- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02491125
The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
4. juli 2019 oppdatert av: Maastricht University Medical Center
Effect of Prebiotic Fibre on Intestinal Health and Functioning
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Ikke aktuelt
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
20 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
- Aged 20-50 years
- Caucasian
- Normal fasting glucose (<6.1 mmol/L.)
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- Weight stable in last 3 months (±2 kg)
- A low defecation frequency, <4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
- A slow whole gut transit (>35h)
Exclusion Criteria:
- Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
- Regular smokers
- People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
- Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
- Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
- Following a hypocaloric diet
- Gluten intolerance
- Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
- Straining in >1/4 defecations;
- Lumpy or hard stools in >1/4 defecations;
- Sensation of incomplete evacuation in >1/4 defecations;
- Sensation of anorectal obstruction/blockade in >1/4 defecations
- Manual maneuvers to facilitate >1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
- <3 defecations/week
- Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
- Not to be able to understand the study information
- Blood donation 2 months prior to the study and during the study
- Participation in other studies
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)
|
12 weeks daily intake of 15g of maltodextrin
Andre navn:
|
Eksperimentell: soluble wheat bran fibre
12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)
|
12 weeks daily intake of 15g of soluble wheat bran fibre
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Whole gut transit time [hours]
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Whole gut transit time as measured by radio-opaque marker method
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Gastric emptying [min]
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Gastric emptying measured by isotope breath test
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Oro-cecal transit time [min]
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Oro-cecal transit time measured by hydrogen breath test
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Defecation frequency (bowel movement per day)
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Defecation frequency as measured via questionnaire
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Energy expenditure
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Energy expenditure measured by indirect calorimetry
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Substrate oxidation
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Fat and carbohydrate oxidation measured by indirect calorimetry
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Adipose tissue gene expression
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Adipose tissue gene expression measured by quantitative real time polymerase chain reaction
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Gut permeability
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Gut permeability as measured by multi sugar assay
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Microbiota composition
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Microbiota composition as measured by illumina sequencing in feces
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Fecal Short chain fatty acid concentrations
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Plasma short chain fatty acid concentrations
Tidsramme: measured at baseline at week 1 and directly after the 12 week supplementation
|
Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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
1. juli 2015
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
23. mars 2015
Først innsendt som oppfylte QC-kriteriene
1. juli 2015
Først lagt ut (Anslag)
7. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juli 2019
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NL52300.068.15
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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