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

Primary Purpose

Overweight and Obesity, Cardiometabolic Risk Factors

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Vitamin K2
Cornstarch
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Vitamin K, Overweight and Obesity, Cardiometabolic Risk Factors

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University of Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplementation arm

Placebo arm

Arm Description

Vitamin K2

Cornstarch

Outcomes

Primary Outcome Measures

Osteocalcin serum concentration
ng/dL
Vitamin K serum concentration
ng/dL
Leptin serum concentration
ng/dL
Tumour Necrosis Factor alpha serum concentration
pg/mL
Interleukin-1 Beta serum concentration
pg/mL
Interleukin-6 serum concentration
pg/mL
Interleukin-4 serum concentration
pg/mL
Interleukin-10 serum concentration
pg/mL
Cardiovascular risk
percentage
LEP gene methylation
Methylated or unmethylated

Secondary Outcome Measures

Growth arrest-specific 6 protein serum concentration
ng/ml
Global methylation
percentage
Atherogenic indices
Value
Triglycerides serum concentration
mg/dL
Total cholesterol serum concentration
mg/dL
HDL cholesterol serum concentration
mg/dL
LDL cholesterol serum concentration
mg/dL
VLDL cholesterol serum concentration
mg/dL
Glucose serum concentration
mg/dL
Blood pressure
mmHg
Insulin serum concentration
µIU/ml
Weight
kg
Body mass index
kg/m2
Waist circumference
cm
Hip circumference
cm
Fat mass
kg
% fat
percentage
Lean mass
kg
Estimated energy consumption
kcal/day
Estimated protein consumption
grams/day
Estimated carbohydrates consumption
grams/day
Estimated fat consumption
grams/day
Estimated vitamin K consumption
μg/day

Full Information

First Posted
August 8, 2023
Last Updated
August 8, 2023
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT05995522
Brief Title
Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity
Official Title
Effect of Vitamin K2 Supplementation and Its Association With Osteocalcin Serum Levels, Leptin, Th1/Th2 Cytokine Profile, and Cardiovascular Risk in Young Mexican Adults With Overweight and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study Overview To meet the objectives of the project, two groups will be compared, one that will be supplemented with vitamin K and another of patients who will receive corn starch as a placebo. Patients are going to have a follow up during 3 months with periodic evaluations every 30 days. This is a double-blind study, it is achieved by maintaining similarities in appearance, taste and smell between the treatments that will be delivered in the same vials, with same number of pills and identical in shape, color and consistency for each study group. Patient recruitment will take place by disseminating information through physical and social media, once potential participants have been identified, they will be contacted and informed about the project, and if they decide to participate in the study, they will be asked to sign the informed consent. Simple randomization will be performed using R software to assign participants to one of the study groups. A clinical history, anthropometric measurements and blood sampling shall be applied. Nutritional recommendations based on the position of the Academy of Nutrition and Dietetics for the treatment of overweight and obesity and the healthy eating plate of Harvard University will be given. An appointment is to be scheduled every 30 days in order to provide the supplementation and follow-up. At the end, the pertinent statistical analyzes will be carried out. Notification of adverse effects will be made in each of the sessions, in addition to this the participants will have the contact of the researchers to notify any anomaly. Sample's size calculation The sample size was calculated using the statistical formula for the comparison of two means. This estimate was made using the following formula: n=2(Zα+Z[1-β]2xSD2/d2 Where: n= sample size required in each group SD= standard deviation of the effect Zα: to the value of Z for a confidence level of 95% Z[1-β}: to the value of Z for a statistical power of 80% D= effect size A total of 19.72 patients per group were obtained. Considering a 20% loss, 24 patients are needed per study group. Ethical considerations The study was approved by the Biosafety committee, research ethics committee and research committee of the University Center for Health Sciences, University of Guadalajara: CI-00421. The committees of the University have the authority to monitor and audit the study at any of its stages once it has been approved. Objetives General objective Evaluate the effect of vitamin K2 supplementation on methylation, the serum concentration of total vitamin K, osteocalcin, growth arrest-specific 6 protein, leptin, inflammatory markers, cardiometabolic risk factors and cardiovascular risk in young Mexican adults with overweight or obesity. Specific objectives Compare the baseline variables between groups. Compare the variable changes across the time within groups Compare the variable changes across the time between groups Statistical analysis The Shapiro-Wilk normality test is performed to determine whether the analysis will require parametric or non-parametric tests. Qualitative variables will be expressed as frequencies and percentages, while quantitative variables will be expressed as mean and standard deviation in parametric data or medians and ranges in non-parametric data. Specific objective 1 Statistical technique T-student for independent samples if it has a normal distribution or by U-Mann Whitney for independent samples if it does not have a normal distribution Specific objective 2 Variables with two measures Statistical technique T-student for paired samples if it has a normal distribution or the Wilcoxon signed-rank test if it does not have a normal distribution Variables with more than two measures Statistical technique Repeated measures ANOVA if it has a normal distribution or the Friedman Test if it does not have a normal distribution Specific objective 3 Statistical technique The effect size of the groups is compared with T-student for independent samples if it has a normal distribution or by U-Mann Whitney for independent samples if it does not have a normal distribution

