The Manitoba Personalized Lifestyle Research (TMPLR) Study

NCT03674957 | Terminated

• 1 other identifier: HS18951(H2015:367)
• Study Type: observational
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Cardiovascular Diseases; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

• Percent fat mass

  Measured using dual-energy X-ray absorptiometry

  Baseline

• Percent lean mass

  Measured using dual-energy X-ray absorptiometry

  Baseline

• Bone mineral density

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

  Baseline

Secondary Outcomes (51)

• (ASA24) dietary assessment tool

  Baseline

• Food energy intake

  Baseline

• Macronutrient intake

  Baseline

• Micronutrient intake

  Baseline

• Dietary restraint

  Baseline

Eligibility Criteria

• Age: 30 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Research Manitoba: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 31604781 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, serum, red blood cells, white blood cells) samples, fecal samples, urine samples

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter JH Jones, PhD

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: September 18, 2018
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 22, 2023

Record last verified: 2018-11

Locations

CA (1)