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
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 20, 2020
May 1, 2020
10 months
July 15, 2014
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in gut microbiota composition
Gut microbiota composition will be analyzed by use of fecal samples.
Week 0, 4, 8, 12
Secondary Outcomes (6)
Change in markers for insulin sensitivity
Week 0, 4, 8, 12
Change in markers for lipid metabolism
Week 0, 4, 8, 12
Change in markers for inflammation
Week 0, 4, 8, 12
Faecal SCFA and bile acid composition
Week 0, 4, 8, 12
Lipidomics
Week 0, 4, 8, 12
- +1 more secondary outcomes
Other Outcomes (3)
Change in energy expenditure
Week 0, 4, 8, 12
Gene expression
Week 0, 4, 8, 12
Compliances markers
Week 0, 4, 8, 12
Study Arms (2)
High fibre diet (wheat bran extract)
EXPERIMENTALHigh PUFA diet (fish oil supplement)
EXPERIMENTALInterventions
Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R\&D Centre Europe).
Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- http://mynewgut.eu/partnerscollaborator
Study Sites (1)
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, 1958, Denmark
Related Publications (2)
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.
PMID: 31138673DERIVEDKjolbaek 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.
PMID: 30827722DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lesli H Larsen, PhD
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Dr.Med.
Study Record Dates
First Submitted
July 15, 2014
First Posted
August 13, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 20, 2020
Record last verified: 2020-05