Diet, HealthySloLifestyleNCT04379622
Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia
An observational study of Diet, Healthy and Body Weight, run by Barbara Jakše s.p. at 1 site in Slovenia.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Body Weight, Time Restricted Feeding
- What is being tested?
- Dietary intake, body composition, lifestyle, and CVD risk factors
- How many people
- 93 participants
- Where
- 1 siteSlovenia
- Study dates
- 22 May 2020to 5 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and active Slovenian adults, without body mass index (BMI) limitation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians
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.
Read more
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).
Read the detailed 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.
- Conditions
- Diet, Healthy, Body Weight, Time Restricted Feeding, Sleep, Cardiovascular Risk Factor, Motivation
- Being tested
- Dietary intake, body composition, lifestyle, and CVD risk factors
- Medical subject headings
- Body Weight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intake, body composition, lifestyle, and CVD risk factorsOther
Dietary intake, body composition, lifestyle, and CVD risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight status
Body weight measured with medically approved weighing scale
Measured: Cross-sectional (April-June 2020)
Height status
Height status measured with medically approved weighing scale with height rod
Measured: Cross-sectional (April-June 2020)
Body mass index (BMI) status
Measured weight and height will be combined to report BMI in kg/m2
Measured: Cross-sectional (April-June 2020)
Fat tissue mass status
Fat tissue mass measured with bioimpedance analysis
Measured: Cross-sectional (April-June 2020)
Dietary intake status
Dietary intake measured by food frequency questionnaire
Measured: Cross-sectional (May-June 2020)
Serum cholesterol status
Serum total cholesterol concentration
Measured: Cross-sectional (May 2019-June 2020)
Oxidized Low Density Lipoprotein (LDL)-cholesterol status
Serum concentration of oxidized LDL-cholesterol
Measured: Cross-sectional (May 2019-June 2020)
Serum HDL cholesterol status
Serum HDL cholesterol concentration
Measured: Cross-sectional (May 2019-June 2020)
Serum triglyceride status
Serum triglyceride concentrations
Measured: Cross-sectional (May 2019-June 2020)
Blood pressure status
Blood pressure status (systolic and diastolic)
Measured: Cross-sectional (May 2019-June 2020)
Secondary outcomes (4)
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)
Measured: Cross-sectional (May-June 2020)
Physical activity status
Physical activity status measured by The International Physical Activity Questionnaires
Measured: Cross-sectional (May-June 2020)
Sleep status
Sleep status measured with The Pittsburgh Sleep Quality Index
Measured: Cross-sectional (May-June 2020)
Motives for dietary pattern status
Motives for dietary pattern status measured by investigators questionnaire
Measured: Cross-sectional (May-June 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start22 May 2020
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Jakše s.p.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boštjan Jakše, Barbara Jakše s.p.
- Investigators
- Boštjan Jakše, Principal investigator, Barbara Jakše s.p.Stanislav Pinter, PhD, Study chair, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379622
- Sponsor's protocol ID
- KR4
- Acronym
- SloLifestyle
- Status last verified
- Aug 2020
- First submitted
- 5 May 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22843611Hagstromer 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.
PubMed 16925881Buysse 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.
PubMed 2748771Fidler 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.
PubMed 28922262Jakse 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.
PubMed 34199550
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians
- ClinicalTrials.gov ID
- NCT04379622
- Acronym / sponsor ID
- SloLifestyle / KR4
- Conditions
- Diet, Healthy, Body Weight, Time Restricted Feeding, Sleep, Cardiovascular Risk Factor, Motivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Barbara Jakše s.p.University, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and active Slovenian adults, without body mass index (BMI) limitation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intake, body composition, lifestyle, and CVD risk factorsDietary intake, body composition, lifestyle, and CVD risk factors | Other | – |
Primary outcome
Body weight status
Time frame: Cross-sectional (April-June 2020)
Body weight measured with medically approved weighing scale
Height status
Time frame: Cross-sectional (April-June 2020)
Height status measured with medically approved weighing scale with height rod
Body mass index (BMI) status
Time frame: Cross-sectional (April-June 2020)
Measured weight and height will be combined to report BMI in kg/m2
Fat tissue mass status
Time frame: Cross-sectional (April-June 2020)
Fat tissue mass measured with bioimpedance analysis
Dietary intake status
Time frame: Cross-sectional (May-June 2020)
Dietary intake measured by food frequency questionnaire
Serum cholesterol status
Time frame: Cross-sectional (May 2019-June 2020)
Serum total cholesterol concentration
Oxidized Low Density Lipoprotein (LDL)-cholesterol status
Time frame: Cross-sectional (May 2019-June 2020)
Serum concentration of oxidized LDL-cholesterol
Serum HDL cholesterol status
Time frame: Cross-sectional (May 2019-June 2020)
Serum HDL cholesterol concentration
Serum triglyceride status
Time frame: Cross-sectional (May 2019-June 2020)
Serum triglyceride concentrations
Blood pressure status
Time frame: Cross-sectional (May 2019-June 2020)
Blood pressure status (systolic and diastolic)
4 secondary outcomes
Socio-economic and demographic status
Time frame: Cross-sectional (May-June 2020)
Physical activity status
Time frame: Cross-sectional (May-June 2020)
Sleep status
Time frame: Cross-sectional (May-June 2020)
Motives for dietary pattern status
Time frame: Cross-sectional (May-June 2020)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 22843611De 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.
- Background: PubMed 16925881Hagstromer 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 28922262Fidler 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.
- Derived from this study: PubMed 34199550Jakse 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.
- Forestfield Software Ltd. Forestfield Software - DietplanLink provided by the sponsor.
- NIJZ with partners (2019).Link provided by the sponsor.
- Guideline: sugars intake for adults and childrenLink provided by the sponsor.
- 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).Link provided by the sponsor.
- ResPons (2020) Pretehtajte prehranska dopolnilaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boštjan Jakše principal investigator
Barbara Jakše s.p.
Stanislav Pinter, PhD study chair
University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Healthy and Body Weight, run by Barbara Jakše s.p. at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight status (time frame: Cross-sectional (April-June 2020)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379622, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.