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Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Plant-Based Diet (SuppWFPBD)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Conditions Influencing Health Status Body Weight Lipid Metabolism Disorders Uricemia Blood Pressure Disorders Physical Stress Sleep Disorder Stress, Psychological | Other: Body composition, questionnaires, biochemistry and blood pressure results |
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 |
| Actual Enrollment : | 166 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet |
| Actual Study Start Date : | May 28, 2019 |
| Actual Primary Completion Date : | July 30, 2019 |
| Actual Study Completion Date : | August 30, 2019 |
- Body weight status [ Time Frame: Cross-sectional (June-July 2019) ]Body weight measured with medically approved weighing scale
- Height status [ Time Frame: Cross-sectional (June-July 2019) ]Height status measured with medically approved weighing scale with height rod
- Body mass index (BMI) status [ Time Frame: Cross-sectional (June-July 2019) ]Measured weight and height will be combined to report BMI in kg/m^2
- Lean tissue mass status [ Time Frame: Cross-sectional (June-July 2019) ]Lean tissue mass measured with medically approved bioimpedance analysis
- Fat tissue mass status [ Time Frame: Cross-sectional (June-July 2019) ]Fat tissue mass measured with medically approved bioimpedance analysis
- Nutritional status [ Time Frame: Cross-sectional (June-July 2019) ]Nutrititional status measured with 3-day dietary record (3-DR)
- Serum cholesterol status [ Time Frame: Cross-sectional (June-July 2019) ]Serum total cholesterol concentration
- Oxidized Low Density Lipoprotein (LDL)-cholesterol status [ Time Frame: Cross-sectional (June-July 2019) ]Serum concentration of oxidized LDL-cholesterol
- Serum HDL cholesterol status [ Time Frame: Cross-sectional (June-July 2019) ]Serum HDL cholesterol contentration
- Serum triglyceride status [ Time Frame: Cross-sectional (June-July 2019) ]Serum triglyceride concentrations
- Blood pressure status [ Time Frame: Cross-sectional (June-July 2019) ]Blood pressure status
- Socio-economic and demographic status [ Time Frame: Cross-sectional (June-July 2019) ]Socio-economic and demographic status measured using Nutritional behaviours of adults Slovenians from the point of of health prevention questionnaire (Slovenian NIH)
- Physical activity status [ Time Frame: Cross-sectional (June-July 2019) ]Physical activity status measured by The International Physical Activity Questionnaires (IPAQ)
- Stress status [ Time Frame: Cross-sectional (June-July 2019) ]Stress status measured with Perceived Stress Questionnaire (PSQ)
- Sleep status [ Time Frame: Cross-sectional (June-July 2019) ]Sleep status measured with The Pittsburgh Sleep Quality Index (PSQI)
- Serum uric acid status [ Time Frame: Cross-sectional (June-July 2019) ]Serum uric acid concentration (safety outcome)
- Hemoglobin status [ Time Frame: Cross-sectional (June-July 2019) ]Hemoglobin concentration (safety outcome)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 1, 2019 | ||||
| First Posted Date | June 6, 2019 | ||||
| Last Update Posted Date | December 2, 2019 | ||||
| Actual Study Start Date | May 28, 2019 | ||||
| Actual Primary Completion Date | July 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Plant-Based Diet | ||||
| Official Title | Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet | ||||
| Brief 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Heatlhy and active long-term PB dieters | ||||
| Condition |
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| Intervention | Other: Body composition, questionnaires, biochemistry and blood pressure results
Body composition status, nutritional status, cardiovasculat status, health status, lifestyle factors
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
166 | ||||
| Original Estimated Enrollment |
200 | ||||
| Actual Study Completion Date | August 30, 2019 | ||||
| Actual Primary Completion Date | July 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Slovenia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03976479 | ||||
| Other Study ID Numbers | KR3 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Boštjan Jakše, Barbara Jakše s.p. | ||||
| Study Sponsor | Boštjan Jakše | ||||
| Collaborators | University Medical Centre Ljubljana | ||||
| Investigators | Not Provided | ||||
| PRS Account | Barbara Jakše s.p. | ||||
| Verification Date | November 2019 | ||||
