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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Aerobic exercise training; Dietary supplement: pulse based diet

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5B2
      • College of Kinesiology, University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular diet
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic syndrome score	baseline, 2 months, 3 months, 5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma glucose	baseline, 2 months, 3 months, 5 months
Plasma insulin	baseline, 2 months, 3 months, 5 months
High density lipoproteins	baseline, 2 months, 3 months, 5 months
Triacylglycerol	baseline, 2 months, 3 months, 5 months
Waist circumference	baseline, 2 months, 3 months, 5 months
C-reactive protein	baseline, 2 months, 3 months, 5 months
Lean body mass	baseline, 2 months, 3 months, 5 months
Fat mass	baseline, 2 months, 3 months, 5 months
Whole body bone mineral	baseline, 2 months, 3 months, 5 months
Hip bone mineral	baseline, 2 months, 3 months, 5 months
Lumbar spine bone mineral	baseline, 2 months, 3 months, 5 months
Low density lipoproteins	baseline, 2 months, 3 months, 5 months
Total cholesterol	baseline, 2 months, 3 months, 5 months
Blood Pressure	baseline, 2 months, 3 months, 5 months
Aerobic fitness - modified Canadian Test of Fitness	baseline, 2 months, 3 months, 5 months
Strength	baseline, 2 months, 3 months, 5 months

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Philip D Chilibeck, PhD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 26, 2008
• First Submitted That Met QC Criteria: November 28, 2008
• First Posted (Estimate): December 1, 2008

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: blood pressure; body composition; metabolic syndrome; lipids
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: PRO0822