Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

The goal of this clinical trial is to compare de effect of vitamin K2 in young adults with overweight or obesity.

The main questions to answer are: What is the effect of Vitamin K2 supplementation on methylation, serum concentration of ucOC, cOC, Gas6, leptin, inflammatory markers, cardiometabolic risk factors, and cardiovascular risk in overweight or obese young adults?

It had two arms (groups): Supplementation arm (experimental) and Placebo arm (placebo comparator).

Vitamin K2.

Cornstarch.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Study Overview To meet the objectives of the project, two groups will be compared, one that will be supplemented with vitamin K and another of patients who will receive corn starch as a placebo.

Patients are going to have a follow up during 3 months with periodic evaluations every 30 days.

This is a double-blind study, it is achieved by maintaining similarities in appearance, taste and smell between the treatments that will be delivered in the same vials, with same number of pills and identical in shape, color and consistency for each study group.

Simple randomization will be performed using R software to assign participants to one of the study groups.

Who Took Part

51 actual participants took part.

It was open to people of any sex aged from 18 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Body Mass Index greater than 25 kg/m2 and less than 40 kg/m2. That they agree to participate in the study voluntarily and informed and sign the informed consent.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: people with self-reported diagnosis of chronic kidney, gastrointestinal or systemic disease; patients who are on a hypocaloric or low-fat diet; self-reported pregnancy.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Those kept unaware of assignments: participant and investigator.

It started in 2023-09-01 with completion listed for 2023-11-30.

It ran at 1 site in Mexico.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Osteocalcin serum concentration (time frame: Baseline and after 90 days of intervention). Vitamin K serum concentration (time frame: Baseline and after 90 days of intervention). Leptin serum concentration (time frame: Baseline and after 90 days of intervention).

It also tracked 23 secondary outcomes, for example Growth arrest-specific 6 protein serum concentration, Global methylation, Atherogenic indices, Triglycerides serum concentration, Total cholesterol serum concentration and HDL cholesterol serum concentration.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 51 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.