Insulin Resistance, Type 2 Diabetes
Conditions
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
Interventions
DIETARY_SUPPLEMENTFermentable oligosaccharide
Supplementation period 12 weeks
DIETARY_SUPPLEMENTPersonalized fiber mixture
Supplementation period 12 weeks
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| fat mass | Before and 12 week after the start of the intervention | The change in fat mass in kg as assessed using DEXA scans |
| 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 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 |
| body weight | Before and 12 week after the start of the intervention | The change in body weight in kg using a weight scale |
| 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 |
Countries
Netherlands
Outcome results
None listed