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

NCT03976479 | Completed

• 1 other identifier: KR3
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Conditions Influencing Health Status; Body Weight; Lipid Metabolism Disorders; Uricemia; Blood Pressure Disorders; Physical Stress; Sleep Disorder; Stress, Psychological

Keywords

Body composition; Nutritional status; Lipids; Blood pressure; Lifestyle factors

Outcome Measures

Primary Outcomes (11)

• Body weight status

  Body weight measured with medically approved weighing scale

  Cross-sectional (June-July 2019)

• Height status

  Height status measured with medically approved weighing scale with height rod

  Cross-sectional (June-July 2019)

• Body mass index (BMI) status

  Measured weight and height will be combined to report BMI in kg/m\^2

  Cross-sectional (June-July 2019)

• Lean tissue mass status

  Lean tissue mass measured with medically approved bioimpedance analysis

  Cross-sectional (June-July 2019)

• Fat tissue mass status

  Fat tissue mass measured with medically approved bioimpedance analysis

  Cross-sectional (June-July 2019)

• Nutritional status

  Nutrititional status measured with 3-day dietary record (3-DR)

  Cross-sectional (June-July 2019)

• Serum cholesterol status

  Serum total cholesterol concentration

  Cross-sectional (June-July 2019)

• Oxidized Low Density Lipoprotein (LDL)-cholesterol status

  Serum concentration of oxidized LDL-cholesterol

  Cross-sectional (June-July 2019)

• Serum HDL cholesterol status

  Serum HDL cholesterol contentration

  Cross-sectional (June-July 2019)

• Serum triglyceride status

  Serum triglyceride concentrations

  Cross-sectional (June-July 2019)

• Blood pressure status

  Blood pressure status

  Cross-sectional (June-July 2019)

Secondary Outcomes (6)

• Socio-economic and demographic status

  Cross-sectional (June-July 2019)

• Physical activity status

  Cross-sectional (June-July 2019)

• Stress status

  Cross-sectional (June-July 2019)

• Sleep status

  Cross-sectional (June-July 2019)

• Serum uric acid status

  Cross-sectional (June-July 2019)

Interventions

Body composition, questionnaires, biochemistry and blood pressure results OTHER

Body composition status, nutritional status, cardiovasculat status, health status, lifestyle 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

Heatlhy and active long-term PB dieters

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Boštjan Jakše: lead
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

PDP Spodnje Črnuče

Ljubljana, 1000, Slovenia

Location

Related Publications (4)

• Karlsen MC, Rogers G, Miki A, Lichtenstein AH, Folta SC, Economos CD, Jacques PF, Livingston KA, McKeown NM. Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. Nutrients. 2019 Mar 14;11(3):625. doi: 10.3390/nu11030625.

  PMID: 30875784 BACKGROUND

• Melina V, Craig W, Levin S. Position of the Academy of Nutrition and Dietetics: Vegetarian Diets. J Acad Nutr Diet. 2016 Dec;116(12):1970-1980. doi: 10.1016/j.jand.2016.09.025.

  PMID: 27886704 BACKGROUND

• Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, Rexrode KM, Rimm EB, Hu FB. Healthful and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll Cardiol. 2017 Jul 25;70(4):411-422. doi: 10.1016/j.jacc.2017.05.047.

  PMID: 28728684 BACKGROUND

• Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.

  PMID: 30660336 BACKGROUND

Related Links

• NIJZ, Slikovno-gradivo-za-dolocanje-vnosa-zivil, 2016. Available at: http://www.nijz.si/sl/publikacije/slikovno-gradivo-za-dolocanje-vnosa-zivil , assesed 30.05.2019
• OPEN Platform for Clinical Nutrition
• EuroFIR AISBL
• Res Pons d.o.o.

MeSH Terms

Conditions

Body Weight; Lipid Metabolism Disorders; Hyperuricemia; Sleep Wake Disorders; Stress, Psychological

Interventions

Body Composition; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical education teacher (Phd student of Nutrition)

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 6, 2019
• Study Start: May 28, 2019
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

SL (1)