Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
27. april 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ana Faria
- Telefonnummer: +351218803000
- E-post: ana.faria@nms.unl.pt
Studiesteder
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Lisbon, Portugal
- NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
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Ta kontakt med:
- Ana Faria
- Telefonnummer: +351218803000
- E-post: ana.faria@nms.unl.pt
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention
Wheat-based fermented beverage (developed under the WHEATBIOME project)
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Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gut microbiota
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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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)
|
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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)
|
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Fasting blood glucose
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in fasting blood glucose levels (mg/dL) levels from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
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Insulin
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in insulin levels (μU/mL) levels from baseline.
|
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
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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)
|
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LDL cholesterol
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
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Triacylglycerides
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in triacylglycerides (mg/dL) levels from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Exhaled breath gas profile
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in exhaled methane and hydrogen represented in parts per million (ppm) from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Weight
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in weight (kg) from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Body fat mass
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in percentage of body fat mass from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
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Gastrointestinal quality of life
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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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)
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Changes in interleukin-6 (pg/mL) from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
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Tumor Necrosis Factor-alpha
Tidsramme: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
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Changes in Tumor Necrosis Factor-alpha (pg/mL) from baseline.
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At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
20. mai 2026
Primær fullføring (Antatt)
1. august 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
17. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
1. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- WHEATBIOME
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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