Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia

NCT ID: NCT04379622

Last Updated: 2020-08-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-22

Study Completion Date

2020-08-05

Brief Summary

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There is objective need to evaluate the differences in dietary intake (DI), body composition (BC), lifestyle (LS) and cardiovascular diseases (CVD) risk factors between healthy and active vegetarinas (VEG) and non vegetarians (non VEG) and references (according to gender).

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).

Detailed Description

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In the study investigators will voluntarily enroll health and active 200-400 participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators anticipate that for this number of adults (aged 18-80 years) will require approx. 10-20.000 invited candidates, of both sexes.

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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Diet, Healthy Body Weight Time Restricted Feeding Sleep Cardiovascular Risk Factor Motivation

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Health and active
* 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

* Major musculoskeletal restrictions
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barbara Jakše s.p.

OTHER

Sponsor Role lead

Responsible Party

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Boštjan Jakše

PhD student of Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Slovenia

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.

Reference Type BACKGROUND
PMID: 22843611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16925881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28922262 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34199550 (View on PubMed)

Related Links

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http://www.foresoft.co.uk/

Forestfield Software Ltd. Forestfield Software - Dietplan

https://www.who.int/publications-detail/9789241549028

Guideline: sugars intake for adults and children

https://www.dge.de/wissenschaft/referenzwerte/

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).

https://pretehtajte.si/

ResPons (2020) Pretehtajte prehranska dopolnila

Other Identifiers

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KR4

Identifier Type: -

Identifier Source: org_study_id

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