The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Copenhagen
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- changes in 2-h post-OGTT glucose in blood between baseline and endpoint
Study Overview
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 state and decreasing the incidence of type 2 diabetes and cardiovascular disease. This study will test a fermented canola-seaweed (FCS) product, high in glucosinolates and putatively prebiotic oligosaccharides, in human subjects with obesity.
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 FCS on glucose handling and related cardiometabolic traits such as dyslipidemia and low-grade systemic inflammation. Finally, we will examine the gut microbiota and the metabolic phenotype of the subjects to explore molecular mechanisms related to the potential improvements.
It is hypothesized that the FCS product will improve postprandial glucose handling, blood lipids and low-grade inflammation in obese subjects with increased risk of MS. Furthermore, it is hypothesized that this effect is modified through gut microbiota compositional and functionality changes
Methods:
This study will be conducted as a randomized, controlled, investigator and participant blinded intervention trial. The participants will be randomized to the FCS supplement or control and are expected to consume one sachet of either every day for 6 weeks.
Randomization, blinding and allocation concealment:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The randomization sequence will be done by an investigator without contact to the participants. The personnel conducting the study will allocate participants to the sequence of intervention using a list of participant identification numbers matched with allocated sequences. The participants will be blinded to the intervention and blinding of the allocation sequence will be present for investigators during sample analysis and initial data analysis
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who have provided written informed consent
- •Age between 30 and 65 years
- •Body mass index ≥31 kg/m^2
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
changes in 2-h post-OGTT glucose in blood between baseline and endpoint
Time Frame: Week 0 and Week 6
2 hour post oral glucose tolerance test glucose measurement in blood (mmol/L)
Secondary Outcomes
- Changes in body composition between baseline and endpoint(Week 0 and Week 6)
- Changes in Hba1c between baseline and endpoint(Week 0 and Week 6)
- Changes in blood lipids between baseline and endpoint(Week 0 and Week 6)
- Changes in small metabolites between baseline and endpoint(Week 0 and Week 6)
- Changes in Liver function markers(Week 0 and week 6)
- Changes in circulating endotoxin/lipopolysaccharide (LPS) concentrations(Week 0 and Week 6)
- Changes in fasting blood glucose between baseline and endpoint(Week 0 and Week 6)
- Changes in 30 min post OGTT between baseline and endpoint(Week 0 and Week 6)
- Changes in Interleukin-6 between baseline and endpoint(Week 0 and Week 6)
- Changes in weight between baseline and endpoint(Week 0 and Week 6)
- Changes in blood pressure (BP) between baseline and endpoint(Week 0 and Week 6)
- Changes in waist circumference between baseline and endpoint(Week 0 and Week 6)
- Continuous glucose monitoring(Week 0)
- Changes in gut microbiota composition(Week 0 and Week 6)
- Insulin sensitivity and secretion(Week 0 and Week 6)
- Changes in C-Reactive Protein between baseline and endpoint(Week 0 and Week 6)
Investigators
Mads Vendelbo Lind
Post doc
University of Copenhagen