Fiber and Insulin Sensitivity

Gut Microbial Substrate Switch to Improve Metabolic Health

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Whole fiber product

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emanuel Canfora, PhD; Phone Number: +31-43 38 81669; Email: emanuel.canfora@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 5229ER
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; isocaloric placebo	Dietary supplement: Placebo; Supplementation period 12 weeks
Experimental: whole fiber product; 15 g for 2 weeks, followed by 30 g for 10 weeks	Dietary supplement: Whole fiber product; Supplementation period 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral insulin sensitivity	The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 12 week after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure (indirect calorimetry)	The change in energy expenditure as measured via ventilated hood system	Before and 12 week after the start of the intervention
Substrate oxidation (indirect calorimetry)	The change in substrate oxidation as measured via ventilated hood system	Before and 12 week after the start of the intervention
hepatic and adipose tissue insulin sensitivity	The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 12 week after the start of the intervention
Faecal and circulating SCFA	The change in faecal and circulating SCFA	Before and 12 week after the start of the intervention
Faecal microbiota composition and in vitro microbial activity testing	The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing	Before and 12 week after the start of the intervention
In vitro microbial activity testing	The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon	Before and 12 week after the start of the intervention
Circulating hormones such as insulin	The change in circulating hormones in peripheral blood	Before and 12 week after the start of the intervention
Circulating metabolites such as glucose	The change in metabolites in peripheral blood	Before and 12 week after the start of the intervention
Circulating inflammatory markers such as TNF	The change in inflammatory markers in peripheral blood	Before and 12 week after the start of the intervention
body weight	The change in body weight in kg	Before and 12 week after the start of the intervention
body composition	The change in body compostion as assessed using DEXA scans	Before and 12 week after the start of the intervention
liver fat content	The change in liver fat content as assessed by proton magnetic resonance spectrometry	Before and 12 week after the start of the intervention

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: NL72483.068.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No