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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26821
Enrollment
30
Registered
2019-02-20
Start date
2019-02-04
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Obesity

Interventions

This study consists of two interventions involving one calcitriol and one placebo (saline) infusion (order determined upon randomization).

Sponsors

Investigator initiated trial
Lead Sponsor

Eligibility

Inclusion criteria

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 (74 pmol/l at screening (89).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactSabrina Oussaada

Amsterdam UMC

s.m.oussaada@amsterdamumc.nl+31636166535

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)