Clinical trial NCT03674957: The Manitoba Personalized Lifestyle Research (TMPLR) Study
Official title: The Manitoba Personalized Lifestyle Research (TMPLR) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Cardiovascular Diseases
Chronic Kidney Diseases
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Research Manitoba
First posted: 2018-09-18
Enrollment: 840
Sex: ALL
Minimum age (years): 30
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A sample of 800 Manitobans aged 30-46, stratified by sex, BMI, and geography are being recruited. Participants must have lived in Manitoba for a minimum of 5 years. Women who are pregnant or lactating are not eligible to participate. Additionally, because it is expected that very few of the 800 Manitobans who join TMPLR study from the general public will have reduced kidney function (eGFR \<30 ml/min), 40 participants (20 female, 20 male, with no set stratification based on BMI or geography) who have severely reduced kidney function are being recruited from the renal health clinic at Seven Oaks General Hospital (Winnipeg, Manitoba).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percent fat mass
timeFrame: Baseline
measure: Percent lean mass
timeFrame: Baseline
measure: Bone mineral density
timeFrame: Baseline
Secondary outcomes:
measure: (ASA24) dietary assessment tool
timeFrame: Baseline
measure: Food energy intake
timeFrame: Baseline
measure: Macronutrient intake
timeFrame: Baseline
measure: Micronutrient intake
timeFrame: Baseline
measure: Dietary restraint
timeFrame: Baseline
measure: Dietary disinhibition
timeFrame: Baseline
measure: Hunger
timeFrame: Baseline
measure: Pittsburgh sleep quality index
timeFrame: Baseline
measure: Montreal cognitive assessment questionnaire
timeFrame: Baseline
measure: Frailty status, as determined by the Modified Fried Criteria
timeFrame: Baseline
measure: Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
measure: Hip circumference
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Pulse wave velocity
timeFrame: Day 1 and Day 2
measure: Augmentation index
timeFrame: Day 1 and Day 2
measure: Blood total cholesterol
timeFrame: Baseline
measure: Blood low-density lipoprotein cholesterol
timeFrame: Baseline
measure: Blood high-density lipoprotein cholesterol
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood glucose
timeFrame: Baseline
measure: Blood insulin
timeFrame: Baseline
measure: Blood urea
timeFrame: Baseline
measure: Blood creatinine
timeFrame: Baseline
measure: Blood high sensitivity C-reactive protein
timeFrame: Baseline
measure: Blood aspartate aminotransferase
timeFrame: Baseline
measure: Blood alanine aminotransferase
timeFrame: Baseline
measure: Blood T regulatory cells
timeFrame: Baseline
measure: Blood leptin
timeFrame: Baseline
measure: Blood glucagon
timeFrame: Baseline
measure: Urinary melatonin
timeFrame: Baseline
measure: Red blood cell fatty acids
timeFrame: Baseline
measure: Plasma fatty acids
timeFrame: Baseline
measure: Blood non-cholesterol sterols
timeFrame: Baseline
measure: Blood vitamin C levels
timeFrame: Baseline
measure: Fractional cholesterol synthesis rate
timeFrame: Baseline
measure: Triglyceride synthesis rate
timeFrame: Baseline
measure: Gastrointestinal microbiome
timeFrame: Baseline
measure: Physical activity level
timeFrame: 1 week
measure: Muscle strength
timeFrame: Baseline
measure: Cardiorespiratory fitness
timeFrame: Baseline
measure: Functional walking ability
timeFrame: Baseline
measure: Sleep
timeFrame: 1 week
measure: Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors
timeFrame: Baseline
measure: Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors.
timeFrame: Baseline
measure: Early life experiences by self report
timeFrame: Baseline
measure: Early life experiences by maternal report
timeFrame: Baseline
measure: Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository
timeFrame: Baseline
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter JH Jones, PhD
role: STUDY_DIRECTOR
References:
citation: Mackay D, Mollard RC, Granger M, Bruce S, Blewett H, Carlberg J, Duhamel T, Eck P, Faucher P, Hamm NC, Khafipour E, Lix L, McMillan D, Myrie S, Ravandi A, Tangri N, Azad M, Jones PJ. The Manitoba Personalized Lifestyle Research (TMPLR) study protocol: a multicentre bidirectional observational cohort study with administrative health record linkage investigating the interactions between lifestyle and health in Manitoba, Canada. BMJ Open. 2019 Oct 10;9(10):e023318. doi: 10.1136/bmjopen-2018-023318.