Glucose MetabolismSIMBANCT04120051
The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults
A study testing Fermented canola-seaweed in people with Glucose Metabolism and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism, Metabolic Syndrome, Gut Microbiota
- What is being tested?
- Fermented canola-seaweed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Oct 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who have provided written informed consent
- Age between 30 and 65 years
- Body mass index ≥31 kg/m^2
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen
Frederiksberg, Danmark, 2000
Mads Lind, PhD, 004535331091, madslind@nexs.ku.dk
About this study
Official title: The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota
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.
Read the 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.
- Conditions
- Glucose Metabolism, Metabolic Syndrome, Gut Microbiota
- Being tested
- Fermented canola-seaweed, Placebo
- Keywords
- Gut Microbiota, Metabolic syndrome, Obesity, Supplement
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented canola-seaweedDietary supplement
A daily sachet with 5 gram FCS-granulate for 6 weeks
PlaceboOther
A daily sachet with 5 gram rye cereal for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fermented canola-seaweed supplement | Experimental | Ingredients: Canola meal, seaweed, wheat, glucose, Vitamin D and lactic acid bacteria Receives: Dietary Supplement: Fermented canola-seaweed |
| Placebo | Placebo comparator | Ingredients: Rye flour, water, iodized salt, brown sugar Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in 2-h post-OGTT glucose in blood between baseline and endpoint
2 hour post oral glucose tolerance test glucose measurement in blood (mmol/L)
Measured: Week 0 and Week 6
Secondary outcomes (16)
Changes in Hba1c between baseline and endpoint
fasting measurement of blood glycated hemoglobin (%)
Measured: Week 0 and Week 6
Changes in fasting blood glucose between baseline and endpoint
Fasting measurement of blood glucose (mmol/L)
Measured: Week 0 and Week 6
Changes in 30 min post OGTT between baseline and endpoint
Measurement of blood glucose 30 min after OGTT (mmol/L)
Measured: Week 0 and Week 6
Insulin sensitivity and secretion
Measured as part of the OGTT. Plasma glucose (mmol/l). Plasma insulin - fasting (pmol/l)
Measured: Week 0 and Week 6
Changes in blood lipids between baseline and endpoint
Measurements of total and HDL cholesterol (mmol/L) and triglycerides (mmol/L)
Measured: Week 0 and Week 6
Changes in C-Reactive Protein between baseline and endpoint
Blood measurements of C-Reactive Protein (mg/L)
Measured: Week 0 and Week 6
Changes in Interleukin-6 between baseline and endpoint
Blood measurements of Interleukin-6 (pg/mL)
Measured: Week 0 and Week 6
Changes in small metabolites between baseline and endpoint
Measured using blood metabolomic measurements of amino acids, lipids, and other small metabolites (umol/L)
Measured: Week 0 and Week 6
Changes in weight between baseline and endpoint
Measured using a Tanita body composition analyser. Body weight in kilograms
Measured: Week 0 and Week 6
Changes in waist circumference between baseline and endpoint
Measured using measurement tape
Measured: Week 0 and Week 6
Changes in body composition between baseline and endpoint
Measured using a Tanita body composition analyser. Fat free mass and Body fat mass in kilograms used to calculate body fat percentage.
Measured: Week 0 and Week 6
Changes in blood pressure (BP) between baseline and endpoint
Systolic BP (mmHG) Diastolic BP (mmHG)
Measured: Week 0 and Week 6
Continuous glucose monitoring
Continuous glucose monitor from Abbott is worn for 14 days in each period providing glucose measurements continuously (mmol/L)
Measured: Week 0
Changes in Liver function markers
Alanine transaminase (ALAT) (U/L), Aspartate transaminase (ASAT) (U/L)
Measured: Week 0 and week 6
Changes in circulating endotoxin/lipopolysaccharide (LPS) concentrations
LPS (pg/ml)
Measured: Week 0 and Week 6
Changes in gut microbiota composition
Measured on fecal samples
Measured: Week 0 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start28 Oct 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose MetabolismStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- FermBiotics ApS
- Responsible party
- Principal investigator, Mads Vendelbo Lind, University of Copenhagen
- Investigators
- Mads V Lind, PhD, Principal investigator, University of Copenhagen, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120051
- Sponsor's protocol ID
- H-19041432
- Acronym
- SIMBA
- Status last verified
- Nov 2019
- First submitted
- 7 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota
- ClinicalTrials.gov ID
- NCT04120051
- Acronym / sponsor ID
- SIMBA / H-19041432
- Conditions
- Glucose Metabolism, Metabolic Syndrome, Gut Microbiota
- Keywords
- Gut Microbiota, Metabolic syndrome, Obesity, Supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- FermBiotics ApS
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Fermented canola-seaweed supplement | Experimental | Dietary Supplement: Fermented canola-seaweedIngredients: Canola meal, seaweed, wheat, glucose, Vitamin D and lactic acid bacteria |
| Placebo | Placebo comparator | Other: PlaceboIngredients: Rye flour, water, iodized salt, brown sugar |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who have provided written informed consent
- Age between 30 and 65 years
- Body mass index ≥31 kg/m^2
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented canola-seaweedA daily sachet with 5 gram FCS-granulate for 6 weeks | Dietary supplement | Fermented canola-seaweed supplement |
| PlaceboA daily sachet with 5 gram rye cereal for 6 weeks | Other | Placebo |
Primary outcome
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)
16 secondary outcomes
Changes in Hba1c between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in fasting blood glucose between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in 30 min post OGTT between baseline and endpoint
Time frame: Week 0 and Week 6
Insulin sensitivity and secretion
Time frame: Week 0 and Week 6
Changes in blood lipids between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in C-Reactive Protein between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in Interleukin-6 between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in small metabolites between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in weight between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in waist circumference between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in body composition between baseline and endpoint
Time frame: Week 0 and Week 6
Changes in blood pressure (BP) between baseline and endpoint
Time frame: Week 0 and Week 6
Continuous glucose monitoring
Time frame: Week 0
Changes in Liver function markers
Time frame: Week 0 and week 6
Changes in circulating endotoxin/lipopolysaccharide (LPS) concentrations
Time frame: Week 0 and Week 6
Changes in gut microbiota composition
Time frame: Week 0 and Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mads V Lind, PhD principal investigator
University of Copenhagen, Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented canola-seaweed in people with Glucose Metabolism and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mads V Lind, PhD (35 33 10 91 ext. +45, madslind@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in 2-h post-OGTT glucose in blood between baseline and endpoint (time frame: Week 0 and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.