Skip to content

The Manitoba Personalized Lifestyle Research (TMPLR) Study

The Manitoba Personalized Lifestyle Research (TMPLR) Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03674957
Enrollment
840
Registered
2018-09-18
Start date
2016-03-31
Completion date
2019-03-31
Last updated
2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes

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.

Interventions

None listed

Sponsors

University of Manitoba
Lead SponsorOTHER
Research Manitoba
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
30 Years to 46 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percent fat massBaselineMeasured using dual-energy X-ray absorptiometry
Percent lean massBaselineMeasured using dual-energy X-ray absorptiometry
Bone mineral densityBaselineMeasured using dual-energy X-ray absorptiometry, calculated as (mg/cm\^2)

Secondary

MeasureTime frameDescription
Micronutrient intakeBaselineAssessed using dietary history questionnaire
Montreal cognitive assessment questionnaireBaselineTotal score of 30; minimum score 0; maximum score of 30
Dietary restraintBaselineScore 0-20 from Three-Factor Eating Questionnaire
Dietary disinhibitionBaselineScore 0-16 from Three-Factor Eating Questionnaire
HungerBaselineScore 0-14 from Three-Factor Eating Questionnaire
Pittsburgh sleep quality indexBaselinePittsburgh sleep quality index
Frailty status, as determined by the Modified Fried CriteriaBaselinePatients 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 30
Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)BaselineChildhood retrospective circumstances questionnaire (adapted from the US Panel Study
WeightBaselineParticipants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale
HeightBaselineMeasured, without shoes, to the nearest 0.1 cm using a stadiometer
Body mass index (BMI)BaselineCalculated as kg/m\^2
Waist circumferenceBaselineMeasured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and the iliac crest using a fibreglass tape measure
Hip circumferenceBaselineMeasured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure
Blood pressureBaselineSystolic and diastolic blood pressures are measured in triplicate, on the non-dominant arm in a sitting position using a validated oscillometric blood pressure monitor
Pulse wave velocityDay 1 and Day 2Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days
Augmentation indexDay 1 and Day 2Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days
Blood total cholesterolBaselineBlood total cholesterol
Blood low-density lipoprotein cholesterolBaselineBlood low-density lipoprotein cholesterol
Blood high-density lipoprotein cholesterolBaselineBlood high-density lipoprotein cholesterol
Blood triglyceridesBaselineBlood triglycerides
Blood glucoseBaselineBlood glucose
Blood insulinBaselineBlood insulin
Blood ureaBaselineBlood urea
Blood creatinineBaselineBlood creatinine
Blood high sensitivity C-reactive proteinBaselineBlood high sensitivity C-reactive protein
Blood aspartate aminotransferaseBaselineBlood aspartate aminotransferase
Blood alanine aminotransferaseBaselineBlood alanine aminotransferase
Blood T regulatory cellsBaselineBlood T regulatory cells
Blood leptinBaselineBlood leptin
Blood glucagonBaselineBlood glucagon
Urinary melatoninBaselineUrinary melatonin
Red blood cell fatty acidsBaselineRed blood cell fatty acids
Plasma fatty acidsBaselinePlasma fatty acids
Blood non-cholesterol sterolsBaselineBlood non-cholesterol sterols
Blood vitamin C levelsBaselineBlood vitamin C levels
Fractional cholesterol synthesis rateBaselineFractional cholesterol synthesis rate
Triglyceride synthesis rateBaselineTriglyceride synthesis rate
Gastrointestinal microbiomeBaselineMicrobiome 16S RNA sequencing
Physical activity level1 weekAssessed using accelerometers over a period of 1 week
Muscle strengthBaselineMeasured using a hand grip dynamometer
Cardiorespiratory fitnessBaselineAssessed 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
Functional walking abilityBaselineAssessed using a 5-meter gait speed test
Sleep1 weekAverage 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 factorsBaselineThis 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.
(ASA24) dietary assessment toolBaseline(ASA24) dietary assessment tool
Early life experiences by self reportBaselineAssessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics
Early life experiences by maternal reportBaselineAssessed 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 RepositoryBaselineExamples of health records include: prescriptions, physician diagnoses and hospital discharge abstracts
Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors.BaselineThis 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.
Food energy intakeBaselineAssessed using dietary history questionnaire
Macronutrient intakeBaselineAssessed using dietary history questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026