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The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults (SIMBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120051
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
FermBiotics ApS
Information provided by (Responsible Party):
Mads Vendelbo Lind, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Glucose Metabolism Metabolic Syndrome Gut Microbiota Dietary Supplement: Fermented canola-seaweed Other: Placebo Not Applicable

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:

After having given oral and written consent, randomization will be performed separately for each participant in blocks of variable size to ensure equal randomization throughout the enrolment phase of the study. 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.

Examinations:

Participants will arrive for clinical examination after an overnight fast of at least 8 hours. Lifestyle questionnaires and questionnaires about medication use will be performed for baseline characterization of the participants. Blood pressure and anthropometric measurements are performed including measurements of body weight, height, waist and hip circumference, and bio-impedance measurements for assessing body fat mass. A fasting blood sample is obtained and an oral glucose tolerance test (OGTT) is performed with collection of blood samples after 0, 30 and 120 min. Samples will be analyzed with standard clinical procedures for glycaemic variability markers, including glucose, insulin, c-peptide, and HbA1c, as well as plasma lipids. Furthermore, fecal samples will be collected at both examination visits and kept stored for future microbiota analyses, using untargeted shotgun sequencing.

Samples in biobank will be stored for further analyses, which could include gastrointestinal hormones, gut microbiota metabolites, blood, and fecal metabolome and low-grade inflammation markers. In addition, a subgroup of participants (10 in each group) will be equipped with a 24-h continuous glucose monitoring device for 14 days at the start of the intervention period. Both examination days consists of similar examinations and data collections and are estimated to last approximately 2½ hours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants will be randomized to the Fermented Canola-Seaweed supplement or control and are expected to consume one sachet (5 grams) of either every day for 6 weeks
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
Primary Purpose: Other
Official Title: The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fermented canola-seaweed supplement
Ingredients: Canola meal, seaweed, wheat, glucose, Vitamin D and lactic acid bacteria
Dietary Supplement: Fermented canola-seaweed
A daily sachet with 5 gram FCS-granulate for 6 weeks

Placebo Comparator: Placebo
Ingredients: Rye flour, water, iodized salt, brown sugar
Other: Placebo
A daily sachet with 5 gram rye cereal for 6 weeks




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in Hba1c between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    fasting measurement of blood glycated hemoglobin (%)

  2. Changes in fasting blood glucose between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Fasting measurement of blood glucose (mmol/L)

  3. Changes in 30 min post OGTT between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Measurement of blood glucose 30 min after OGTT (mmol/L)

  4. Insulin sensitivity and secretion [ Time Frame: Week 0 and Week 6 ]
    Measured as part of the OGTT. Plasma glucose (mmol/l). Plasma insulin - fasting (pmol/l)

  5. Changes in blood lipids between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Measurements of total and HDL cholesterol (mmol/L) and triglycerides (mmol/L)

  6. Changes in C-Reactive Protein between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Blood measurements of C-Reactive Protein (mg/L)

  7. Changes in Interleukin-6 between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Blood measurements of Interleukin-6 (pg/mL)

  8. Changes in small metabolites between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Measured using blood metabolomic measurements of amino acids, lipids, and other small metabolites (umol/L)

  9. Changes in weight between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Measured using a Tanita body composition analyser. Body weight in kilograms

  10. Changes in waist circumference between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Measured using measurement tape

  11. Changes in body composition between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Measured using a Tanita body composition analyser. Fat free mass and Body fat mass in kilograms used to calculate body fat percentage.

  12. Changes in blood pressure (BP) between baseline and endpoint [ Time Frame: Week 0 and Week 6 ]
    Systolic BP (mmHG) Diastolic BP (mmHG)

  13. Continuous glucose monitoring [ Time Frame: Week 0 ]
    Continuous glucose monitor from Abbott is worn for 14 days in each period providing glucose measurements continuously (mmol/L)

  14. Changes in Liver function markers [ Time Frame: Week 0 and week 6 ]
    Alanine transaminase (ALAT) (U/L), Aspartate transaminase (ASAT) (U/L)

  15. Changes in circulating endotoxin/lipopolysaccharide (LPS) concentrations [ Time Frame: Week 0 and Week 6 ]
    LPS (pg/ml)

  16. Changes in gut microbiota composition [ Time Frame: Week 0 and Week 6 ]
    Measured on fecal samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120051


Contacts
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Contact: Mads V Lind, PhD 35 33 10 91 ext +45 madslind@nexs.ku.dk
Contact: Dennis S Nielsen, PhD 35 33 32 87 ext +45 dn@food.ku.dk

Locations
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Denmark
University of Copenhagen Recruiting
Frederiksberg, Danmark, Denmark, 2000
Contact: Mads Lind, PhD    004535331091    madslind@nexs.ku.dk   
Sponsors and Collaborators
University of Copenhagen
FermBiotics ApS
Investigators
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Principal Investigator: Mads V Lind, PhD University of Copenhagen, Department of Nutrition, Exercise and Sports

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Responsible Party: Mads Vendelbo Lind, Post doc, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04120051    
Other Study ID Numbers: H-19041432
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mads Vendelbo Lind, University of Copenhagen:
Gut Microbiota
Metabolic syndrome
Obesity
Supplement
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases