Clinical trial NCT05378295: Personalized Fiber and Insulin Sensitivity
Official title: Personalized Microbial Substrates to Prevent Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Insulin Resistance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral insulin sensitivity
timeFrame: Before and 12 week after the start of the intervention
Secondary outcomes:
measure: Energy expenditure (indirect calorimetry)
timeFrame: Before and 12 week after the start of the intervention
measure: Substrate oxidation (indirect calorimetry)
timeFrame: Before and 12 week after the start of the intervention
measure: circulating SCFA
timeFrame: Before and 12 week after the start of the intervention
measure: Faecal SCFA
timeFrame: Before and 12 week after the start of the intervention
measure: Faecal microbiota composition and in vitro microbial activity testing
timeFrame: Before and 12 week after the start of the intervention
measure: Circulating hormones such as insulin
timeFrame: Before and 12 week after the start of the intervention
measure: Circulating metabolites such as glucose
timeFrame: Before and 12 week after the start of the intervention
measure: body fat percentage
timeFrame: Before and 12 week after the start of the intervention
measure: fat mass
timeFrame: Before and 12 week after the start of the intervention
measure: lean mass
timeFrame: Before and 12 week after the start of the intervention
measure: visceral fat
timeFrame: Before and 12 week after the start of the intervention
measure: body weight
timeFrame: Before and 12 week after the start of the intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: