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临床试验/NCT04379622
NCT04379622已完成不适用

Differences in Dietary Intake, Body Composition, Lifestyle and Various Cardiovascular Diseases Risk Factors Among Healthy and Active Vegetrians and Non Vegetarians

Barbara Jakše s.p.1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
1
主要终点
Height status

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Height status

时间窗: Cross-sectional (April-June 2020)

Height status measured with medically approved weighing scale with height rod

Fat tissue mass status

时间窗: Cross-sectional (April-June 2020)

Fat tissue mass measured with bioimpedance analysis

Body weight status

时间窗: Cross-sectional (April-June 2020)

Body weight measured with medically approved weighing scale

Dietary intake status

时间窗: Cross-sectional (May-June 2020)

Dietary intake measured by food frequency questionnaire

Body mass index (BMI) status

时间窗: Cross-sectional (April-June 2020)

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

Serum cholesterol status

时间窗: Cross-sectional (May 2019-June 2020)

Serum total cholesterol concentration

Serum HDL cholesterol status

时间窗: Cross-sectional (May 2019-June 2020)

Serum HDL cholesterol concentration

Oxidized Low Density Lipoprotein (LDL)-cholesterol status

时间窗: Cross-sectional (May 2019-June 2020)

Serum concentration of oxidized LDL-cholesterol

Serum triglyceride status

时间窗: Cross-sectional (May 2019-June 2020)

Serum triglyceride concentrations

Blood pressure status

时间窗: Cross-sectional (May 2019-June 2020)

Blood pressure status (systolic and diastolic)

次要结局

  • Sleep status(Cross-sectional (May-June 2020))
  • Motives for dietary pattern status(Cross-sectional (May-June 2020))
  • Socio-economic and demographic status(Cross-sectional (May-June 2020))
  • Physical activity status(Cross-sectional (May-June 2020))

研究者

发起方
Barbara Jakše s.p.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Boštjan Jakše

PhD student of Nutrition

Barbara Jakše s.p.

研究点 (1)

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