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Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00800033
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE November 26, 2008
First Posted Date  ICMJE December 1, 2008
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE November 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2008)
Metabolic syndrome score [ Time Frame: baseline, 2 months, 3 months, 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2008)
  • Plasma glucose [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Plasma insulin [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • High density lipoproteins [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Triacylglycerol [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Waist circumference [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • C-reactive protein [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Lean body mass [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Fat mass [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Whole body bone mineral [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Hip bone mineral [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Lumbar spine bone mineral [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Low density lipoproteins [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Total cholesterol [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Blood Pressure [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Aerobic fitness - modified Canadian Test of Fitness [ Time Frame: baseline, 2 months, 3 months, 5 months ]
  • Strength [ Time Frame: baseline, 2 months, 3 months, 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
Official Title  ICMJE Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
Brief Summary

The investigators specific objective is to determine the effectiveness of a pulse-based diet combined with an exercise training program for reducing the risk of metabolic syndrome in older adults. The metabolic syndrome is a cluster of risk factors that predispose one to the development of diabetes and cardiovascular disease. These risk factors include increased abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high blood pressure, high blood glucose and insulin levels, and increased inflammation. The investigators hypothesize that a pulse-based diet combined with exercise training will be very effective for reducing the risks of the metabolic syndrome because each intervention acts on different components of the metabolic syndrome.

The design will involve a randomized single-blind cross-over for the pulse-based diet, and a single blind randomized parallel group assignment for the exercise-based intervention. 100 subjects will be randomized to receive the pulse-based diet or their regular diet for 2 months and then cross-over to receive the opposite diet for 2 months, separated by a one-month "wash out". Subjects will be further randomized to exercise or "exercise placebo" groups for the duration of the trial (i.e. 5 months). The exercise intervention will involve aerobic training as this is most effective for reducing metabolic syndrome risk.

Dependent variables will be measured at 4 time points: baseline, after the first 2-month diet, before the second 2-month diet (i.e. after the washout) and at the end of the second 2-month diet. These variables will include: Serum triglycerides, high density lipoproteins, C-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and blood pressure. A composite metabolic syndrome score will be determined by converting each of these variables into Z-scores and determining the mean of these Z-scores. Secondary variables will include other serum lipids, including low density lipoproteins and total cholesterol.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Behavioral: Aerobic exercise training
    Walking, jogging, rowing, cycling to be done 5 times per week for 45 minutes per session (3 supervised sessions, 2 sessions at home) for 5 months
  • Dietary Supplement: pulse based diet
    Two pulse-based meals per day (lentils, beans, chickpeas, or peas) for 2 months, followed by 1-month washout and then a normal diet for 2 months (order of diets is randomized)
Study Arms  ICMJE
  • Experimental: Aerobic exercise training
    Intervention: Behavioral: Aerobic exercise training
  • Placebo Comparator: Resistance exercise training
    Intervention: Behavioral: Aerobic exercise training
  • Experimental: pulse diet
    Pulse based diet containing peas, lentils, and beans
    Intervention: Dietary Supplement: pulse based diet
  • No Intervention: Regular diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
87
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2008)
100
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • men and women over the age of 50y

Exclusion Criteria:

  • allergies to beans, peas, lentils, chickpeas
  • currently taking medication for blood lipids
  • currently engaged in vigorous aerobic activity greater than 2 times per week
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800033
Other Study ID Numbers  ICMJE PRO0822
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phil Chilibeck, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip D Chilibeck, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP