Stress, Psychological Clinical Trial
Official title:
Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet
There is an objective lack of data on the body composition, nutritional status,
cardiovascular status and lifestyle of adults on a plant-based diet (PBD). The aim in this
cross-sectional study investigators will document the differences in the body composition,
nutritional intake and general health status of healthy adults aged 18 to 80 years who are on
plant-based diet of 0.5-10 years and to determine if their body composition status is
associated to the duration of eating with PBD between the 3 groups: those that are 0.5-2
years (short-term), 2-5 years (medium-term) and 5-10 years (long-term) on PBD.
This study will also include the monitoring of other factors of healthy and active lifestyle
of PBD participants, namely the status of habitual and organized physical activity, the
status of daily long-term seating, the status of stress and hygiene of sleep, socio-economic
status and the motive(s)/reasons for starting PBD. Investigators will also record their
maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data
from participants, blood analysis to collect their basic biochemistry results, and data on
current blood pressure status.
The investigators hypothesis is that:
(H1): There are no differences in nutritional status between people who are short- (0.5-2
years), the medium- (2-5 years) or the long-term (5-10 years) on PBD.
(H2): At least 80% of the tested subjects have plasma lipid values and blood pressure within
the reference values.
(H3): There is difference in lipid profile and body composition between people who are short-
and the medium but not between medium and long-term PBD.
In the study investigators will voluntarily enroll all participants within
inclusion/exclusion criteria that are willing to participate in the study. Investigators will
anticipate that for approx. 150-200 healthy adult PBD participants investigators will require
approx. 2555 invited and interviewed candidates, of both sexes, aged 18-80 years, without
restrictions on current body mass index (BMI) status, that are on PBD for 0.5-10 years and
live a healthy and active lifestyle.
The methods to be used are a medically approved bioimpedance body composition monitor
(Tanita, 780 S MA, Tokyo, Japan), medically approved body weight scale and body height gauge
(MPE 250K100HM), a 3-day dietary record (3-DR), one adopted by NIH: socio-demographic,
economic status and motive for PBD questionnaire, and three standardized questionnaires: (1)
habitual and organized physical activity, and the frequency of sitting (IPAQ-long), (2)
stress (PSQ-30), and (3) quality of sleep (PSQI).
Concerning 3-DR, the study participants will weight and record all foods, beverages consumed,
as well as leftovers, and dietary supplements over three consecutive days (two weekdays and
one weekend) using electronic kitchen scales. The study participants will choose the day of
the beginning of dietary recording within a given period (i. e.: Sunday, Monday, Tuesday or
Thursday, Friday, Saturday). When exact weighing will not be possible (e.g., in case of
eating out), household measures (spoon, cup, glass, etc.) and a picture book with household
measures in adults' portion sizes (photos of reference foods with their actual gram weight)
(NIJZ, 2016), allowed semi-quantitative recording. For the evaluation of dietary intake,
investigators will use dietary software, Open Platform for Clinical Nutrition (OPEN), which
is a web-based application (http://opkp.si/) and has been developed by the Jozef Stefan
Institute and supported by the EuroFIR AISBL (http://eurofir.org) and the European Federation
of the Association of Dietitians (EFAD). Dietary software has been upgraded to 3-DR
methodology.
Food intake data (from 3-DR) will be used for assessment of energy, macro- and micronutrients
intakes using OPEN. The energy and nutrient contents of commercial food or home prepared
foods, will estimated by recipe simulation using labelled ingredients and nutrient contents.
OPEN will be continuously updated by adding those products or recopies recorded by study
participants on PBD.
In order to assess the nutritional intake from dietary supplements, we will use Res-Pons
d.o.o. services, which professionally manages the database with all dietary supplements
products on the Slovenian market (Pretehtajte.si, 2018).
Investigators will also record their maximum (lifetime) body weight, body weight upon
entering the PBD lifestyle, and using data taken blood analysis to collect their basic
biochemistry results, measured in a standard and comparable method (plasma lipids, uric acid
and a hemogram), and data on current blood pressure status.
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