Restriction of dietary AGEs to prevent diabetes in overweight individuals: a randomized controlled trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 137

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

- 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 <1 year prior to screening date).
- High alcohol usage (>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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to investigate the effect of dietary AGE<br /><br>restriction on whole-body insulin sensitivity measured by the<br /><br>hyperinsulinemic-euglycemic clamp.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additionally, we aim to investigate the effects of restriction of dietary AGEs<br /><br>on cardio-metabolic health, biomarkers of AGEs, inflammation, and the gut<br /><br>microbiota. We will investigate the following parameters:<br /><br>- Micro- and macrovascular function by means of skeletal muscle<br /><br>contrast-enhanced ultrasound (CEUS) measurements, skin capillary<br /><br>videomicroscopy, skin laser Doppler flowmetry, arterial flow mediated dilation<br /><br>(FMD), and arterial stiffness (pulse wave velocity and local stiffness).<br /><br>- AGE measurements in blood plasma and skin. The latter by means of skin<br /><br>autofluorescence (SAF).<br /><br>- Glucose metabolism and *-cell function during two consecutive 30-min<br /><br>hyperglycaemic steps.<br /><br>- Markers of endothelial function, inflammation, and adipokine markers in blood<br /><br>plasma<br /><br>- Gut microbiota using 16s rRNA sequencing</p><br>