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

University of Guadalajara

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: vitamin K diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06250647

20-18 (Other Identifier)

CI-04720

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

VK INTERVENTION

Experimental group

Description:

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

Treatment:

Other: vitamin K diet

DIETARY RECOMMENDATIONS

No Intervention group

Description:

No menu administration but only recommendations for correct diet.