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Cardiometabolic Risk Factors
Keywords
Vitamin K, Overweight and Obesity, Cardiometabolic Risk Factors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial parallel design. Two groups with intervention, one with supplementation and other with placebo
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplementation arm
Arm Type
Experimental
Arm Description
Vitamin K2
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Cornstarch
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2
Other Intervention Name(s)
Nutricost Menaquinone-4 100 µg
Intervention Description
100 µg per day for 90 days
Intervention Type
Other
Intervention Name(s)
Cornstarch
Intervention Description
500 mg per day for 90 days
Primary Outcome Measure Information:
Title
Osteocalcin serum concentration
Description
ng/dL
Time Frame
Baseline and after 90 days of intervention
Title
Vitamin K serum concentration
Description
ng/dL
Time Frame
Baseline and after 90 days of intervention
Title
Leptin serum concentration
Description
ng/dL
Time Frame
Baseline and after 90 days of intervention
Title
Tumour Necrosis Factor alpha serum concentration
Description
pg/mL
Time Frame
Baseline and after 90 days of intervention
Title
Interleukin-1 Beta serum concentration
Description
pg/mL
Time Frame
Baseline and after 90 days of intervention
Title
Interleukin-6 serum concentration
Description
pg/mL
Time Frame
Baseline and after 90 days of intervention
Title
Interleukin-4 serum concentration
Description
pg/mL
Time Frame
Baseline and after 90 days of intervention
Title
Interleukin-10 serum concentration
Description
pg/mL
Time Frame
Baseline and after 90 days of intervention
Title
Cardiovascular risk
Description
percentage
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
LEP gene methylation
Description
Methylated or unmethylated
Time Frame
Baseline and after 90 days of intervention
Secondary Outcome Measure Information:
Title
Growth arrest-specific 6 protein serum concentration
Description
ng/ml
Time Frame
Baseline and after 90 days of intervention
Title
Global methylation
Description
percentage
Time Frame
Baseline and after 90 days of intervention
Title
Atherogenic indices
Description
Value
Time Frame
Baseline and after 90 days of intervention
Title
Triglycerides serum concentration
Description
mg/dL
Time Frame
Baseline and after 90 days of intervention
Title
Total cholesterol serum concentration
Description
mg/dL
Time Frame
Baseline and after 90 days of intervention
Title
HDL cholesterol serum concentration
Description
mg/dL
Time Frame
Baseline and after 90 days of intervention
Title
LDL cholesterol serum concentration
Description
mg/dL
Time Frame
Baseline and after 90 days of intervention
Title
VLDL cholesterol serum concentration
Description
mg/dL
Time Frame
Baseline and after 90 days of intervention
Title
Glucose serum concentration
Description
mg/dL
Time Frame
Baseline and after 90 days of intervention
Title
Blood pressure
Description
mmHg
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Insulin serum concentration
Description
µIU/ml
Time Frame
Baseline and after 90 days of intervention
Title
Weight
Description
kg
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Body mass index
Description
kg/m2
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Waist circumference
Description
cm
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Hip circumference
Description
cm
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Fat mass
Description
kg
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
% fat
Description
percentage
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Lean mass
Description
kg
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Estimated energy consumption
Description
kcal/day
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Estimated protein consumption
Description
grams/day
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Estimated carbohydrates consumption
Description
grams/day
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Estimated fat consumption
Description
grams/day
Time Frame
Baseline, after 30, 60 and 90 days of intervention
Title
Estimated vitamin K consumption
Description
μg/day
Time Frame
Baseline, after 30, 60 and 90 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrés López Quintero, PhD
Phone
33 1058 5200
Ext
34294
Email
andres.lopezq@academicos.udg.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Edgar A Rivera León, PhD
Phone
(378) 782 8033
Ext
56928
Email
edgar.rleon@academicos.udg.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés López Quintero, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés López Quintero, PhD
Phone
33 1058 5200
Ext
34294
Email
andres.lopezq@academicos.udg.mx
First Name & Middle Initial & Last Name & Degree
Edgar A Rivera León, PhD
Phone
(378) 782 8033
Ext
56928
Email
edgar.rleon@academicos.udg.mx
First Name & Middle Initial & Last Name & Degree
Andrés López Quintero, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32831908
Citation
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.
Results Reference
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Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity

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