Obesity, Overweight
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTCholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Sponsors
Mexican National Institute of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI: 25-29.9 * Serum vitamin D levels: 20-80 nmol/L (25-OH-D)
Exclusion criteria
* Liver disease * Kidney disease * Diabetes mellitus * Malignity * Any kind of hormonal disorder * Medication that modify hunger/satiety answer and those medications that alter -the glucose/insulin metabolism * Subjects with diet treatment to lose weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of leptin resistance: (resting energy expenditure: leptin ratio) before and after (3 and 6 months) supplementation with vitamin D3 (cholecalciferol) 4,000 or 400 IU/day. | basal, third and sixth month |
Secondary
| Measure | Time frame |
|---|---|
| Effect of vitamin D supplementation (25-OH-D): hunger, body weight, energy intake, resting energy expenditure, and body fat, improvement on low intensity chronic inflammation, SOCS-3 expression and JAK2/STAT3 signal. | Basal, third and sixth month |
Countries
Mexico
Contacts
Primary ContactMario Flores-Aldana, MsC
Backup ContactNayeli Macías-Morales, MsC
Outcome results
None listed