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- Klinische proef NCT02215343
Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers (MyNewGut)
Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population
The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.
Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Frederiksberg, Denemarken, 1958
- Department of Nutrition, Exercise and Sports, University of Copenhagen
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- BMI: 25-40 kg/m2
- Non-smoking
- Indices of the Metabolic Syndrome defined by the International Diabetes Federation (IDF 2006):
Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: <1.03 mmol/L, women: <1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or raised fasting plasma glucose (≥5.6 mmol/L).
Exclusion Criteria:
- Use of antibiotics
- Weight change >3 kg 2 months prior to study start
- Intensive physical training/ elite athlete
- Medication for dyslipidemia, type 2 diabetes or elevated blood pressure
- Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement
- Lactation, pregnancy or planning of pregnancy during the study
- Gastro intestinal and liver disorders
- Chronic inflammatory disorders
- Diagnosed psychiatric disorder including treatment required depression
- Surgical treatment of obesity and abdominal surgery
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: High fibre diet (wheat bran extract)
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Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
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Experimenteel: High PUFA diet (fish oil supplement)
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Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in gut microbiota composition
Tijdsspanne: Week 0, 4, 8, 12
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Gut microbiota composition will be analyzed by use of fecal samples.
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Week 0, 4, 8, 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in markers for insulin sensitivity
Tijdsspanne: Week 0, 4, 8, 12
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Will be measured by use of fasting blood samples
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Week 0, 4, 8, 12
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Change in markers for lipid metabolism
Tijdsspanne: Week 0, 4, 8, 12
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Will be measured by use of fasting blood samples
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Week 0, 4, 8, 12
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Change in markers for inflammation
Tijdsspanne: Week 0, 4, 8, 12
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Will be measured by use of fasting blood samples
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Week 0, 4, 8, 12
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Faecal SCFA and bile acid composition
Tijdsspanne: Week 0, 4, 8, 12
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Will be analyzed by use of fecal samples.
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Week 0, 4, 8, 12
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Lipidomics
Tijdsspanne: Week 0, 4, 8, 12
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Will be analyzed by use of fasting blood samples and fecal samples.
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Week 0, 4, 8, 12
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Metabolomics
Tijdsspanne: Week 0, 4, 8, 12
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Will be analyzed by use of fasting blood samples, urine and fecal samples.
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Week 0, 4, 8, 12
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in energy expenditure
Tijdsspanne: Week 0, 4, 8, 12
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Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system
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Week 0, 4, 8, 12
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Gene expression
Tijdsspanne: Week 0, 4, 8, 12
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Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).
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Week 0, 4, 8, 12
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Compliances markers
Tijdsspanne: Week 0, 4, 8, 12
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Compliance will be evaluated from 3-days diet registration and self-reported intake of dietary supplements, PUFA complance markes (fatty acid composition) and body composition
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Week 0, 4, 8, 12
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Lesli H Larsen, PhD, Department of Nutrition, Exercise and Sports, University of Copenhagen
Publicaties en nuttige links
Algemene publicaties
- Benitez-Paez A, Kjolbaek L, Gomez Del Pulgar EM, Brahe LK, Astrup A, Matysik S, Schott HF, Krautbauer S, Liebisch G, Boberska J, Claus S, Rampelli S, Brigidi P, Larsen LH, Sanz Y. A Multi-omics Approach to Unraveling the Microbiome-Mediated Effects of Arabinoxylan Oligosaccharides in Overweight Humans. mSystems. 2019 May 28;4(4):e00209-19. doi: 10.1128/mSystems.00209-19.
- Kjolbaek L, Benitez-Paez A, Gomez Del Pulgar EM, Brahe LK, Liebisch G, Matysik S, Rampelli S, Vermeiren J, Brigidi P, Larsen LH, Astrup A, Sanz Y. Arabinoxylan oligosaccharides and polyunsaturated fatty acid effects on gut microbiota and metabolic markers in overweight individuals with signs of metabolic syndrome: A randomized cross-over trial. Clin Nutr. 2020 Jan;39(1):67-79. doi: 10.1016/j.clnu.2019.01.012. Epub 2019 Feb 19.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MyNewGut, Task 3.3
- Grant Agreement no: 613979 (Ander subsidie-/financieringsnummer: EU 7th Framework Programme)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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