Status:
UNKNOWN
The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
FermBiotics ApS
Conditions:
Glucose Metabolism
Metabolic Syndrome
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
Modulation of the gut microbiota via administration of pro- and prebiotics have been proposed to contribute to weight loss and reduce plasma glucose and serum lipid levels, improving the inflammatory ...
Detailed Description
The overall objective of this study is to investigate a fermented canola-seaweed (FCS) product in obese human subjects with increased risk of metabolic syndrome (MS). We will study the effects of the ...
Eligibility Criteria
Inclusion
- Participants who have provided written informed consent
- Age between 30 and 65 years
- Body mass index ≥31 kg/m\^2
Exclusion
- Body mass index \<31 kg/m\^2
- Diagnosis of diabetes (HbA1c ≥ 6,5% (48 mmol/mol)) or pharmacological treatment of diabetes
- Use of peroral glucocorticoids
- Lack of compliance with the procedures (ingestion of sachets) in the study protocol, judged by Investigator
- Ingestion of pre- or probiotic supplements during the study and 14 days prior to study start
- Use of systemic antibiotics 1 month prior to study start
- Use of cholesterol lowering drugs
- Have had an obesity or abdominal surgery
- Chronic inflammation disorders (excluding obesity)
- Diagnosed psychiatric disorder including depression requiring treatment
- Gastro intestinal and liver disorders
- Gluten intolerance
- Maltodextrin intolerance
- Intensive physical training/ elite athlete (\>10 hours of strenuous physical activity per week)
- Pregnant or lactating
- High intake of alcohol (\>14 drinks/week for women and \>21 drinks/week for men)
- Simultaneous blood donation for other purpose than this study
- Simultaneous participation in other clinical intervention studies
- Inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the principal investigator or clinical responsible.
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04120051
Start Date
October 28 2019
End Date
March 31 2020
Last Update
November 5 2019
Active Locations (1)
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1
University of Copenhagen
Frederiksberg, Danmark, Denmark, 2000