria:
- Use of antibiotics and/or probiotics in the 12 weeks prior to the study
- Weight variation >10% within the last 3 months
- Participation in any clinical study or trial within the previous 12 months
- Diagnosed medical conditions, including: diabetes, liver disease (e.g., cirrhosis), pancreatitis or other malabsorption syndromes, gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease), history of weight-loss surgery (e.g., bariatric surgery), chronic respiratory, neurological, psychiatric, musculoskeletal, or other systemic conditions, eating disorders
- Diagnosed food allergies or intolerances
- Pregnancy or breastfeeding
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Wheat-based fermented beverage (developed under the WHEATBIOME project)
|
Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gut microbiota
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in gut microbiota from baseline.
Microbial DNA will be extracted from faecal samples and sequenced by shotgun metagenomics.
All the identified bacterial phyla, genus and species will be expressed in percentage.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Oral microbiota
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in oral microbiota from baseline.
Microbial DNA will be extracted from buccal swabs and sequenced by shotgun metagenomics.
All the identified bacterial phyla, genus and species will be expressed in percentage.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Fasting blood glucose
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Insulin
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in insulin levels (μU/mL) levels from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Total cholesterol
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in total cholesterol levels (mg/dL) from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
LDL cholesterol
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Triacylglycerides
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in triacylglycerides (mg/dL) levels from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Exhaled breath gas profile
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in exhaled methane and hydrogen represented in parts per million (ppm) from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in weight (kg) from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Body fat mass
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in percentage of body fat mass from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Gastrointestinal quality of life
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in gastrointestinal quality of life by the Gastrointestinal Quality of Life Index (GIQLI) questionnaire from baseline.
The GIQLI is a 36 -item questionnaire and consists of 5 different subscales.
The total score is calculated as the sum of the 36 items each ranged from 0 to 4. The final score range from 0 to 144 points (lower scores indicate more unfavorable conditions).
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
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Interleukin-6
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in interleukin-6 (pg/mL) from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
|
Tumor Necrosis Factor-alpha
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Changes in Tumor Necrosis Factor-alpha (pg/mL) from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
20. maj 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
17. april 2026
Først indsendt, der opfyldte QC-kriterier
27. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- WHEATBIOME
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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