Back to resultsFiber and Insulin Sensitivity
Primary Purpose
Obesity, Insulin Resistance
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Placebo
Whole fiber product
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
Inclusion criteria:
Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 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.
- Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
- The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
- Claustrophobia
Sites / Locations
- Maastricht UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
whole fiber product
Arm Description
isocaloric placebo
15 g for 2 weeks, followed by 30 g for 10 weeks
Outcomes
Primary Outcome Measures
Peripheral insulin sensitivity
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Secondary Outcome Measures
hepatic and adipose tissue insulin sensitivity
The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
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
Faecal and circulating SCFA
The change in faecal and circulating SCFA
Faecal microbiota composition and in vitro microbial activity testing
The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing
In vitro microbial activity testing
The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon
Circulating hormones such as insulin
The change in circulating hormones in peripheral blood
Circulating metabolites such as glucose
The change in metabolites in peripheral blood
Circulating inflammatory markers such as TNF
The change in inflammatory markers in peripheral blood
body weight
The change in body weight in kg
body composition
The change in body compostion as assessed using DEXA scans
liver fat content
The change in liver fat content as assessed by proton magnetic resonance spectrometry
Full Information
NCT ID
NCT04714944
First Posted
December 4, 2020
Last Updated
May 18, 2022
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04714944
Brief Title
Fiber and Insulin Sensitivity
Official Title
Gut Microbial Substrate Switch to Improve Metabolic Health
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (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
Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.
The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
isocaloric placebo
Arm Title
whole fiber product
Arm Type
Experimental
Arm Description
15 g for 2 weeks, followed by 30 g for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Supplementation period 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole fiber product
Intervention Description
Supplementation period 12 weeks
Primary Outcome Measure Information:
Title
Peripheral insulin sensitivity
Description
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time Frame
Before and 12 week after the start of the intervention
Secondary Outcome Measure Information:
Title
hepatic and adipose tissue insulin sensitivity
Description
The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time Frame
Before and 12 week after the start of the intervention
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
Faecal and circulating SCFA
Description
The change in faecal and circulating 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 as assessed via 16s rRNA gene sequencing
Time Frame
Before and 12 week after the start of the intervention
Title
In vitro microbial activity testing
Description
The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon
Time Frame
Before and 12 week after the start of the intervention
Title
Circulating hormones such as insulin
Description
The change in 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 metabolites in peripheral blood
Time Frame
Before and 12 week after the start of the intervention
Title
Circulating inflammatory markers such as TNF
Description
The change in inflammatory markers in peripheral blood
Time Frame
Before and 12 week after the start of the intervention
Title
body weight
Description
The change in body weight in kg
Time Frame
Before and 12 week after the start of the intervention
Title
body composition
Description
The change in body compostion as assessed using DEXA scans
Time Frame
Before and 12 week after the start of the intervention
Title
liver fat content
Description
The change in liver fat content as assessed by proton magnetic resonance spectrometry
Time Frame
Before and 12 week after the start of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 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.
Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
Claustrophobia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuel 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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Fiber and Insulin Sensitivity
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