Clinical trial NCT02215343: Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers
Official title: Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: http://mynewgut.eu/partners
First posted: 2014-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in gut microbiota composition
timeFrame: Week 0, 4, 8, 12
Secondary outcomes:
measure: Change in markers for insulin sensitivity
timeFrame: Week 0, 4, 8, 12
measure: Change in markers for lipid metabolism
timeFrame: Week 0, 4, 8, 12
measure: Change in markers for inflammation
timeFrame: Week 0, 4, 8, 12
measure: Faecal SCFA and bile acid composition
timeFrame: Week 0, 4, 8, 12
measure: Lipidomics
timeFrame: Week 0, 4, 8, 12
measure: Metabolomics
timeFrame: Week 0, 4, 8, 12
Other outcomes:
measure: Change in energy expenditure
timeFrame: Week 0, 4, 8, 12
measure: Gene expression
timeFrame: Week 0, 4, 8, 12
measure: Compliances markers
timeFrame: Week 0, 4, 8, 12
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Lesli H Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.