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

Stress, Psychological Clinical Trial

— SuppWFPBD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976479
• Other study ID #: KR3
• Status: Completed
• Start date: May 28, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: Barbara Jakše s.p.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Disorders
• Body Weight
• Conditions Influencing Health Status
• Disease
• Lipid Metabolism Disorders
• Metabolic Diseases
• Physical Stress
• Sleep Disorder
• Sleep Wake Disorders
• Stress, Psychological
• Uricemia

Intervention

Other:
• Body composition, questionnaires, biochemistry and blood pressure results
Body composition status, nutritional status, cardiovasculat status, health status, lifestyle factors

Locations

Country	Name	City	State
Slovenia	PDP Spodnje Crnuce	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
Boštjan Jakše	University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

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). pii: E625. doi: 10.3390/nu11030625. — View Citation

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. — View Citation

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. — View Citation

Willett W, Rockström 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. Review. Erratum in: Lancet. 2019 Feb 9;393(10171):530. Erratum in: Lancet. 2019 Jun 29;393(10191):2590. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight status	Body weight measured with medically approved weighing scale	Cross-sectional (June-July 2019)
Primary	Height status	Height status measured with medically approved weighing scale with height rod	Cross-sectional (June-July 2019)
Primary	Body mass index (BMI) status	Measured weight and height will be combined to report BMI in kg/m^2	Cross-sectional (June-July 2019)
Primary	Lean tissue mass status	Lean tissue mass measured with medically approved bioimpedance analysis	Cross-sectional (June-July 2019)
Primary	Fat tissue mass status	Fat tissue mass measured with medically approved bioimpedance analysis	Cross-sectional (June-July 2019)
Primary	Nutritional status	Nutrititional status measured with 3-day dietary record (3-DR)	Cross-sectional (June-July 2019)
Primary	Serum cholesterol status	Serum total cholesterol concentration	Cross-sectional (June-July 2019)
Primary	Oxidized Low Density Lipoprotein (LDL)-cholesterol status	Serum concentration of oxidized LDL-cholesterol	Cross-sectional (June-July 2019)
Primary	Serum HDL cholesterol status	Serum HDL cholesterol contentration	Cross-sectional (June-July 2019)
Primary	Serum triglyceride status	Serum triglyceride concentrations	Cross-sectional (June-July 2019)
Primary	Blood pressure status	Blood pressure status	Cross-sectional (June-July 2019)
Secondary	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)
Secondary	Physical activity status	Physical activity status measured by The International Physical Activity Questionnaires (IPAQ)	Cross-sectional (June-July 2019)
Secondary	Stress status	Stress status measured with Perceived Stress Questionnaire (PSQ)	Cross-sectional (June-July 2019)
Secondary	Sleep status	Sleep status measured with The Pittsburgh Sleep Quality Index (PSQI)	Cross-sectional (June-July 2019)
Secondary	Serum uric acid status	Serum uric acid concentration (safety outcome)	Cross-sectional (June-July 2019)
Secondary	Hemoglobin status	Hemoglobin concentration (safety outcome)	Cross-sectional (June-July 2019)

External Links

•   EuroFIR AISBL
•   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
•   Res Pons d.o.o.