Personalized Fiber and Insulin Sensitivity

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Insulin Resistance
• Interventions: Dietary Supplement: Fermentable oligosaccharide; Dietary Supplement: Personalized fiber mixture

• Registration Number: NCT05378295
• Lead Sponsor: Maastricht University Medical Center

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:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-05
• Status Verified: 2022-05
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isocaloric fermentable oligosaccaride	Fermentable oligosaccharide	isocaloric fermentable oligosaccaride
Personalized fiber mixture	Personalized fiber mixture	12 g for 2 weeks, followed by 24 g for 10 weeks

Primary Outcome Measures

Name	Time	Method
Peripheral insulin sensitivity	Before and 12 week after the start of the intervention	The change of peripheral insulin sensitivity (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp

Secondary Outcome Measures

Name	Time	Method
Substrate oxidation (indirect calorimetry)	Before and 12 week after the start of the intervention	The change in substrate oxidation as measured via ventilated hood system
circulating SCFA	Before and 12 week after the start of the intervention	The change in concentrations of circulating SCFA
Circulating hormones such as insulin	Before and 12 week after the start of the intervention	The change in concentrations of circulating hormones in peripheral blood
fat mass	Before and 12 week after the start of the intervention	The change in fat mass in kg as assessed using DEXA scans
Energy expenditure (indirect calorimetry)	Before and 12 week after the start of the intervention	The change in energy expenditure as measured via ventilated hood system
Circulating metabolites such as glucose	Before and 12 week after the start of the intervention	The change in concentrations of metabolites in peripheral blood
body weight	Before and 12 week after the start of the intervention	The change in body weight in kg using a weight scale
Faecal SCFA	Before and 12 week after the start of the intervention	The change in concentrations of faecal SCFA
Faecal microbiota composition and in vitro microbial activity testing	Before and 12 week after the start of the intervention	The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene
body fat percentage	Before and 12 week after the start of the intervention	The change in body fat percentage as assessed using DEXA scans
lean mass	Before and 12 week after the start of the intervention	The change in lean mass in kg as assessed using DEXA scans
visceral fat	Before and 12 week after the start of the intervention	The change in visceral fat in gram as assessed using DEXA scans

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands