Insulin resistance obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Abdominal obesity: waist circumference for men should be * 102 cm, and for women * 88 cm. - Caucasian - Aged 18 years and older - BMI * 25 kg/m2
Exclusion criteria
Exclusion criteria: - Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbAc1 > 6.5%). - Active of history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias, or sudden cardiac death). - Hyperlipidaemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L). - Lipid lowering medication (e.g. statins). - Use of medication known to influence glucose metabolism, vascular function, and/or lipid metabolism (e.g. statins, glucocorticosteroids, NSAID*s). - Inability to stop anti-hypertensive medication for 8 weeks. Exclusion of higher grade hypertension (> 179 mmHG SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks). - Pulmonary or inflammatory disease - Kidney failure or electrolyte disorder - Pregnancy or lactation - No change in use of oral anticonceptives or IUD (12 weeks before the intervention). - Unstable body weight (weight gain or loss > 3 kg in the last 2 months). - Known allergic reaction to ultrasound contrast-agent - Smoking (active or cessation 4 U/day) or drug abuse - Use of dietary supplements or an investigation product within the previous month - Significant food allergies/intolerance - Vegetarianism - Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention. - Participation in another biomedical trial during the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to investigate the effect of dietary AGE restriction on whole-body insulin sensitivity measured by the hyperinsulinemic-euglycemic clamp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, we aim to investigate the effects of restriction of dietary AGEs on cardio-metabolic health, biomarkers of AGEs, inflammation, and the gut microbiota. We will investigate the following parameters: - Micro- and macrovascular function by means of skeletal muscle contrast-enhanced ultrasound (CEUS) measurements, skin capillary videomicroscopy, skin laser Doppler flowmetry, arterial flow mediated dilation (FMD), and arterial stiffness (pulse wave velocity and local stiffness). - AGE measurements in blood plasma and skin. The latter by means of skin autofluorescence (SAF). - Glucose metabolism and *-cell function during two consecutive 30-min hyperglycaemic steps. - Markers of endothelial function, inflammation, and adipokine markers in blood plasma - Gut microbiota using 16s rRNA sequencing | — |
Countries
Netherlands