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

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ClinicalTrials.gov Identifier: NCT03976479
Recruitment Status : Completed
First Posted : June 6, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Boštjan Jakše, Barbara Jakše s.p.

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.


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

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
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

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


Primary Outcome Measures :
  1. Body weight status [ Time Frame: Cross-sectional (June-July 2019) ]
    Body weight measured with medically approved weighing scale

  2. Height status [ Time Frame: Cross-sectional (June-July 2019) ]
    Height status measured with medically approved weighing scale with height rod

  3. 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

  4. Lean tissue mass status [ Time Frame: Cross-sectional (June-July 2019) ]
    Lean tissue mass measured with medically approved bioimpedance analysis

  5. Fat tissue mass status [ Time Frame: Cross-sectional (June-July 2019) ]
    Fat tissue mass measured with medically approved bioimpedance analysis

  6. Nutritional status [ Time Frame: Cross-sectional (June-July 2019) ]
    Nutrititional status measured with 3-day dietary record (3-DR)

  7. Serum cholesterol status [ Time Frame: Cross-sectional (June-July 2019) ]
    Serum total cholesterol concentration

  8. Oxidized Low Density Lipoprotein (LDL)-cholesterol status [ Time Frame: Cross-sectional (June-July 2019) ]
    Serum concentration of oxidized LDL-cholesterol

  9. Serum HDL cholesterol status [ Time Frame: Cross-sectional (June-July 2019) ]
    Serum HDL cholesterol contentration

  10. Serum triglyceride status [ Time Frame: Cross-sectional (June-July 2019) ]
    Serum triglyceride concentrations

  11. Blood pressure status [ Time Frame: Cross-sectional (June-July 2019) ]
    Blood pressure status


Secondary Outcome Measures :
  1. 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)

  2. Physical activity status [ Time Frame: Cross-sectional (June-July 2019) ]
    Physical activity status measured by The International Physical Activity Questionnaires (IPAQ)

  3. Stress status [ Time Frame: Cross-sectional (June-July 2019) ]
    Stress status measured with Perceived Stress Questionnaire (PSQ)

  4. Sleep status [ Time Frame: Cross-sectional (June-July 2019) ]
    Sleep status measured with The Pittsburgh Sleep Quality Index (PSQI)

  5. Serum uric acid status [ Time Frame: Cross-sectional (June-July 2019) ]
    Serum uric acid concentration (safety outcome)

  6. Hemoglobin status [ Time Frame: Cross-sectional (June-July 2019) ]
    Hemoglobin concentration (safety outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Heatlhy and active long-term PB dieters
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976479


Locations
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Slovenia
PDP Spodnje Črnuče
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Boštjan Jakše
University Medical Centre Ljubljana
Additional Information:
Publications:

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Responsible Party: Boštjan Jakše, Physical education teacher (Phd student of Nutrition), Barbara Jakše s.p.
ClinicalTrials.gov Identifier: NCT03976479    
Other Study ID Numbers: KR3
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boštjan Jakše, Barbara Jakše s.p.:
Body composition
Nutritional status
Lipids
Blood pressure
Lifestyle factors
Additional relevant MeSH terms:
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Sleep Wake Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Disease
Body Weight
Stress, Psychological
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Behavioral Symptoms