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

Sponsor
Barbara Jakše s.p. (Other)
Overall Status
Completed
CT.gov ID
NCT04379622
Collaborator
(none)
93
1
2.5
37.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary intake, body composition, lifestyle, and CVD risk factors

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 Design

Study Type:
Observational
Actual Enrollment :
93 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians
Actual Study Start Date :
May 22, 2020
Actual Primary Completion Date :
Aug 5, 2020
Actual Study Completion Date :
Aug 5, 2020

Outcome Measures

Primary Outcome Measures

  1. Body weight status [Cross-sectional (April-June 2020)]

    Body weight measured with medically approved weighing scale

  2. Height status [Cross-sectional (April-June 2020)]

    Height status measured with medically approved weighing scale with height rod

  3. Body mass index (BMI) status [Cross-sectional (April-June 2020)]

    Measured weight and height will be combined to report BMI in kg/m2

  4. Fat tissue mass status [Cross-sectional (April-June 2020)]

    Fat tissue mass measured with bioimpedance analysis

  5. Dietary intake status [Cross-sectional (May-June 2020)]

    Dietary intake measured by food frequency questionnaire

  6. Serum cholesterol status [Cross-sectional (May 2019-June 2020)]

    Serum total cholesterol concentration

  7. Oxidized Low Density Lipoprotein (LDL)-cholesterol status [Cross-sectional (May 2019-June 2020)]

    Serum concentration of oxidized LDL-cholesterol

  8. Serum HDL cholesterol status [Cross-sectional (May 2019-June 2020)]

    Serum HDL cholesterol concentration

  9. Serum triglyceride status [Cross-sectional (May 2019-June 2020)]

    Serum triglyceride concentrations

  10. Blood pressure status [Cross-sectional (May 2019-June 2020)]

    Blood pressure status (systolic and diastolic)

Secondary Outcome Measures

  1. 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)

  2. Physical activity status [Cross-sectional (May-June 2020)]

    Physical activity status measured by The International Physical Activity Questionnaires

  3. Sleep status [Cross-sectional (May-June 2020)]

    Sleep status measured with The Pittsburgh Sleep Quality Index

  4. Motives for dietary pattern status [Cross-sectional (May-June 2020)]

    Motives for dietary pattern status measured by investigators questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PDP Spodnje Črnuče Ljubljana Slovenia 1000

Sponsors and Collaborators

  • Barbara Jakše s.p.

Investigators

  • Principal Investigator: Boštjan Jakše, Barbara Jakše s.p.
  • Study Chair: Stanislav Pinter, PhD, University of Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Boštjan Jakše, PhD student of Nutrition, Barbara Jakše s.p.
ClinicalTrials.gov Identifier:
NCT04379622
Other Study ID Numbers:
  • KR4
First Posted:
May 7, 2020
Last Update Posted:
Aug 6, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2020