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Pulse-based Foods for Alleviation of Negative Consequences of Sedentary Behaviour

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ClinicalTrials.gov Identifier: NCT03941704
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Brief Summary:

The hypothesis is that consumption of pulse-based foods (i.e. containing chickpeas, lentils, and split peas) during the workday will improve insulin sensitivity, glucose tolerance, blood lipids, body composition, and blood pressure in sedentary office workers.One-hundred office workers from a university campus will participate in a cross-over study where they will be randomized (i.e. assigned by chance) to receive pre-packaged pulse-based lunches and snacks to replace their usual lunches/snacks during the work day OR to continue consuming their usual diets for two months. After the first dietary intervention, they will undergo a 1-month "wash-out" and then participate in two months of the opposite dietary intervention. The main outcome to be assessed is change in glucose and insulin (i.e. blood sugar control) determined during an oral glucose tolerance test. Secondary outcomes include changes in body composition, lipids, and blood pressure.

During the pulse-based diet phases, participants will be supplied with a ready-to-eat lunch and two snacks to eat during each workday. These will contain a total of 150g/d dry weight (250g/d wet weight) pulses


Condition or disease Intervention/treatment Phase
Insulin Sensitivity Dietary Supplement: Pulse-based diet Dietary Supplement: Regular diet Not Applicable

Detailed Description:
Sedentary behaviour has been deemed the "new smoking" based on multiple and potent negative impacts on health. Moreover, sedentary behaviour is a strong predictor of type 2 diabetes risk and cardiovascular disease. Previous studies have show that pulse-based meals derived from lentils, beans, chickpeas, and peas are effective for alleviating risk factors associated with diabetes and cardiovascular disease in clinical populations including older adults, overweight and obese individuals, and women with polycystic ovary syndrome; however, to date, there have been no nutrition-based interventions for alleviating risk factors for diabetes specifically targeting office workers exposed to long periods of sitting. Although people are aware of the health benefits of pulses, a major barrier to increased consumption continues to be a lack of knowledge on how to prepare pulse-based meals. This proposed study is designed to overcome this barrier. The main goal of this research study is to determine whether improvements in cardio-metabolic health can be realized by giving people pulse-based lunches and snacks to replace their regular workplace lunches and snacks. In this randomized controlled trial, 100 office workers from the University of Saskatchewan will participate in a cross-over study where they will be randomized into one of two diets for 2 months: Receive pre-packaged pulse-based lunches and snacks to replace their usual lunches/snacks during the work day OR to continue consuming their usual diets for two months. After a one-month washout, they will cross-over to the other condition. The primary outcome measure, Matsuda Index (determined by blood glucose and insulin responses to an oral glucose tolerance test), will be assessed before each diet phase and at the end (i.e. two months) of each diet phase. Secondary outcome measures (body composition, waist girth, lipids, blood pressure will also be assessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover: 1. Pulse-based diet; 2. Regular diet
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of Pre-Packaged Pulse-Based Meals to Ameliorate the Negative Health Consequences of Sedentary Behavior
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Glycemic Index
Pulse-based diet
Dietary Supplement: Pulse-based diet
Low Glycemic Index

Active Comparator: Moderate Glycemic Index
Regular diet
Dietary Supplement: Regular diet
Moderate Glycemic Index




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Change from baseline to 8 weeks ]
    Matsuda Index determined by glucose and insulin response to oral glucose tolerance test


Secondary Outcome Measures :
  1. Glucose area under the curve [ Time Frame: Change from baseline to 8 weeks ]
    Glucose area under the curve from a 2-hour oral glucose tolerance test

  2. Insulin area under the curve [ Time Frame: Change from baseline to 8 weeks ]
    Insulin area under the curve from a 2-hour oral glucose tolerance test

  3. Fasting glucose [ Time Frame: Change from baseline to 8 weeks ]
    Fasting glucose

  4. Fasting insulin [ Time Frame: Change from baseline to 8 weeks ]
    Fasting insulin

  5. Low-density lipoprotein cholesterol [ Time Frame: Change from baseline to 8 weeks ]
    LDL-C from fasting blood samples

  6. High-density lipoprotein cholesterol [ Time Frame: Change from baseline to 8 weeks ]
    HDL-C from fasting blood samples

  7. Total cholesterol [ Time Frame: Change from baseline to 8 weeks. ]
    Total cholesterol from fasting blood samples

  8. Triglycerides [ Time Frame: Change from baseline to 8 weeks ]
    Triglycerides from fasting blood samples

  9. Waist Girth [ Time Frame: Change from baseline to 8 weeks ]
    Waist Girth

  10. Fat mass [ Time Frame: Change from baseline to 8 weeks ]
    Fat mass from DXA measurements

  11. Lean tissue mass [ Time Frame: Change from baseline to 8 weeks ]
    Lean tissue mass from DXA measurements

  12. Systolic blood pressure [ Time Frame: Change from baseline to 8 weeks ]
    Systolic blood pressure measured at rest

  13. Diastolic blood pressure [ Time Frame: Change from baseline to 8 weeks ]
    Diastolic blood pressure measured at rest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and Women
  • 18y or older
  • Engaged in >5 hours per day sitting

Exclusion Criteria:

  • Diagnosed with diabetes
  • taking glucose or lipid-lowering medication
  • Regular consumers of pulses (1.5 cups (250g) or greater of pulses per week)
  • Engaged in 60 minutes or greater of physical activity per day

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): NCT03941704


Contacts
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Contact: Philip Chilibeck, Ph.D. 1-306-966-1072 phil.chilibeck@usask.ca
Contact: Julianne Gordon, M.Sc. 1-306-966-1082 julianne.gordon@usask.ca

Locations
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Canada, Saskatchewan
College of Kinesiology, University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N5B2
Contact: Philip Chilibeck, Ph.D.    1-306-966-1072    phil.chilibeck@usask.ca   
Contact: Julianne Gordon, M.Sc.    1-306-966-1082    julianne.gordon@usask.ca   
Sub-Investigator: Gordon Zello, Ph.D.         
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
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Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03941704    
Other Study ID Numbers: 609
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases