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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight; Sleep Disorder; Stress, Psychological; Lipid Metabolism Disorders; Blood Pressure Disorders; Conditions Influencing Health Status; Uricemia; Physical Stress
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • PDP Spodnje Črnuče

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Heatlhy and active long-term PB dieters

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boštjan Jakše
• Collaborators: University Medical Centre Ljubljana

Publications and helpful links

General Publications

• Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available. Erratum In: Lancet. 2019 Feb 9;393(10171):530. Lancet. 2019 Jun 29;393(10191):2590. Lancet. 2020 Feb 1;395(10221):338. Lancet. 2020 Oct 3;396(10256):e56.
• Karlsen MC, Rogers G, Miki A, Lichtenstein AH, Folta SC, Economos CD, Jacques PF, Livingston KA, McKeown NM. Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. Nutrients. 2019 Mar 14;11(3):625. doi: 10.3390/nu11030625.
• Melina V, Craig W, Levin S. Position of the Academy of Nutrition and Dietetics: Vegetarian Diets. J Acad Nutr Diet. 2016 Dec;116(12):1970-1980. doi: 10.1016/j.jand.2016.09.025.
• Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, Rexrode KM, Rimm EB, Hu FB. Healthful and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll Cardiol. 2017 Jul 25;70(4):411-422. doi: 10.1016/j.jacc.2017.05.047.

Helpful Links

• NIJZ, Slikovno-gradivo-za-dolocanje-vnosa-zivil, 2016. Available at: http://www.nijz.si/sl/publikacije/slikovno-gradivo-za-dolocanje-vnosa-zivil , assesed 30.05.2019
• OPEN Platform for Clinical Nutrition
• EuroFIR AISBL
• Res Pons d.o.o.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: June 1, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Body composition; Blood pressure; Lipids; Nutritional status; Lifestyle factors
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Sleep Wake Disorders; Stress, Psychological; Body Weight; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: KR3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No