Clinical trial NCT04379622: Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia
Official title: Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet, Healthy
Body Weight
Time Restricted Feeding
Sleep
Cardiovascular Risk Factor
Motivation
Lead sponsor: Barbara Jakše s.p.
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy and active Slovenian adults, without body mass index (BMI) limitation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight status
timeFrame: Cross-sectional (April-June 2020)
measure: Height status
timeFrame: Cross-sectional (April-June 2020)
measure: Body mass index (BMI) status
timeFrame: Cross-sectional (April-June 2020)
measure: Fat tissue mass status
timeFrame: Cross-sectional (April-June 2020)
measure: Dietary intake status
timeFrame: Cross-sectional (May-June 2020)
measure: Serum cholesterol status
timeFrame: Cross-sectional (May 2019-June 2020)
measure: Oxidized Low Density Lipoprotein (LDL)-cholesterol status
timeFrame: Cross-sectional (May 2019-June 2020)
measure: Serum HDL cholesterol status
timeFrame: Cross-sectional (May 2019-June 2020)
measure: Serum triglyceride status
timeFrame: Cross-sectional (May 2019-June 2020)
measure: Blood pressure status
timeFrame: Cross-sectional (May 2019-June 2020)
Secondary outcomes:
measure: Socio-economic and demographic status
timeFrame: Cross-sectional (May-June 2020)
measure: Physical activity status
timeFrame: Cross-sectional (May-June 2020)
measure: Sleep status
timeFrame: Cross-sectional (May-June 2020)
measure: Motives for dietary pattern status
timeFrame: Cross-sectional (May-June 2020)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: PDP Spodnje Črnuče
Study officials:
affiliation: Barbara Jakše s.p.
name: Boštjan Jakše
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ljubljana
name: Stanislav Pinter, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.