Overweight and ObesityNCT05995522
Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity
A study testing Vitamin K2 and Cornstarch in people with Overweight and Obesity and Cardiometabolic Risk Factors, run by University of Guadalajara at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Overweight and Obesity, Cardiometabolic Risk Factors
- What is being tested?
- Vitamin K2 and Cornstarch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Vitamin K2, Cornstarch
- Keywords
- Vitamin K, Overweight and Obesity, Cardiometabolic Risk Factors
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Dietary supplement
Also called Nutricost Menaquinone-4 100 µg
100 µg per day for 90 days
CornstarchOther
500 mg per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Supplementation arm | Experimental | Vitamin K2 Receives: Dietary Supplement: Vitamin K2 |
| Placebo arm | Placebo comparator | Cornstarch Receives: Other: Cornstarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin serum concentration
ng/dL
Measured: Baseline and after 90 days of intervention
Vitamin K serum concentration
ng/dL
Measured: Baseline and after 90 days of intervention
Leptin serum concentration
ng/dL
Measured: Baseline and after 90 days of intervention
Tumour Necrosis Factor alpha serum concentration
pg/mL
Measured: Baseline and after 90 days of intervention
Interleukin-1 Beta serum concentration
pg/mL
Measured: Baseline and after 90 days of intervention
Interleukin-6 serum concentration
pg/mL
Measured: Baseline and after 90 days of intervention
Interleukin-4 serum concentration
pg/mL
Measured: Baseline and after 90 days of intervention
Interleukin-10 serum concentration
pg/mL
Measured: Baseline and after 90 days of intervention
Cardiovascular risk
percentage
Measured: Baseline, after 30, 60 and 90 days of intervention
LEP gene methylation
Methylated or unmethylated
Measured: Baseline and after 90 days of intervention
Secondary outcomes (23)
Growth arrest-specific 6 protein serum concentration
ng/ml
Measured: Baseline and after 90 days of intervention
Global methylation
percentage
Measured: Baseline and after 90 days of intervention
Atherogenic indices
Value
Measured: Baseline and after 90 days of intervention
Triglycerides serum concentration
mg/dL
Measured: Baseline and after 90 days of intervention
Total cholesterol serum concentration
mg/dL
Measured: Baseline and after 90 days of intervention
HDL cholesterol serum concentration
mg/dL
Measured: Baseline and after 90 days of intervention
LDL cholesterol serum concentration
mg/dL
Measured: Baseline and after 90 days of intervention
VLDL cholesterol serum concentration
mg/dL
Measured: Baseline and after 90 days of intervention
Glucose serum concentration
mg/dL
Measured: Baseline and after 90 days of intervention
Blood pressure
mmHg
Measured: Baseline, after 30, 60 and 90 days of intervention
Insulin serum concentration
µIU/ml
Measured: Baseline and after 90 days of intervention
Weight
kg
Measured: Baseline, after 30, 60 and 90 days of intervention
Body mass index
kg/m2
Measured: Baseline, after 30, 60 and 90 days of intervention
Waist circumference
cm
Measured: Baseline, after 30, 60 and 90 days of intervention
Hip circumference
cm
Measured: Baseline, after 30, 60 and 90 days of intervention
Fat mass
kg
Measured: Baseline, after 30, 60 and 90 days of intervention
% fat
percentage
Measured: Baseline, after 30, 60 and 90 days of intervention
Lean mass
kg
Measured: Baseline, after 30, 60 and 90 days of intervention
Estimated energy consumption
kcal/day
Measured: Baseline, after 30, 60 and 90 days of intervention
Estimated protein consumption
grams/day
Measured: Baseline, after 30, 60 and 90 days of intervention
Estimated carbohydrates consumption
grams/day
Measured: Baseline, after 30, 60 and 90 days of intervention
Estimated fat consumption
grams/day
Measured: Baseline, after 30, 60 and 90 days of intervention
Estimated vitamin K consumption
μg/day
Measured: Baseline, after 30, 60 and 90 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial parallel design. Two groups with intervention, one with supplementation and other with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés López Quintero, University of Guadalajara
- Investigators
- Andrés López Quintero, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995522
- Sponsor's protocol ID
- CI-00421
- Status last verified
- May 2024
- First submitted
- 8 Aug 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32831908
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05995522
- Acronym / sponsor ID
- CI-00421
- Keywords
- Vitamin K, Overweight and Obesity, Cardiometabolic Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial parallel design. Two groups with intervention, one with supplementation and other with placebo
| Arm | Type | Receives |
|---|---|---|
| Supplementation arm | Experimental | Dietary Supplement: Vitamin K2Vitamin K2 |
| Placebo arm | Placebo comparator | Other: CornstarchCornstarch |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2Also: Nutricost Menaquinone-4 100 µg100 µg per day for 90 days | Dietary supplement | Supplementation arm |
| Cornstarch500 mg per day for 90 days | Other | Placebo arm |
Primary outcome
Osteocalcin serum concentration
Time frame: Baseline and after 90 days of intervention
ng/dL
Vitamin K serum concentration
Time frame: Baseline and after 90 days of intervention
ng/dL
Leptin serum concentration
Time frame: Baseline and after 90 days of intervention
ng/dL
Tumour Necrosis Factor alpha serum concentration
Time frame: Baseline and after 90 days of intervention
pg/mL
Interleukin-1 Beta serum concentration
Time frame: Baseline and after 90 days of intervention
pg/mL
Interleukin-6 serum concentration
Time frame: Baseline and after 90 days of intervention
pg/mL
Interleukin-4 serum concentration
Time frame: Baseline and after 90 days of intervention
pg/mL
Interleukin-10 serum concentration
Time frame: Baseline and after 90 days of intervention
pg/mL
Cardiovascular risk
Time frame: Baseline, after 30, 60 and 90 days of intervention
percentage
LEP gene methylation
Time frame: Baseline and after 90 days of intervention
Methylated or unmethylated
23 secondary outcomes
Growth arrest-specific 6 protein serum concentration
Time frame: Baseline and after 90 days of intervention
Global methylation
Time frame: Baseline and after 90 days of intervention
Atherogenic indices
Time frame: Baseline and after 90 days of intervention
Triglycerides serum concentration
Time frame: Baseline and after 90 days of intervention
Total cholesterol serum concentration
Time frame: Baseline and after 90 days of intervention
HDL cholesterol serum concentration
Time frame: Baseline and after 90 days of intervention
LDL cholesterol serum concentration
Time frame: Baseline and after 90 days of intervention
VLDL cholesterol serum concentration
Time frame: Baseline and after 90 days of intervention
Glucose serum concentration
Time frame: Baseline and after 90 days of intervention
Blood pressure
Time frame: Baseline, after 30, 60 and 90 days of intervention
Insulin serum concentration
Time frame: Baseline and after 90 days of intervention
Weight
Time frame: Baseline, after 30, 60 and 90 days of intervention
Body mass index
Time frame: Baseline, after 30, 60 and 90 days of intervention
Waist circumference
Time frame: Baseline, after 30, 60 and 90 days of intervention
Hip circumference
Time frame: Baseline, after 30, 60 and 90 days of intervention
Fat mass
Time frame: Baseline, after 30, 60 and 90 days of intervention
% fat
Time frame: Baseline, after 30, 60 and 90 days of intervention
Lean mass
Time frame: Baseline, after 30, 60 and 90 days of intervention
Estimated energy consumption
Time frame: Baseline, after 30, 60 and 90 days of intervention
Estimated protein consumption
Time frame: Baseline, after 30, 60 and 90 days of intervention
Estimated carbohydrates consumption
Time frame: Baseline, after 30, 60 and 90 days of intervention
Estimated fat consumption
Time frame: Baseline, after 30, 60 and 90 days of intervention
Estimated vitamin K consumption
Time frame: Baseline, after 30, 60 and 90 days of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 32831908Aguayo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrés López Quintero, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 and Cornstarch in people with Overweight and Obesity and Cardiometabolic Risk Factors, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteocalcin serum concentration (time frame: Baseline and after 90 days of intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.