跳至主要内容
临床试验/NCT03674957
NCT03674957终止不适用

The Manitoba Personalized Lifestyle Research (TMPLR) Study

University of Manitoba1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
840
试验地点
1
主要终点
Percent fat mass

研究概览

简要总结

Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis.

详细描述

Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness and sleep. Additional factors such as medical history, socio-economic status, alcohol and tobacco consumption, cognition, stress and anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis. Participants may provide their Manitoba Personal Health Information Number (PHIN) to link their study data with administrative health records.Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness and sleep. Additional factors such as medical history, socio-economic status, alcohol and tobacco consumption, cognition, stress and anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis. Participants may provide their Manitoba Personal Health Information Number (PHIN) to link their study data with administrative health records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
30 Years 至 46 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must have lived in Manitoba for a minimum of 5 years

排除标准

  • Women who are pregnant or lactating are not eligible to participate

结局指标

主要结局

Percent fat mass

时间窗: Baseline

Measured using dual-energy X-ray absorptiometry

Percent lean mass

时间窗: Baseline

Measured using dual-energy X-ray absorptiometry

Bone mineral density

时间窗: Baseline

Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm\^2)

次要结局

  • Muscle strength(Baseline)
  • Blood pressure(Baseline)
  • Blood high-density lipoprotein cholesterol(Baseline)
  • Blood insulin(Baseline)
  • Macronutrient intake(Baseline)
  • Augmentation index(Day 1 and Day 2)
  • Blood glucose(Baseline)
  • Blood urea(Baseline)
  • Blood creatinine(Baseline)
  • Plasma fatty acids(Baseline)
  • Gastrointestinal microbiome(Baseline)
  • Physical activity level(1 week)
  • (ASA24) dietary assessment tool(Baseline)
  • Food energy intake(Baseline)
  • Micronutrient intake(Baseline)
  • Dietary restraint(Baseline)
  • Dietary disinhibition(Baseline)
  • Montreal cognitive assessment questionnaire(Baseline)
  • Frailty status, as determined by the Modified Fried Criteria(Baseline)
  • Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)(Baseline)
  • Body mass index (BMI)(Baseline)
  • Waist circumference(Baseline)
  • Pulse wave velocity(Day 1 and Day 2)
  • Blood low-density lipoprotein cholesterol(Baseline)
  • Functional walking ability(Baseline)
  • Urinary melatonin(Baseline)
  • Hunger(Baseline)
  • Height(Baseline)
  • Blood total cholesterol(Baseline)
  • Blood triglycerides(Baseline)
  • Blood high sensitivity C-reactive protein(Baseline)
  • Blood alanine aminotransferase(Baseline)
  • Blood glucagon(Baseline)
  • Early life experiences by maternal report(Baseline)
  • Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository(Baseline)
  • Pittsburgh sleep quality index(Baseline)
  • Weight(Baseline)
  • Hip circumference(Baseline)
  • Cardiorespiratory fitness(Baseline)
  • Blood aspartate aminotransferase(Baseline)
  • Blood T regulatory cells(Baseline)
  • Blood leptin(Baseline)
  • Red blood cell fatty acids(Baseline)
  • Blood non-cholesterol sterols(Baseline)
  • Fractional cholesterol synthesis rate(Baseline)
  • Blood vitamin C levels(Baseline)
  • Triglyceride synthesis rate(Baseline)
  • Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors(Baseline)
  • Sleep(1 week)
  • Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors.(Baseline)
  • Early life experiences by self report(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Manitoba Personalized Lifestyle Research (TMPLR)... | 临床试验