Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia

Sleep Clinical Trial

— SloLifestyle  

Official title:

Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379622
• Other study ID #: KR4
• Status: Completed
• Start date: May 22, 2020
• Est. completion date: August 5, 2020

Study information

• Verified date: August 2020
• Source: Barbara Jakše s.p.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Cardiovascular Risk Factor
• Diet, Healthy
• Motivation
• Sleep
• Time Restricted Feeding

Intervention

Other:
• Dietary intake, body composition, lifestyle, and CVD risk factors
Dietary intake, body composition, lifestyle, and CVD risk factors

Locations

Country	Name	City	State
Slovenia	PDP Spodnje Crnuce	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Jakše s.p.

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

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. — View Citation

De Keyzer W, Dekkers A, Van Vlaslaer V, Ottevaere C, Van Oyen H, De Henauw S, Huybrechts I. Relative validity of a short qualitative food frequency questionnaire for use in food consumption surveys. Eur J Public Health. 2013 Oct;23(5):737-42. doi: 10.1093/eurpub/cks096. Epub 2012 Jul 26. — View Citation

Fidler Mis N, Braegger C, Bronsky J, Campoy C, Domellöf 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. Review. — View Citation

Hagströmer M, Oja P, Sjöström M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight status	Body weight measured with medically approved weighing scale	Cross-sectional (April-June 2020)
Primary	Height status	Height status measured with medically approved weighing scale with height rod	Cross-sectional (April-June 2020)
Primary	Body mass index (BMI) status	Measured weight and height will be combined to report BMI in kg/m2	Cross-sectional (April-June 2020)
Primary	Fat tissue mass status	Fat tissue mass measured with bioimpedance analysis	Cross-sectional (April-June 2020)
Primary	Dietary intake status	Dietary intake measured by food frequency questionnaire	Cross-sectional (May-June 2020)
Primary	Serum cholesterol status	Serum total cholesterol concentration	Cross-sectional (May 2019-June 2020)
Primary	Oxidized Low Density Lipoprotein (LDL)-cholesterol status	Serum concentration of oxidized LDL-cholesterol	Cross-sectional (May 2019-June 2020)
Primary	Serum HDL cholesterol status	Serum HDL cholesterol concentration	Cross-sectional (May 2019-June 2020)
Primary	Serum triglyceride status	Serum triglyceride concentrations	Cross-sectional (May 2019-June 2020)
Primary	Blood pressure status	Blood pressure status (systolic and diastolic)	Cross-sectional (May 2019-June 2020)
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 National Institute of Health)	Cross-sectional (May-June 2020)
Secondary	Physical activity status	Physical activity status measured by The International Physical Activity Questionnaires	Cross-sectional (May-June 2020)
Secondary	Sleep status	Sleep status measured with The Pittsburgh Sleep Quality Index	Cross-sectional (May-June 2020)
Secondary	Motives for dietary pattern status	Motives for dietary pattern status measured by investigators questionnaire	Cross-sectional (May-June 2020)

External Links

•   EFSA (2017) Dietary Reference Values for nutrients Summary report. EFSA Support Publ.
•   Forestfield Software Ltd. Forestfield Software - Dietplan
•   German Nutrition Society, Austrian Nutrition Society, Swiss Society of Nutrition Research, the S. A. for N. (2018). 3. Ergaenzlieferung D-A-CH Referenzwerte für die Nährstoffzufuhr [Reference Values for Nutrient Intake] (4th ed).
•   Guideline: sugars intake for adults and children
•   NIJZ with partners (2019).
•   ResPons (2020) Pretehtajte prehranska dopolnila