Insulin Resistance, Obesity
Conditions
Brief summary
Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity. The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.
Interventions
DIETARY_SUPPLEMENTPlacebo
Supplementation period 12 weeks
DIETARY_SUPPLEMENTWhole fiber product
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
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 \< 35 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. * Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body) * The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck * Claustrophobia
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 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 |
| Faecal and circulating SCFA | Before and 12 week after the start of the intervention | The change in faecal and circulating 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 as assessed via 16s rRNA gene sequencing |
| In vitro microbial activity testing | Before and 12 week after the start of the intervention | The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon |
| hepatic and adipose tissue insulin sensitivity | Before and 12 week after the start of the intervention | The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp |
| Circulating metabolites such as glucose | Before and 12 week after the start of the intervention | The change in metabolites in peripheral blood |
| Circulating inflammatory markers such as TNF | Before and 12 week after the start of the intervention | The change in inflammatory markers in peripheral blood |
| body weight | Before and 12 week after the start of the intervention | The change in body weight in kg |
| body composition | Before and 12 week after the start of the intervention | The change in body compostion as assessed using DEXA scans |
| liver fat content | Before and 12 week after the start of the intervention | The change in liver fat content as assessed by proton magnetic resonance spectrometry |
| Circulating hormones such as insulin | Before and 12 week after the start of the intervention | The change in circulating hormones in peripheral blood |
Countries
Netherlands
Outcome results
None listed