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The effect of a combined caloric restriction and exercise intervention on phenotypic profiles of offspring of families with exceptional longevity and their partners

Recruiting
Conditions
lichaamsgewicht, lichaamssamenstelling, bloeddruk, metabole markers gerelateerd aan glucose- en vetstofwisseling
body composition
energy metabolism
fat metabolism
glucose metabolisme
Registration Number
NL-OMON41285
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
194
Inclusion Criteria

Main study:
• Middle-aged (<75years) couples consisting of offspring from long-lived siblings and his/her current partner. In incidental cases they can participate as singles.
• BMI >=23 and <=35 kg/m2;Validation study:
• Middle-aged persons (age >= 60 and <= 70).
• BMI >=23 and <=35 kg/m2
• Participants must bring their own bike

Exclusion Criteria

Main study:
• Type I or type II diabetes (on diabetic medication)
• Individuals who have lost or gained >=3 kg over the past 6 months
• Individuals engaged in heavy/intensive physical activity (top sport or physically heavy work)
• Any disease or condition that seriously affects body weight and/or body composition including active types of cancer, heart failure (NYHA III/VI), COPD (GOLD III/VI)
• Recent (3 months prior to intervention) immobilisation for longer than 1 week
• Psychiatric or behavioral problems (eg, history or clinical manifestation of any eating disorders, vegan dietary lifestyle, major depression)
• Medication: thyroid medication, immunosuppressive drugs (e.g. prednisone, methotrexat, biologicals (TNF-alpha antagonists etc))
use of anticoagulantia (e.g. coumarines, carbaspirin calcium): only excluded for biopsies
• Concurrent participation in any other intervention study or weight management program;Magnetic Resonance (MR) exclusion criteria (3 tesla and 7 tesla):
• Claustrophobia
• Pacemakers and defibrillators
• Nerve stimulators
• Intracranial clips
• Intraorbital or intraocular metallic fragments
• Cochlear implants
• Ferromagnetic implants (e.g. thoracic implant for scoliosis)
• Inability to lie supine during for 1 hour
• not having a general practitioner;Validation study:
• Any conditions that may inhibit free movement
• Individuals engaged in heavy/intensive physical activity (top sport or physically heavy work)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary outcome measure is the change in fasting insulin level. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome measures are blood parameters (metabolic/metabolomics),<br /><br>parameters measured in biopsies of muscle and fat (proteomics/epigenetics),<br /><br>anthropometrics, body composition, blood pressure, 24-hour glucose monitoring,<br /><br>glucose load, energy metabolism (resting metabolic rate), and psychological<br /><br>factors (cognitive performance, mood, quality of life, sleep, hunger)<br /><br>parameters Magnetic Resonance (MR) scan (leg, brain, knee cartilage) and<br /><br>activity levels.</p><br>
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