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

NCT06250647 | Completed

• 2 other identifiers: CI-0472020-18
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Vitamin K; diet intervention; Cardiovascular disease; overweight and obesity; young adults

Outcome Measures

Primary Outcomes (3)

• vitamin K serum levels

  ng/mL

  basal and after 6 weeks of diet intervention

• Cardiovascular Risk Percentage

  percentage (%)

  basal and after 6 weeks of diet intervention

• insulin serum levels

  mcUI/L

  basal and after 6 weeks of diet intervention

Secondary Outcomes (1)

• Osteocalcin

  basal and after 6 weeks of diet intervention

Study Arms (2)

VK INTERVENTION

EXPERIMENTAL

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

Other: vitamin K diet

DIETARY RECOMMENDATIONS

NO INTERVENTION

No menu administration but only recommendations for correct diet.

Interventions

vitamin K diet OTHER

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

VK INTERVENTION

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (7)

• 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.

  PMID: 31119401 BACKGROUND

• 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.

  PMID: 31947821 BACKGROUND

• 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.

  PMID: 29978853 BACKGROUND

• 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.

  PMID: 28356433 BACKGROUND

• 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.

  PMID: 18614743 BACKGROUND

• 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.

  PMID: 31761961 BACKGROUND

• 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.

  PMID: 29746744 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris M Llamas-Covarrubias, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: February 9, 2024
• Study Start: February 6, 2021
• Primary Completion: July 12, 2021
• Study Completion: August 16, 2021
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication
• Access Criteria: IPD will be shared by email request after the request review by the main researcher

Locations

ME (1)