SuppWFPBD: Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Plant-Based Diet

Sponsor

Boštjan Jakše (Other)

Overall Status

Completed

CT.gov ID

NCT03976479

Collaborator

University Medical Centre Ljubljana (Other)

166

Enrollment

Location

3.1

Actual Duration (Months)

53.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Conditions Influencing Health Status Body Weight Lipid Metabolism Disorders Uricemia Blood Pressure Disorders Physical Stress Sleep Disorder Stress, Psychological	Other: Body composition, questionnaires, biochemistry and blood pressure results

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

166 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet

Actual Study Start Date :

May 28, 2019

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Aug 30, 2019

Outcome Measures

Primary Outcome Measures

Body weight status [Cross-sectional (June-July 2019)]
Body weight measured with medically approved weighing scale
Height status [Cross-sectional (June-July 2019)]
Height status measured with medically approved weighing scale with height rod
Body mass index (BMI) status [Cross-sectional (June-July 2019)]
Measured weight and height will be combined to report BMI in kg/m^2
Lean tissue mass status [Cross-sectional (June-July 2019)]
Lean tissue mass measured with medically approved bioimpedance analysis
Fat tissue mass status [Cross-sectional (June-July 2019)]
Fat tissue mass measured with medically approved bioimpedance analysis
Nutritional status [Cross-sectional (June-July 2019)]
Nutrititional status measured with 3-day dietary record (3-DR)
Serum cholesterol status [Cross-sectional (June-July 2019)]
Serum total cholesterol concentration
Oxidized Low Density Lipoprotein (LDL)-cholesterol status [Cross-sectional (June-July 2019)]
Serum concentration of oxidized LDL-cholesterol
Serum HDL cholesterol status [Cross-sectional (June-July 2019)]
Serum HDL cholesterol contentration
Serum triglyceride status [Cross-sectional (June-July 2019)]
Serum triglyceride concentrations
Blood pressure status [Cross-sectional (June-July 2019)]
Blood pressure status

Secondary Outcome Measures

Socio-economic and demographic status [Cross-sectional (June-July 2019)]
Socio-economic and demographic status measured using Nutritional behaviours of adults Slovenians from the point of of health prevention questionnaire (Slovenian NIH)
Physical activity status [Cross-sectional (June-July 2019)]
Physical activity status measured by The International Physical Activity Questionnaires (IPAQ)
Stress status [Cross-sectional (June-July 2019)]
Stress status measured with Perceived Stress Questionnaire (PSQ)
Sleep status [Cross-sectional (June-July 2019)]
Sleep status measured with The Pittsburgh Sleep Quality Index (PSQI)
Serum uric acid status [Cross-sectional (June-July 2019)]
Serum uric acid concentration (safety outcome)
Hemoglobin status [Cross-sectional (June-July 2019)]
Hemoglobin concentration (safety outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults, age from 18-80 years, on PBD longer than 0.5 years.
PB dieters who may have some kind of food intolerance or food restriction (e.g. gluten, tomato, peanuts, citrus, etc.).
No restriction on participants current BMI
Knowing (BIA measured) PB dieters baseline BM and fat %
Currently smoking tobacco products is not an exclusion criterion, but we will record it and report in demographic data

Exclusion Criteria:

Adults on PBD but with active diseases (e.g. cardiovascular diseases, type 2 diabetes, cancer, autoimmune and neurodegenerative disease ect.).
Adults on PBD with the current use of drugs for measured blood markers (lipids and blood pressure).
Without major musculoskeletal restrictions
Pregnant and lactating woman
Currently competitive or top level athletes