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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00800033
First received: November 26, 2008
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Behavioral: Aerobic exercise training
Dietary Supplement: pulse based diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Metabolic syndrome score [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Plasma insulin [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • High density lipoproteins [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Triacylglycerol [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Lean body mass [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Fat mass [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Whole body bone mineral [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Hip bone mineral [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Lumbar spine bone mineral [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Low density lipoproteins [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Aerobic fitness - modified Canadian Test of Fitness [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]
  • Strength [ Time Frame: baseline, 2 months, 3 months, 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic exercise training 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
Placebo Comparator: Resistance exercise training 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
Experimental: pulse diet
Pulse based diet containing peas, lentils, and beans
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)
No Intervention: Regular diet 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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800033

Locations
Canada, Saskatchewan
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5B2
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Philip D Chilibeck, PhD University of Saskatchewan
  More Information

No publications provided

Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00800033     History of Changes
Other Study ID Numbers: PRO0822
Study First Received: November 26, 2008
Last Updated: September 9, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
metabolic syndrome
lipids
blood pressure
body composition

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014