- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379622
Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia (SloLifestyle)
Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ljubljana, Slovenia, 1000
- PDP Spodnje Črnuče
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight status
Time Frame: Cross-sectional (April-June 2020)
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Body weight measured with medically approved weighing scale
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Cross-sectional (April-June 2020)
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Height status
Time Frame: Cross-sectional (April-June 2020)
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Height status measured with medically approved weighing scale with height rod
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Cross-sectional (April-June 2020)
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Body mass index (BMI) status
Time Frame: Cross-sectional (April-June 2020)
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Measured weight and height will be combined to report BMI in kg/m2
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Cross-sectional (April-June 2020)
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Fat tissue mass status
Time Frame: Cross-sectional (April-June 2020)
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Fat tissue mass measured with bioimpedance analysis
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Cross-sectional (April-June 2020)
|
Dietary intake status
Time Frame: Cross-sectional (May-June 2020)
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Dietary intake measured by food frequency questionnaire
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Cross-sectional (May-June 2020)
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Serum cholesterol status
Time Frame: Cross-sectional (May 2019-June 2020)
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Serum total cholesterol concentration
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Cross-sectional (May 2019-June 2020)
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Oxidized Low Density Lipoprotein (LDL)-cholesterol status
Time Frame: Cross-sectional (May 2019-June 2020)
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Serum concentration of oxidized LDL-cholesterol
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Cross-sectional (May 2019-June 2020)
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Serum HDL cholesterol status
Time Frame: Cross-sectional (May 2019-June 2020)
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Serum HDL cholesterol concentration
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Cross-sectional (May 2019-June 2020)
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Serum triglyceride status
Time Frame: Cross-sectional (May 2019-June 2020)
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Serum triglyceride concentrations
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Cross-sectional (May 2019-June 2020)
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Blood pressure status
Time Frame: Cross-sectional (May 2019-June 2020)
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Blood pressure status (systolic and diastolic)
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Cross-sectional (May 2019-June 2020)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socio-economic and demographic status
Time Frame: Cross-sectional (May-June 2020)
|
Socio-economic and demographic status measured using Nutritional behaviours of adults Slovenians from the point of of health prevention questionnaire (Slovenian National Institute of Health)
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Cross-sectional (May-June 2020)
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Physical activity status
Time Frame: Cross-sectional (May-June 2020)
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Physical activity status measured by The International Physical Activity Questionnaires
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Cross-sectional (May-June 2020)
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Sleep status
Time Frame: Cross-sectional (May-June 2020)
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Sleep status measured with The Pittsburgh Sleep Quality Index
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Cross-sectional (May-June 2020)
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Motives for dietary pattern status
Time Frame: Cross-sectional (May-June 2020)
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Motives for dietary pattern status measured by investigators questionnaire
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Cross-sectional (May-June 2020)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boštjan Jakše, Barbara Jakše s.p.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
- EFSA (2017) Dietary Reference Values for nutrients Summary report. EFSA Support Publ.
- 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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KR4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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