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

NCT04120051 | Unknown

• 1 other identifier: H-19041432
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism; Metabolic Syndrome; Gut Microbiota

Keywords

Gut Microbiota; Metabolic syndrome; Obesity; Supplement

Outcome Measures

Primary Outcomes (1)

• 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)

  Week 0 and Week 6

Secondary Outcomes (16)

• Changes in Hba1c between baseline and endpoint

  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

• Insulin sensitivity and secretion

  Week 0 and Week 6

• Changes in blood lipids between baseline and endpoint

  Week 0 and Week 6

Study Arms (2)

Fermented canola-seaweed supplement

EXPERIMENTAL

Ingredients: Canola meal, seaweed, wheat, glucose, Vitamin D and lactic acid bacteria

Dietary Supplement: Fermented canola-seaweed

Placebo

PLACEBO COMPARATOR

Ingredients: Rye flour, water, iodized salt, brown sugar

Other: Placebo

Interventions

Fermented canola-seaweed DIETARY_SUPPLEMENT

A daily sachet with 5 gram FCS-granulate for 6 weeks

Fermented canola-seaweed supplement

Placebo OTHER

A daily sachet with 5 gram rye cereal for 6 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have provided written informed consent
• Age between 30 and 65 years
• Body mass index ≥31 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• FermBiotics ApS: collaborator

Study Sites (1)

University of Copenhagen

Frederiksberg, Danmark, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mads V Lind, PhD

  University of Copenhagen, Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mads V Lind, PhD

CONTACT

35 33 10 91; madslind@nexs.ku.dk

Dennis S Nielsen, PhD

CONTACT

35 33 32 87; dn@food.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doc

Model Details: 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

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: October 28, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)