The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
4 luglio 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
48
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 50 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: 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
Altri nomi:
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Whole gut transit time [hours]
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Gastric emptying [min]
Lasso di tempo: 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]
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2015
Completamento primario (Effettivo)
1 dicembre 2016
Completamento dello studio (Effettivo)
1 dicembre 2016
Date di iscrizione allo studio
Primo inviato
23 marzo 2015
Primo inviato che soddisfa i criteri di controllo qualità
1 luglio 2015
Primo Inserito (Stima)
7 luglio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 luglio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 luglio 2019
Ultimo verificato
1 ottobre 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NL52300.068.15
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .