Personalized Fiber and Insulin Sensitivity

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Insulin Resistance; Type 2 Diabetes

Treatments: Dietary Supplement: Personalized fiber mixture; Dietary Supplement: Fermentable oligosaccharide

Study type: Interventional

Funder types: Other

Identifiers

NCT05378295

NL76905.068.21

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

isocaloric fermentable oligosaccaride

Active Comparator group

Description:

isocaloric fermentable oligosaccaride

Treatment:

Dietary Supplement: Fermentable oligosaccharide

Personalized fiber mixture

Experimental group

Description:

12 g for 2 weeks, followed by 24 g for 10 weeks

Treatment:

Dietary Supplement: Personalized fiber mixture