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

Restriction of dietary AGEs to prevent diabetes in overweight individuals: a randomized controlled trial - de-AGE-ing study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48992
Enrollment
137
Registered
2018-01-31
Start date
2018-09-25
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin resistance obesity

Interventions

All subjects will undergo an intervention consisting of a prescribed diet during 4 continuous weeks. Subjects will follow either a low AGE-diet or a habitual Dutch diet. Both diets will be similar i

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)