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| ID | Type | Description | Link |
|---|---|---|---|
| 20-18 | Other Identifier | Universidad de Guadalajara |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VK INTERVENTION | Experimental | administration of a menu diet containing 500mcg of vitamin K (in the food selected) durinf 6 weeks. |
|
| DIETARY RECOMMENDATIONS | No Intervention | No menu administration but only recommendations for correct diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin K diet | Other | 500mcg of Vitamin K intake provided by the selection of vitamin k rich foods in the menu. |
|
| Measure | Description | Time Frame |
|---|---|---|
| vitamin K serum levels | ng/mL | basal and after 6 weeks of diet intervention |
| Cardiovascular Risk Percentage | percentage (%) | basal and after 6 weeks of diet intervention |
| insulin serum levels | mcUI/L | basal and after 6 weeks of diet intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Osteocalcin | ng/mL | basal and after 6 weeks of diet intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris M Llamas-Covarrubias, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitario de Ciencias de la Salud | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31119401 | Background | Chen HG, Sheng LT, Zhang YB, Cao AL, Lai YW, Kunutsor SK, Jiang L, Pan A. Association of vitamin K with cardiovascular events and all-cause mortality: a systematic review and meta-analysis. Eur J Nutr. 2019 Sep;58(6):2191-2205. doi: 10.1007/s00394-019-01998-3. Epub 2019 May 22. | |
| 31947821 | Background | Simes DC, Viegas CSB, Araujo N, Marreiros C. Vitamin K as a Diet Supplement with Impact in Human Health: Current Evidence in Age-Related Diseases. Nutrients. 2020 Jan 3;12(1):138. doi: 10.3390/nu12010138. |
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IPD that underlie results in a publication
6 months after publication
IPD will be shared by email request after the request review by the main researcher
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2021 | Feb 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2021 | Feb 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 29978853 | Background | Vera-Remartinez EJ, Lazaro Monge R, Granero Chinesta S, Sanchez-Alcon Rodriguez D, Planelles Ramos MV. [Cardiovascular risk factors in young adults of a penitentiary center]. Rev Esp Salud Publica. 2018 Jul 6;92:e201807037. Spanish. |
| 28356433 | Background | Shea MK, Booth SL, Weiner DE, Brinkley TE, Kanaya AM, Murphy RA, Simonsick EM, Wassel CL, Vermeer C, Kritchevsky SB; Health ABC Study. Circulating Vitamin K Is Inversely Associated with Incident Cardiovascular Disease Risk among Those Treated for Hypertension in the Health, Aging, and Body Composition Study (Health ABC). J Nutr. 2017 May;147(5):888-895. doi: 10.3945/jn.117.249375. Epub 2017 Mar 29. |
| 18614743 | Background | Yoshida M, Booth SL, Meigs JB, Saltzman E, Jacques PF. Phylloquinone intake, insulin sensitivity, and glycemic status in men and women. Am J Clin Nutr. 2008 Jul;88(1):210-5. doi: 10.1093/ajcn/88.1.210. |
| 31761961 | Background | Al-Suhaimi EA, Al-Jafary MA. Endocrine roles of vitamin K-dependent- osteocalcin in the relation between bone metabolism and metabolic disorders. Rev Endocr Metab Disord. 2020 Mar;21(1):117-125. doi: 10.1007/s11154-019-09517-9. |
| 29746744 | Result | Gaona-Pineda EB, Martinez-Tapia B, Arango-Angarita A, Valenzuela-Bravo D, Gomez-Acosta LM, Shamah-Levy T, Rodriguez-Ramirez S. [Food groups consumption and sociodemographic characteristics in Mexican population]. Salud Publica Mex. 2018 May-Jun;60(3):272-282. doi: 10.21149/8803. Spanish. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |