Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia
NCT ID: NCT04379622
Last Updated: 2020-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
93 participants
OBSERVATIONAL
2020-05-22
2020-08-05
Brief Summary
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The aim of this cross-sectional study for investigators is to document the potential differences in DI (non adjusted and adjusted), BC, LS and CVD risk factors between healthy and active VEG and non VEG, aged from 18 to 80 years, and to evaluated correlation between DI variables and CVD risk factors.
The study during the COVID-19 pandemic period will be self-reported. As variables the investigators will include the dietary intake, BC (body height, body weight, body mass index (BMI), body fat percentage (BF %)), lifestyle status (physical activity, daily seating, hygiene of sleep, socio-economic status, and motive for practicing chosen diet). The investigators will also record their maximum (lifetime) body weight, lipids (total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides) and blood pressure (BP) status.
The investigators hypothesis are:
(H1): There are differences in DI and quality of the diet (compared with references).
(H2): There are differences in BC between the VEG in non VEG (according to gender).
(H3): The are no differences between in CVD risk factors between the VEG and non VEG (according to gender).
(H4): The are no differences in the effect of two intervals of time restricted feeding (i.e., 8-12 hours vs. 12-16 hours) within dietary pattern (according to gender).
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Detailed Description
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The methods to be used are standardized food frequency questionnaire (FFQ) that is sensible for different dietary patterns (to analyzed the daily dietary intake, for conventional component the investigators will use Dietplan7 Pro dietary assessment software (Forestield Software Limited, Horsham, UK), while for dietary supplements the investigators will use Res Pons d.o.o. servises, company that professionally manages a database with all dietary supplements and medicine products available on the Slovenian market.
BC status the investigators will use self-reported data from bioimpedance body composition monitor (Tanita, Tokyo, Japan), for basic anthropometric status the investigators will use medically approved body weight scale and body gauge (in the medical centers; body height, body weight, and BMI), and for lifestyle status the investigators will use three standardized questionnaires for: (1) habitual and organized physical activity, and the frequency of sitting (IPAQ-long), (2) quality of sleep (PSQI), and (3) socio-demographic, economic status adopted by Slovenian NIH.
Additionally, with added questionnaire the investigators will assessed the motives for VEG and non VEG dietary pattern. Investigators will record the participants maximum (lifetime) body weight (and therefore maximum BMI), and used self-reported CVD biochemistry results, measured in a standard and comparable method (plasma lipids, BP) in national medical centers.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Interventions
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Dietary intake, body composition, lifestyle, and CVD risk factors
Dietary intake, body composition, lifestyle, and CVD risk factors
Eligibility Criteria
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Inclusion Criteria
* At least one year on same dietary pattern
* Signed informed consent to participate in the study
* Measured body composition status within last 90 days in Tanita body composition anayzer
* Measured values (annual or initiative examination report) of lipids and blood pressure
Exclusion Criteria
* Pregnant and lactating woman
* Currently competitive or top level athletes
* Current use of drugs for measured blood markers (lipids and blood pressure)
* Active common chronic diseases (i.e., cancer, CVD, autoimmune diseases ect.)
* Lost 5 kg or more within last year
18 Years
80 Years
ALL
Yes
Sponsors
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Barbara Jakše s.p.
OTHER
Responsible Party
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Boštjan Jakše
PhD student of Nutrition
Principal Investigators
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Boštjan Jakše
Role: PRINCIPAL_INVESTIGATOR
Barbara Jakše s.p.
Stanislav Pinter, PhD
Role: STUDY_CHAIR
University of Ljubljana
Locations
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PDP Spodnje Črnuče
Ljubljana, , Slovenia
Countries
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References
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De Keyzer W, Dekkers A, Van Vlaslaer V, Ottevaere C, Van Oyen H, De Henauw S, Huybrechts I. Relative validity of a short qualitative food frequency questionnaire for use in food consumption surveys. Eur J Public Health. 2013 Oct;23(5):737-42. doi: 10.1093/eurpub/cks096. Epub 2012 Jul 26.
Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Fidler Mis N, Braegger C, Bronsky J, Campoy C, Domellof M, Embleton ND, Hojsak I, Hulst J, Indrio F, Lapillonne A, Mihatsch W, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition:. Sugar in Infants, Children and Adolescents: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2017 Dec;65(6):681-696. doi: 10.1097/MPG.0000000000001733.
Jakse B, Jakse B, Godnov U, Pinter S. Nutritional, Cardiovascular Health and Lifestyle Status of 'Health Conscious' Adult Vegans and Non-Vegans from Slovenia: A Cross-Sectional Self-Reported Survey. Int J Environ Res Public Health. 2021 Jun 2;18(11):5968. doi: 10.3390/ijerph18115968.
Related Links
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Forestfield Software Ltd. Forestfield Software - Dietplan
NIJZ with partners (2019).
Guideline: sugars intake for adults and children
German Nutrition Society, Austrian Nutrition Society, Swiss Society of Nutrition Research, the S. A. for N. (2018). 3. Ergaenzlieferung D-A-CH Referenzwerte für die Nährstoffzufuhr \[Reference Values for Nutrient Intake\] (4th ed).
ResPons (2020) Pretehtajte prehranska dopolnila
Other Identifiers
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KR4
Identifier Type: -
Identifier Source: org_study_id
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