Obesity Clinical Trial
Official title:
Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.
Participants will be randomly assigned in one of two groups. Group A: oral supplementation
with 4,000 IU of vitamin D (cholecalciferol). Group B: oral supplementation with 400 IU of
vitamin D (cholecalciferol). Both treatments will be consumed daily for 6 months.
Outcomes will be evaluated at baseline, three and six months. Variables related to leptin
resistance will be evaluated.
The main hypothesis is that vitamin D will diminish leptin resistance in overweight and
obese women. If the hypothesis is confirmed, women will show a reduction in the Resting
energy expenditure: serum Leptin ratio (REE: Leptin ratio), as well as a reduction of
hunger, body weight, body and abdominal fat and an increase in resting energy expenditure.
Study subjects will get dietary advice and physical activity counseling. At the end of the
study, participants with suboptimal vitamin D levels (<80 nmol/L 25-OH-D) will receive
treatment to normalize their vitamin D status.
Variables related to leptin resistance like resting metabolic expenditure, hunger, body
weight and human body fat will be assessed. Outcomes will include, glucose, insulin,
C-reactive protein, inflammatory interleukins (IL-6 & TNF-α) and non-inflammatory
interleukins (IL-10 & TGF-β-1).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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