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

Overweight and Obesity Clinical Trial

— VKDI  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06250647
• Other study ID #: CI-04720
• Secondary ID: 20-18
• Status: Completed
• Phase: N/A
• Start date: February 6, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: February 2024
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 16, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
Mexico	Centro Universitario de Ciencias de la Salud	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Al-Suhaimi EA, Al-Jafary MA. Endocrine roles of vitamin K-dependent- osteocalcin in the relation between bone metabolism and metabolic disorders. Rev Endocr Metab Disord. 2020 Mar;21(1):117-125. doi: 10.1007/s11154-019-09517-9. — View Citation

Chen HG, Sheng LT, Zhang YB, Cao AL, Lai YW, Kunutsor SK, Jiang L, Pan A. Association of vitamin K with cardiovascular events and all-cause mortality: a systematic review and meta-analysis. Eur J Nutr. 2019 Sep;58(6):2191-2205. doi: 10.1007/s00394-019-01998-3. Epub 2019 May 22. — View Citation

Gaona-Pineda EB, Martinez-Tapia B, Arango-Angarita A, Valenzuela-Bravo D, Gomez-Acosta LM, Shamah-Levy T, Rodriguez-Ramirez S. [Food groups consumption and sociodemographic characteristics in Mexican population]. Salud Publica Mex. 2018 May-Jun;60(3):272- — View Citation

Shea MK, Booth SL, Weiner DE, Brinkley TE, Kanaya AM, Murphy RA, Simonsick EM, Wassel CL, Vermeer C, Kritchevsky SB; Health ABC Study. Circulating Vitamin K Is Inversely Associated with Incident Cardiovascular Disease Risk among Those Treated for Hypertension in the Health, Aging, and Body Composition Study (Health ABC). J Nutr. 2017 May;147(5):888-895. doi: 10.3945/jn.117.249375. Epub 2017 Mar 29. — View Citation

Simes DC, Viegas CSB, Araujo N, Marreiros C. Vitamin K as a Diet Supplement with Impact in Human Health: Current Evidence in Age-Related Diseases. Nutrients. 2020 Jan 3;12(1):138. doi: 10.3390/nu12010138. — View Citation

Vera-Remartinez EJ, Lazaro Monge R, Granero Chinesta S, Sanchez-Alcon Rodriguez D, Planelles Ramos MV. [Cardiovascular risk factors in young adults of a penitentiary center]. Rev Esp Salud Publica. 2018 Jul 6;92:e201807037. Spanish. — View Citation

Yoshida M, Booth SL, Meigs JB, Saltzman E, Jacques PF. Phylloquinone intake, insulin sensitivity, and glycemic status in men and women. Am J Clin Nutr. 2008 Jul;88(1):210-5. doi: 10.1093/ajcn/88.1.210. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin K serum levels	ng/mL	basal and after 6 weeks of diet intervention
Primary	Cardiovascular Risk Percentage	percentage (%)	basal and after 6 weeks of diet intervention
Primary	insulin serum levels	mcUI/L	basal and after 6 weeks of diet intervention
Secondary	Osteocalcin	ng/mL	basal and after 6 weeks of diet intervention