Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia
- Conditions
- Cardiovascular Risk FactorDiet, HealthySleepMotivationTime Restricted FeedingBody Weight
- Registration Number
- NCT04379622
- Lead Sponsor
- Barbara Jakše s.p.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Height status Cross-sectional (April-June 2020) Height status measured with medically approved weighing scale with height rod
Fat tissue mass status Cross-sectional (April-June 2020) Fat tissue mass measured with bioimpedance analysis
Body weight status Cross-sectional (April-June 2020) Body weight measured with medically approved weighing scale
Body mass index (BMI) status Cross-sectional (April-June 2020) Measured weight and height will be combined to report BMI in kg/m2
Dietary intake status Cross-sectional (May-June 2020) Dietary intake measured by food frequency questionnaire
Serum cholesterol status Cross-sectional (May 2019-June 2020) Serum total cholesterol concentration
Serum HDL cholesterol status Cross-sectional (May 2019-June 2020) Serum HDL cholesterol concentration
Oxidized Low Density Lipoprotein (LDL)-cholesterol status Cross-sectional (May 2019-June 2020) Serum concentration of oxidized LDL-cholesterol
Serum triglyceride status Cross-sectional (May 2019-June 2020) Serum triglyceride concentrations
Blood pressure status Cross-sectional (May 2019-June 2020) Blood pressure status (systolic and diastolic)
- Secondary Outcome Measures
Name Time Method Sleep status Cross-sectional (May-June 2020) Sleep status measured with The Pittsburgh Sleep Quality Index
Motives for dietary pattern status Cross-sectional (May-June 2020) Motives for dietary pattern status measured by investigators questionnaire
Socio-economic and demographic status 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)
Physical activity status Cross-sectional (May-June 2020) Physical activity status measured by The International Physical Activity Questionnaires
Trial Locations
- Locations (1)
PDP Spodnje Črnuče
🇸🇮Ljubljana, Slovenia