Vitamin D3 in Obesity: Identification of Central Nervous System Targets Using High-Technology Functional MRI

Recruiting

Conditions: Obesity

Registration Number: NL-OMON26821

Lead Sponsor: Investigator initiated trial

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
?Age between 18 – 35 years;
?Capability to provide informed consent;
?Stable weight (<5% change) for 3 months prior to study assessment.

Additionally, for the obese subset:
?BMI between 30 – 40 kg/m2;
?Metabolically unhealthy, defined as fasting plasma insulin levels >74 pmol/l at screening (89).

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study: ?
?Any medical disorder (with the exception of metabolic syndrome and other obesity-related disorders in the obese subset);
?Childhood-onset obesity;
?Contraindication to MRI scanning (e.g. claustrophobia, pacemaker, metal IUD);
?Participants who skip their breakfast or work in shifts;
?Serum 25-hydroxyvitamin D (25(OH)D) concentrations below 50 nmol L-1;
?Significant sensory or motor impairment;
?Subjects taking any medication except for medication for obesity-related metabolic disorders (excluding diabetes treatment)
?Subjects who cannot adhere to the experimental protocol for any reason;
?The use of weight loss agents or use within 3 months prior to study;
?Weight loss surgery or gastrectomy.
?Hypercalciemia at screening

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effects of calcitriol on neuronal activity in brain areas involved in food intake using functional magnetic resonance imaging (fMRI) in lean and obese subjects.

Secondary Outcome Measures

Name	Time	Method
The differences in calcitriol-induced dopaminergic effects between lean and obese participants and the effects of calcitriol on satiety, energy metabolism, and food-related behavior (questionnaires) in association with changes in fMRI responses.