Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity

NCT05995522 | Completed

• 1 other identifier: CI-00421
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare de effect of vitamin K2 in young adults with overweight or obesity. The main questions to answer are: What is the effect of Vitamin K2 supplementation on methylation, serum concentration of ucOC, cOC, Gas6, leptin, inflammatory markers, cardiometabolic risk factors, and cardiovascular risk in overweight or obese young adults? Participants will be assigned to one of two intervention groups where they will consume Vitamin K2 100 µg per day or cornstarch 500 mg per day for 90 days. If there is a comparison group: Investigators will compare the supplementation group (Vitamin K2) with the placebo group (cornstarch) to see if vitamin K2 supplementation modifies methylation, increases serum vitamin K, osteocalcin, growth arrest-specific 6 protein serum concentration, decreases serum leptin concentration, inflammatory markers and reduces cardiometabolic risk factors and cardiovascular risk.

Conditions

Overweight and Obesity; Cardiometabolic Risk Factors

Keywords

Vitamin K; Overweight and Obesity; Cardiometabolic Risk Factors

Outcome Measures

Primary Outcomes (10)

• Osteocalcin serum concentration

  ng/dL

  Baseline and after 90 days of intervention

• Vitamin K serum concentration

  ng/dL

  Baseline and after 90 days of intervention

• Leptin serum concentration

  ng/dL

  Baseline and after 90 days of intervention

• Tumour Necrosis Factor alpha serum concentration

  pg/mL

  Baseline and after 90 days of intervention

• Interleukin-1 Beta serum concentration

  pg/mL

  Baseline and after 90 days of intervention

• Interleukin-6 serum concentration

  pg/mL

  Baseline and after 90 days of intervention

• Interleukin-4 serum concentration

  pg/mL

  Baseline and after 90 days of intervention

• Interleukin-10 serum concentration

  pg/mL

  Baseline and after 90 days of intervention

• Cardiovascular risk

  percentage

  Baseline, after 30, 60 and 90 days of intervention

• LEP gene methylation

  Methylated or unmethylated

  Baseline and after 90 days of intervention

Secondary Outcomes (23)

• Growth arrest-specific 6 protein serum concentration

  Baseline and after 90 days of intervention

• Global methylation

  Baseline and after 90 days of intervention

• Atherogenic indices

  Baseline and after 90 days of intervention

• Triglycerides serum concentration

  Baseline and after 90 days of intervention

• Total cholesterol serum concentration

  Baseline and after 90 days of intervention

Study Arms (2)

Supplementation arm

EXPERIMENTAL

Vitamin K2

Dietary Supplement: Vitamin K2

Placebo arm

PLACEBO COMPARATOR

Cornstarch

Other: Cornstarch

Interventions

Vitamin K2 DIETARY_SUPPLEMENT

100 µg per day for 90 days

Also known as: Nutricost Menaquinone-4 100 µg

Supplementation arm

Cornstarch OTHER

500 mg per day for 90 days

Placebo arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index greater than 25 kg/m2 and less than 40 kg/m2
• That they agree to participate in the study voluntarily and informed and sign the informed consent

You may not qualify if:

• People with self-reported diagnosis of chronic kidney, gastrointestinal or systemic disease
• Use of bile acid sequestrants drugs, insulin, glucocorticoids, contraceptives, bisphosphonates, thiazides, levetiracetam, thiazolidinediones, anticoagulants or estrogenic drugs and vitamin D, vitamin K, vitamin A, vitamin E, omegas or calcium supplements
• Patients who are on a hypocaloric or low-fat diet
• Self-reported pregnancy

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (1)

• Aguayo-Ruiz JI, Garcia-Cobian TA, Pascoe-Gonzalez S, Sanchez-Enriquez S, Llamas-Covarrubias IM, Garcia-Iglesias T, Lopez-Quintero A, Llamas-Covarrubias MA, Trujillo-Quiroz J, Rivera-Leon EA. Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double-blind, clinical trial. Diabetol Metab Syndr. 2020 Aug 18;12:73. doi: 10.1186/s13098-020-00580-w. eCollection 2020.

  PMID: 32831908 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Vitamin K 2; Starch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Andrés López Quintero, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All participants were given an identical vial, with an invention similar in shape, color, and consistency. The groups were named group A and group B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor B

Model Details: Clinical trial parallel design. Two groups with intervention, one with supplementation and other with placebo

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: September 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)