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

NCT04379622 | Completed

• 1 other identifier: KR4
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (10)

• Body weight status

  Body weight measured with medically approved weighing scale

  Cross-sectional (April-June 2020)

• Height status

  Height status measured with medically approved weighing scale with height rod

  Cross-sectional (April-June 2020)

• Body mass index (BMI) status

  Measured weight and height will be combined to report BMI in kg/m2

  Cross-sectional (April-June 2020)

• Fat tissue mass status

  Fat tissue mass measured with bioimpedance analysis

  Cross-sectional (April-June 2020)

• Dietary intake status

  Dietary intake measured by food frequency questionnaire

  Cross-sectional (May-June 2020)

• Serum cholesterol status

  Serum total cholesterol concentration

  Cross-sectional (May 2019-June 2020)

• Oxidized Low Density Lipoprotein (LDL)-cholesterol status

  Serum concentration of oxidized LDL-cholesterol

  Cross-sectional (May 2019-June 2020)

• Serum HDL cholesterol status

  Serum HDL cholesterol concentration

  Cross-sectional (May 2019-June 2020)

• Serum triglyceride status

  Serum triglyceride concentrations

  Cross-sectional (May 2019-June 2020)

• Blood pressure status

  Blood pressure status (systolic and diastolic)

  Cross-sectional (May 2019-June 2020)

Secondary Outcomes (4)

• Socio-economic and demographic status

  Cross-sectional (May-June 2020)

• Physical activity status

  Cross-sectional (May-June 2020)

• Sleep status

  Cross-sectional (May-June 2020)

• Motives for dietary pattern status

  Cross-sectional (May-June 2020)

Interventions

Dietary intake, body composition, lifestyle, and CVD risk factors OTHER

Dietary intake, body composition, lifestyle, and CVD risk factors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy and active Slovenian adults, without body mass index (BMI) limitation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Jakše s.p.: lead

Study Sites (1)

PDP Spodnje Črnuče

Ljubljana, 1000, Slovenia

Location

Related Publications (5)

• 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.

  PMID: 22843611 BACKGROUND

• Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.

  PMID: 16925881 BACKGROUND

• 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. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Fidler Mis N, Braegger C, Bronsky J, Campoy C, Domellof 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.

  PMID: 28922262 BACKGROUND

• Jakse B, Jakse B, Godnov U, Pinter S. Nutritional, Cardiovascular Health and Lifestyle Status of 'Health Conscious' Adult Vegans and Non-Vegans from Slovenia: A Cross-Sectional Self-Reported Survey. Int J Environ Res Public Health. 2021 Jun 2;18(11):5968. doi: 10.3390/ijerph18115968.

  PMID: 34199550 DERIVED

Related Links

• Forestfield Software Ltd. Forestfield Software - Dietplan
• NIJZ with partners (2019).
• Guideline: sugars intake for adults and children
• 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).
• ResPons (2020) Pretehtajte prehranska dopolnila

MeSH Terms

Conditions

Body Weight; Intermittent Fasting

Interventions

Eating; Body Composition

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution

Study Officials

• Boštjan Jakše

  Barbara Jakše s.p.

  PRINCIPAL INVESTIGATOR

• Stanislav Pinter, PhD

  University of Ljubljana

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student of Nutrition

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: May 22, 2020
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

SL (1)