Personalized Fiber and Insulin Sensitivity

Personalized Microbial Substrates to Prevent Type 2 Diabetes

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:

1. 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;
2. 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

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance; Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Fermentable oligosaccharide; Dietary supplement: Personalized fiber mixture

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 5229ER
      • Recruiting
      • Maastricht University
      • Contact: Emanuel Canfora, PhD; Phone Number: +31-43 38 81669; Email: emanuel.canfora@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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
Active Comparator: isocaloric fermentable oligosaccaride	Dietary supplement: Fermentable oligosaccharide; Supplementation period 12 weeks
Experimental: Personalized fiber mixture; 12 g for 2 weeks, followed by 24 g for 10 weeks	Dietary supplement: Personalized fiber mixture; 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 (m-value) 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
circulating SCFA	The change in concentrations of circulating SCFA	Before and 12 week after the start of the intervention
Faecal SCFA	The change in concentrations of faecal 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 assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene	Before and 12 week after the start of the intervention
Circulating hormones such as insulin	The change in concentrations of circulating hormones in peripheral blood	Before and 12 week after the start of the intervention
Circulating metabolites such as glucose	The change in concentrations of metabolites in peripheral blood	Before and 12 week after the start of the intervention
body fat percentage	The change in body fat percentage as assessed using DEXA scans	Before and 12 week after the start of the intervention
fat mass	The change in fat mass in kg as assessed using DEXA scans	Before and 12 week after the start of the intervention
lean mass	The change in lean mass in kg as assessed using DEXA scans	Before and 12 week after the start of the intervention
visceral fat	The change in visceral fat in gram as assessed using DEXA scans	Before and 12 week after the start of the intervention
body weight	The change in body weight in kg using a weight scale	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): November 5, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: NL76905.068.21

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