Obesity Clinical Trial
Official title:
Effects of Vitamin D3 and Vitamin K2MK7 Supplementation on Vascular Function in Overweight or Obese Adults.
A prospective, randomized, placebo-controlled, double-blind study that aims to evaluate the effects of combined vitamin D3 and K2-MK7 supplementation on vascular function, sympathetic tone, metabolic biomarkers and inflammatory factors in a population of overweight or obese adults and deficient or insufficient serum levels of vitamin D.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 15, 2023 |
Est. primary completion date | July 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: - Vitamin D deficiency; - Vitamin D insufficiency; - Obesity; - Overweight; Exclusion Criteria: - Diabetes mellitus; - Arterial coronary disease; - Beta blocker use; - cancer; - ESRD; |
Country | Name | City | State |
---|---|---|---|
Brazil | Rio de Janeiro State University | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Pedro Ernesto | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microvascular reactivity | A laser speckle contrast imaging system with a laser wavelength of 785 nm system will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release. | 150 minutes | |
Secondary | Central blood pressure | Central systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure before and after intervention and their potential effects on changes in subendocardial viability ratio and ejection duration after intervention with beetroot juice and water. | 150 minutes |
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