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

NCT ID: NCT06250647

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-06
• Study Completion Date: 2021-08-16

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VK INTERVENTION

administration of a menu diet containing 500mcg of vitamin K (in the food selected) durinf 6 weeks.

Group Type: EXPERIMENTAL

vitamin K diet

Intervention Type: OTHER

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

DIETARY RECOMMENDATIONS

No menu administration but only recommendations for correct diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

vitamin K diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iris M Llamas-Covarrubias, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

PMID: 31119401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31947821 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29978853 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28356433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18614743 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31761961 (View on PubMed)

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):272-282. doi: 10.21149/8803. Spanish.

Reference Type: RESULT

PMID: 29746744 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-18

Identifier Type: OTHER

Identifier Source: secondary_id

CI-04720

Identifier Type: -

Identifier Source: org_study_id