Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-05-27 @ 1:51 PM
Study NCT ID:
NCT04120051
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2019-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMBA
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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: