NCT05995522Completed
Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity
Effect of Vitamin K2 Supplementation and Its Association With Osteocalcin Serum Levels, Leptin, Th1/Th2 Cytokine Profile, and Cardiovascular Risk in Young Mexican Adults With Overweight and Obesity
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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? Participants will be assigned to one of two intervention groups where they will consume Vitamin K2 100 µg per day or cornstarch 500 mg per day for 90 days. If there is a comparison group: Investigators will compare the supplementation group (Vitamin K2) with the placebo group (cornstarch) to see if vitamin K2 supplementation modifies methylation, increases serum vitamin K, osteocalcin, growth arrest-specific 6 protein serum concentration, decreases serum leptin concentration, inflammatory markers and reduces cardiometabolic risk factors and cardiovascular risk.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 8 Aug 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- University of Guadalajara
- Diseases
- Obesity
- NCT number
- NCT05995522
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 1 Sept 2023 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- People with self-reported diagnosis of chronic kidney, gastrointestinal or systemic disease
Lab values
- Use of bile acid sequestrants drugs, insulin, glucocorticoids, contraceptives, bisphosphonates, thiazides, levetiracetam, thiazolidinediones, anticoagulants or estrogenic drugs and vitamin D, vitamin K, vitamin A, vitamin E, omegas or calcium supplements
Other
- Patients who are on a hypocaloric or low-fat diet
- Self-reported pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 35 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.