High Vitamin K Intake Diet Intervention Effect on Cardiovascular Risk Percentage in Young Adults

Not Applicable

Completed

• Conditions: Overweight and Obesity

• Registration Number: NCT06250647
• Lead Sponsor: University of Guadalajara

Brief Summary

The goal of this clinical trial is to compare the effect of a high vitamin K diet intervention on vitamin K, insulin, osteocalcin serum levels and the cardiovascular risk percentage in normal weight and overweight or obese young adults. The main questions it aims to answer are: • Does a diet intervention containing 500mcg of vitamin K increases serum vitamin K levels? • Are vitamin K serum levels after the 500mcg of vitamin K diet intervention associated with insulin and osteocalcin serum levels or the cardiovascular risk percentage in normal weight and overweight or obese young adults? Participants will have to follow a diet intervention that contains 500mcg of vitamin K, given as a cyclic menu for 6 weeks. Also, participants will have to assist weekly to nutritional monitoring and to report any situation they observed regarding the intervention during this study. Researchers will compare normal weight and overweight or obese groups with diet intervention with normal weight and overweight or obese groups without diet intervention and only dietetic recommendations to see if vitamin K serum levels, insulin, osteocalcin and the cardiovascular risk percentage improve after the 6 weeks diet intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-06
• Primary Completion: 2021-07-12
• Study Completion: 2021-08-16
• Study First Submitted: 2023-11-27
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• young adults
• acceptation for participate
• acceptation to asist to monitoring sessions
• sign information consent

Exclusion Criteria

• under other dietetic intervention
• under medications that interfere with vitamin K or diminish its absorbtion
• vitamin E or A intake supplements
• previous diagnose of metabolic syndrome, diabetes mellitus, hypertension, cancer or dyslipidemia.
• chronic alcohol intake
• some medical or health situation that impedes the following of the program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
vitamin K serum levels	basal and after 6 weeks of diet intervention	ng/mL
Cardiovascular Risk Percentage	basal and after 6 weeks of diet intervention	percentage (%)
insulin serum levels	basal and after 6 weeks of diet intervention	mcUI/L

Secondary Outcome Measures

Name	Time	Method
Osteocalcin	basal and after 6 weeks of diet intervention	ng/mL

Trial Locations

Locations (1)

Centro Universitario de Ciencias de la Salud; 🇲🇽 Guadalajara, Jalisco, Mexico