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Gut-to-brain Signalling of Post-Ingestion Nutrients in lean and obese subjects

Recruiting
Conditions
obesity
Post-ingestion nutrient signals/effects
10003018
Registration Number
NL-OMON50660
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

Age: 50-70 years for female subjects and 40-70 years for male subjects, for
female subjects: postmenopausal, BMI <25 kg/m2 for lean subjects and >30 kg/m2
for obese subjects, insulin resistance for obese subjects, stable weight for 3
months prior to study inclusion

Exclusion Criteria

Use of any medication except for those related to treatment of components of
the metabolic syndrome (not including insulin, oral glucose lowering drugs,
alpha- and beta-blockers)
Any actual medical condition except for treated hypothyroidism and the
metabolic syndrome
History of any psychiatric disorder, neurological disorders, eating disorders
(anorexia, binge eating, bulimia), alcohol abuse or upper gastrointestinal
tract surgery/abnormalities.
Shift work
Intensive sports (>3/week)
Restrained eaters
Smoking
XTC, cannabis, amphetamine or cocaine abuse
Alcohol abuse (>3 units/day)
Occupational radiation exposure
Contraindication for MRI
Lactose/gluten intolerance
Soya oil, egg or peanut allergy
Childhood onset of obesity (<4 years)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The effect of intragastric infusion of nutrients on:<br /><br>- Brain activity assessed as the induced change in BOLD signal and resting<br /><br>state brain connectivity measured with fMRI.<br /><br>- Striatal dopamine response, measured as the change in D2/D3R binding<br /><br>potential of IBZM assessed by SPECT. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The effect of intragastric infusion of nutrients on:<br /><br>- Glucoregulatory and gut hormone release<br /><br>- Objective scores of hunger and satiety during a buffet test meal after the<br /><br>infusion of the nutrients.<br /><br>- Subjective (VAS) scores of hunger and satiety<br /><br>- Neuropsychological functioning and feeding behaviour characteristics assessed<br /><br>by questionnaires and tasks<br /><br>Assess the correlations between brain activity and weight loss maintenance one<br /><br>year after the diet intervention</p><br>
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