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

February 6, 2024 updated by: University of Guadalajara

Effect of Dietary Intervention With a High Intake of Vitamin K on Insulin, Osteocalcin, Leptin, Vitamin K Serum Levels and Cardiovascular Risk in Young Adults With and Without Overweight or Obesity.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Centro Universitario de Ciencias de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VK INTERVENTION
administration of a menu diet containing 500mcg of vitamin K (in the food selected) durinf 6 weeks.
Other: vitamin K diet
500mcg of Vitamin K intake provided by the selection of vitamin k rich foods in the menu.
No Intervention: DIETARY RECOMMENDATIONS
No menu administration but only recommendations for correct diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitamin K serum levels
Time Frame: basal and after 6 weeks of diet intervention
ng/mL
basal and after 6 weeks of diet intervention
Cardiovascular Risk Percentage
Time Frame: basal and after 6 weeks of diet intervention
percentage (%)
basal and after 6 weeks of diet intervention
insulin serum levels
Time Frame: basal and after 6 weeks of diet intervention
mcUI/L
basal and after 6 weeks of diet intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteocalcin
Time Frame: basal and after 6 weeks of diet intervention
ng/mL
basal and after 6 weeks of diet intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: Iris M Llamas-Covarrubias, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2021

Primary Completion (Actual)

July 12, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-04720
  • 20-18 (Other Identifier: Universidad de Guadalajara)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie results in a publication

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

IPD will be shared by email request after the request review by the main researcher

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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