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OpenTrials
Completed

NCT Number: NCT06250647

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

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.

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Key information

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, 44340, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin K diet

Other

500mcg of Vitamin K intake provided by the selection of vitamin k rich foods in the menu.

Primary outcomes

  1. vitamin K serum levels

    Time frame: basal and after 6 weeks of diet intervention

    ng/mL

  2. Cardiovascular Risk Percentage

    Time frame: basal and after 6 weeks of diet intervention

    percentage (%)

  3. insulin serum levels

    Time frame: basal and after 6 weeks of diet intervention

    mcUI/L

Secondary outcomes

  1. Osteocalcin

    Time frame: basal and after 6 weeks of diet intervention

    ng/mL

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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.

Acronym: VKDI

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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