Skip to content

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

Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04379622
Acronym
SloLifestyle
Enrollment
93
Registered
2020-05-07
Start date
2020-05-22
Completion date
2020-08-05
Last updated
2020-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

OTHERDietary intake, body composition, lifestyle, and CVD risk factors

Dietary intake, body composition, lifestyle, and CVD risk factors

Sponsors

Barbara Jakše s.p.
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure statusCross-sectional (May 2019-June 2020)Blood pressure status (systolic and diastolic)
Serum cholesterol statusCross-sectional (May 2019-June 2020)Serum total cholesterol concentration
Oxidized Low Density Lipoprotein (LDL)-cholesterol statusCross-sectional (May 2019-June 2020)Serum concentration of oxidized LDL-cholesterol
Serum HDL cholesterol statusCross-sectional (May 2019-June 2020)Serum HDL cholesterol concentration
Serum triglyceride statusCross-sectional (May 2019-June 2020)Serum triglyceride concentrations
Body weight statusCross-sectional (April-June 2020)Body weight measured with medically approved weighing scale
Height statusCross-sectional (April-June 2020)Height status measured with medically approved weighing scale with height rod
Body mass index (BMI) statusCross-sectional (April-June 2020)Measured weight and height will be combined to report BMI in kg/m2
Fat tissue mass statusCross-sectional (April-June 2020)Fat tissue mass measured with bioimpedance analysis
Dietary intake statusCross-sectional (May-June 2020)Dietary intake measured by food frequency questionnaire

Secondary

MeasureTime frameDescription
Physical activity statusCross-sectional (May-June 2020)Physical activity status measured by The International Physical Activity Questionnaires
Sleep statusCross-sectional (May-June 2020)Sleep status measured with The Pittsburgh Sleep Quality Index
Motives for dietary pattern statusCross-sectional (May-June 2020)Motives for dietary pattern status measured by investigators questionnaire
Socio-economic and demographic statusCross-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)

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026