The Manitoba Personalized Lifestyle Research (TMPLR) Study
- Conditions
- DiabetesCardiovascular DiseasesChronic Kidney Diseases
- Registration Number
- NCT03674957
- Lead Sponsor
- University of 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 840
- Participants must have lived in Manitoba for a minimum of 5 years
- Women who are pregnant or lactating are not eligible to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent fat mass Baseline Measured using dual-energy X-ray absorptiometry
Percent lean mass Baseline Measured using dual-energy X-ray absorptiometry
Bone mineral density Baseline Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm\^2)
- Secondary Outcome Measures
Name Time Method Blood leptin Baseline Blood leptin
Blood pressure Baseline Systolic and diastolic blood pressures are measured in triplicate, on the non-dominant arm in a sitting position using a validated oscillometric blood pressure monitor
Blood high-density lipoprotein cholesterol Baseline Blood high-density lipoprotein cholesterol
Blood insulin Baseline Blood insulin
Macronutrient intake Baseline Assessed using dietary history questionnaire
Augmentation index Day 1 and Day 2 Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days
Blood glucose Baseline Blood glucose
Blood urea Baseline Blood urea
Blood creatinine Baseline Blood creatinine
Plasma fatty acids Baseline Plasma fatty acids
Gastrointestinal microbiome Baseline Microbiome 16S RNA sequencing
Physical activity level 1 week Assessed using accelerometers over a period of 1 week
Muscle strength Baseline Measured using a hand grip dynamometer
(ASA24) dietary assessment tool Baseline (ASA24) dietary assessment tool
Food energy intake Baseline Assessed using dietary history questionnaire
Micronutrient intake Baseline Assessed using dietary history questionnaire
Dietary restraint Baseline Score 0-20 from Three-Factor Eating Questionnaire
Dietary disinhibition Baseline Score 0-16 from Three-Factor Eating Questionnaire
Montreal cognitive assessment questionnaire Baseline Total score of 30; minimum score 0; maximum score of 30
Frailty status, as determined by the Modified Fried Criteria Baseline Patients meeting the criteria for ≥ 3 of the following 7 criteria are deemed frail.
1. Slowness - After two trials of a 5 m walk, average time\>6 s
2. Weakness - After three grip strength measurements with each hand, maximum value 30 kg if male or 20 kg if female
3. Weight loss - Self-reported weight loss \>4.5 kg (10 lbs) or \>5% body weight in past 12 months
4. Exhaustion - Two-item Center for Epidemiologic Studies Depression (CES-D) scale 1 out of 2
5. Depression - Five-item Geriatric Depression Scale (5-GDS) 2 out of 5
6. Low physical activity - Paffenbarger Physical Activity Index \<383 kcal per week if male or \< 270 kcal per week if female
7. Cognitive impairment - Montreal Cognitive Assessment (MoCA) score \<26 out of 30Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics) Baseline Childhood retrospective circumstances questionnaire (adapted from the US Panel Study
Body mass index (BMI) Baseline Calculated as kg/m\^2
Waist circumference Baseline Measured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and the iliac crest using a fibreglass tape measure
Pulse wave velocity Day 1 and Day 2 Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days
Blood low-density lipoprotein cholesterol Baseline Blood low-density lipoprotein cholesterol
Hunger Baseline Score 0-14 from Three-Factor Eating Questionnaire
Height Baseline Measured, without shoes, to the nearest 0.1 cm using a stadiometer
Blood total cholesterol Baseline Blood total cholesterol
Blood triglycerides Baseline Blood triglycerides
Blood high sensitivity C-reactive protein Baseline Blood high sensitivity C-reactive protein
Blood alanine aminotransferase Baseline Blood alanine aminotransferase
Blood glucagon Baseline Blood glucagon
Urinary melatonin Baseline Urinary melatonin
Functional walking ability Baseline Assessed using a 5-meter gait speed test
Early life experiences by maternal report Baseline Assessed using a mother's questionnaire (adapted from the Nurses' Health Study)
Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository Baseline Examples of health records include: prescriptions, physician diagnoses and hospital discharge abstracts
Pittsburgh sleep quality index Baseline Pittsburgh sleep quality index
Weight Baseline Participants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale
Hip circumference Baseline Measured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure
Cardiorespiratory fitness Baseline Assessed using a metabolic cart to measure oxygen consumption (VO2; mL O2/kg body weight/minute) during a submaximal YMCA bike protocol performed to 85% of age predicted heart rate max
Blood aspartate aminotransferase Baseline Blood aspartate aminotransferase
Blood T regulatory cells Baseline Blood T regulatory cells
Red blood cell fatty acids Baseline Red blood cell fatty acids
Blood non-cholesterol sterols Baseline Blood non-cholesterol sterols
Fractional cholesterol synthesis rate Baseline Fractional cholesterol synthesis rate
Blood vitamin C levels Baseline Blood vitamin C levels
Triglyceride synthesis rate Baseline Triglyceride synthesis rate
Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors Baseline This is meant to be achieved through a Genome Wide Association Study (GWAS) of Single Nucleotide Polymorphism (SNPs) associated with the measures of the lifestyle factors assessed in the TMPLR cohort, as listed in "outcome measures".
Whole genome genotyping will be conducted with a state of the art genotyping array.Sleep 1 week Average hours of sleep per night; measured using accelerometers over a period of 1 week
Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors. Baseline This is meant to be achieved targeted resequencing of target genes know to effect the metabolic traits assessed. This will aid the detection rare of Single Nucleotide Variations (SNVs) impacting the genes functions. Targeted re-sequencing will be conducted with a state of the art methodology.
Early life experiences by self report Baseline Assessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics
Trial Locations
- Locations (1)
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada