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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Guadalajara
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Interleukin-4 serum concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
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.
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Interleukin-4 serum concentration
Time Frame: Baseline and after 90 days of intervention
pg/mL
LEP gene methylation
Time Frame: Baseline and after 90 days of intervention
Methylated or unmethylated
Interleukin-1 Beta 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
Osteocalcin 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-6 serum concentration
Time Frame: Baseline and after 90 days of intervention
pg/mL
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
Secondary Outcomes
- Blood pressure(Baseline, after 30, 60 and 90 days of intervention)
- Estimated carbohydrates consumption(Baseline, after 30, 60 and 90 days of intervention)
- VLDL cholesterol serum concentration(Baseline and after 90 days of intervention)
- Atherogenic indices(Baseline and after 90 days of intervention)
- HDL cholesterol serum concentration(Baseline and after 90 days of intervention)
- LDL cholesterol serum concentration(Baseline and after 90 days of intervention)
- Hip circumference(Baseline, after 30, 60 and 90 days of intervention)
- Estimated energy consumption(Baseline, after 30, 60 and 90 days of intervention)
- Estimated vitamin K consumption(Baseline, after 30, 60 and 90 days of intervention)
- Global methylation(Baseline and after 90 days of intervention)
- Triglycerides serum concentration(Baseline and after 90 days of intervention)
- Weight(Baseline, after 30, 60 and 90 days of intervention)
- Lean mass(Baseline, after 30, 60 and 90 days of intervention)
- Estimated fat consumption(Baseline, after 30, 60 and 90 days of intervention)
- Growth arrest-specific 6 protein serum concentration(Baseline and after 90 days of intervention)
- Glucose serum concentration(Baseline and after 90 days of intervention)
- Insulin serum concentration(Baseline and after 90 days of intervention)
- Waist circumference(Baseline, after 30, 60 and 90 days of intervention)
- Fat mass(Baseline, after 30, 60 and 90 days of intervention)
- Total cholesterol serum concentration(Baseline and after 90 days of intervention)
- Body mass index(Baseline, after 30, 60 and 90 days of intervention)
- % fat(Baseline, after 30, 60 and 90 days of intervention)
- Estimated protein consumption(Baseline, after 30, 60 and 90 days of intervention)
Investigators
Andrés López Quintero
Associate Professor B
University of Guadalajara