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The Manitoba Personalized Lifestyle Research (TMPLR) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674957
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Research Manitoba
Information provided by (Responsible Party):
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. 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.

Condition or disease
Diabetes Cardiovascular Diseases Chronic Kidney Diseases

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Study Type : Observational
Estimated Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Manitoba Personalized Lifestyle Research (TMPLR) Study
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019



Primary Outcome Measures :
  1. Percent fat mass [ Time Frame: Baseline ]
    Measured using dual-energy X-ray absorptiometry

  2. Percent lean mass [ Time Frame: Baseline ]
    Measured using dual-energy X-ray absorptiometry

  3. Bone mineral density [ Time Frame: Baseline ]
    Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm^2)


Secondary Outcome Measures :
  1. (ASA24) dietary assessment tool [ Time Frame: Baseline ]
  2. Food energy intake [ Time Frame: Baseline ]
    Assessed using dietary history questionnaire

  3. Macronutrient intake [ Time Frame: Baseline ]
    Assessed using dietary history questionnaire

  4. Micronutrient intake [ Time Frame: Baseline ]
    Assessed using dietary history questionnaire

  5. Dietary restraint [ Time Frame: Baseline ]
    Score 0-20 from Three-Factor Eating Questionnaire

  6. Dietary disinhibition [ Time Frame: Baseline ]
    Score 0-16 from Three-Factor Eating Questionnaire

  7. Hunger [ Time Frame: Baseline ]
    Score 0-14 from Three-Factor Eating Questionnaire

  8. Pittsburgh sleep quality index [ Time Frame: Baseline ]
  9. Montreal cognitive assessment questionnaire [ Time Frame: Baseline ]
    Total score of 30; minimum score 0; maximum score of 30

  10. Frailty status, as determined by the Modified Fried Criteria [ Time Frame: 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 30

  11. Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics) [ Time Frame: Baseline ]
  12. Weight [ Time Frame: Baseline ]
    Participants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale

  13. Height [ Time Frame: Baseline ]
    Measured, without shoes, to the nearest 0.1 cm using a stadiometer

  14. Body mass index (BMI) [ Time Frame: Baseline ]
    Calculated as kg/m^2

  15. Waist circumference [ Time Frame: 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

  16. Hip circumference [ Time Frame: Baseline ]
    Measured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure

  17. Blood pressure [ Time Frame: 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

  18. Pulse wave velocity [ Time Frame: 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

  19. Augmentation index [ Time Frame: 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

  20. Blood total cholesterol [ Time Frame: Baseline ]
  21. Blood low-density lipoprotein cholesterol [ Time Frame: Baseline ]
  22. Blood high-density lipoprotein cholesterol [ Time Frame: Baseline ]
  23. Blood triglycerides [ Time Frame: Baseline ]
  24. Blood glucose [ Time Frame: Baseline ]
  25. Blood insulin [ Time Frame: Baseline ]
  26. Blood urea [ Time Frame: Baseline ]
  27. Blood creatinine [ Time Frame: Baseline ]
  28. Blood high sensitivity C-reactive protein [ Time Frame: Baseline ]
  29. Blood aspartate aminotransferase [ Time Frame: Baseline ]
  30. Blood alanine aminotransferase [ Time Frame: Baseline ]
  31. Blood T regulatory cells [ Time Frame: Baseline ]
  32. Blood leptin [ Time Frame: Baseline ]
  33. Blood glucagon [ Time Frame: Baseline ]
  34. Urinary melatonin [ Time Frame: Baseline ]
  35. Red blood cell fatty acids [ Time Frame: Baseline ]
  36. Plasma fatty acids [ Time Frame: Baseline ]
  37. Blood non-cholesterol sterols [ Time Frame: Baseline ]
  38. Blood vitamin C levels [ Time Frame: Baseline ]
  39. Fractional cholesterol synthesis rate [ Time Frame: Baseline ]
  40. Triglyceride synthesis rate [ Time Frame: Baseline ]
  41. Gastrointestinal microbiome [ Time Frame: Baseline ]
    Microbiome 16S RNA sequencing

  42. Physical activity level [ Time Frame: 1 week ]
    Assessed using accelerometers over a period of 1 week

  43. Muscle strength [ Time Frame: Baseline ]
    Measured using a hand grip dynamometer

  44. Cardiorespiratory fitness [ Time Frame: 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

  45. Functional walking ability [ Time Frame: Baseline ]
    Assessed using a 5-meter gait speed test

  46. Sleep [ Time Frame: 1 week ]
    Average hours of sleep per night; measured using accelerometers over a period of 1 week

  47. Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors [ Time Frame: 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.


  48. Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors. [ Time Frame: 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.

  49. Early life experiences by self report [ Time Frame: Baseline ]
    Assessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics

  50. Early life experiences by maternal report [ Time Frame: Baseline ]
    Assessed using a mother's questionnaire (adapted from the Nurses' Health Study)

  51. Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository [ Time Frame: Baseline ]
    Examples of health records include: prescriptions, physician diagnoses and hospital discharge abstracts


Biospecimen Retention:   Samples With DNA
Blood (plasma, serum, red blood cells, white blood cells) samples, fecal samples, urine samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 46 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674957


Locations
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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5
Sponsors and Collaborators
University of Manitoba
Research Manitoba
Investigators
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Study Director: Peter JH Jones, PhD University of Manitoba
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03674957    
Other Study ID Numbers: HS18951(H2015:367)
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency