Clinical trial NCT06250647: High Vitamin K Intake Diet Intervention Effect on Cardiovascular Risk Percentage in Young Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Vitamin K
diet intervention
Cardiovascular disease
overweight and obesity
young adults
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: vitamin K serum levels
timeFrame: basal and after 6 weeks of diet intervention
measure: Cardiovascular Risk Percentage
timeFrame: basal and after 6 weeks of diet intervention
measure: insulin serum levels
timeFrame: basal and after 6 weeks of diet intervention
Secondary outcomes:
measure: Osteocalcin
timeFrame: basal and after 6 weeks of diet intervention
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Universitario de Ciencias de la Salud
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Iris M Llamas-Covarrubias, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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):272-282. doi: 10.21149/8803. Spanish.