Back to resultsPersonalized Fiber and Insulin Sensitivity
Primary Purpose
Type 2 Diabetes, Insulin Resistance
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fermentable oligosaccharide
Personalized fiber mixture
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 < 40 kg/m2)
Exclusion Criteria:
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
- Plans to lose weight or following of a hypocaloric diet;
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
- Intensive exercise training more than three hours a week;
- Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
- Regular use of laxation products;
- Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- Follow a vegetarian diet.
Sites / Locations
- Maastricht UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
isocaloric fermentable oligosaccaride
Personalized fiber mixture
Arm Description
isocaloric fermentable oligosaccaride
12 g for 2 weeks, followed by 24 g for 10 weeks
Outcomes
Primary Outcome Measures
Peripheral insulin sensitivity
The change of peripheral insulin sensitivity (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp
Secondary Outcome Measures
Energy expenditure (indirect calorimetry)
The change in energy expenditure as measured via ventilated hood system
Substrate oxidation (indirect calorimetry)
The change in substrate oxidation as measured via ventilated hood system
circulating SCFA
The change in concentrations of circulating SCFA
Faecal SCFA
The change in concentrations of faecal SCFA
Faecal microbiota composition and in vitro microbial activity testing
The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene
Circulating hormones such as insulin
The change in concentrations of circulating hormones in peripheral blood
Circulating metabolites such as glucose
The change in concentrations of metabolites in peripheral blood
body fat percentage
The change in body fat percentage as assessed using DEXA scans
fat mass
The change in fat mass in kg as assessed using DEXA scans
lean mass
The change in lean mass in kg as assessed using DEXA scans
visceral fat
The change in visceral fat in gram as assessed using DEXA scans
body weight
The change in body weight in kg using a weight scale
Full Information
NCT ID
NCT05378295
First Posted
May 12, 2022
Last Updated
May 31, 2022
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05378295
Brief Title
Personalized Fiber and Insulin Sensitivity
Official Title
Personalized Microbial Substrates to Prevent Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:
To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals;
To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
isocaloric fermentable oligosaccaride
Arm Type
Active Comparator
Arm Description
isocaloric fermentable oligosaccaride
Arm Title
Personalized fiber mixture
Arm Type
Experimental
Arm Description
12 g for 2 weeks, followed by 24 g for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermentable oligosaccharide
Intervention Description
Supplementation period 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Personalized fiber mixture
Intervention Description
Supplementation period 12 weeks
Primary Outcome Measure Information:
Title
Peripheral insulin sensitivity
Description
The change of peripheral insulin sensitivity (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp
Time Frame
Before and 12 week after the start of the intervention
Secondary Outcome Measure Information:
Title
Energy expenditure (indirect calorimetry)
Description
The change in energy expenditure as measured via ventilated hood system
Time Frame
Before and 12 week after the start of the intervention
Title
Substrate oxidation (indirect calorimetry)
Description
The change in substrate oxidation as measured via ventilated hood system
Time Frame
Before and 12 week after the start of the intervention
Title
circulating SCFA
Description
The change in concentrations of circulating SCFA
Time Frame
Before and 12 week after the start of the intervention
Title
Faecal SCFA
Description
The change in concentrations of faecal SCFA
Time Frame
Before and 12 week after the start of the intervention
Title
Faecal microbiota composition and in vitro microbial activity testing
Description
The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene
Time Frame
Before and 12 week after the start of the intervention
Title
Circulating hormones such as insulin
Description
The change in concentrations of circulating hormones in peripheral blood
Time Frame
Before and 12 week after the start of the intervention
Title
Circulating metabolites such as glucose
Description
The change in concentrations of metabolites in peripheral blood
Time Frame
Before and 12 week after the start of the intervention
Title
body fat percentage
Description
The change in body fat percentage as assessed using DEXA scans
Time Frame
Before and 12 week after the start of the intervention
Title
fat mass
Description
The change in fat mass in kg as assessed using DEXA scans
Time Frame
Before and 12 week after the start of the intervention
Title
lean mass
Description
The change in lean mass in kg as assessed using DEXA scans
Time Frame
Before and 12 week after the start of the intervention
Title
visceral fat
Description
The change in visceral fat in gram as assessed using DEXA scans
Time Frame
Before and 12 week after the start of the intervention
Title
body weight
Description
The change in body weight in kg using a weight scale
Time Frame
Before and 12 week after the start of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 < 40 kg/m2)
Exclusion Criteria:
Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
Gastroenterological diseases or abdominal surgery;
Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
Plans to lose weight or following of a hypocaloric diet;
Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
Intensive exercise training more than three hours a week;
Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
Regular use of laxation products;
Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
Follow a vegetarian diet.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuel E Canfora, PhD
Phone
+31-43 38 81669
Email
emanuel.canfora@maastrichtuniversity.nl
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
5229ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuel Canfora, PhD
Phone
+31-43 38 81669
Email
emanuel.canfora@maastrichtuniversity.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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