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

NCT ID: NCT00800033

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-01-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Aerobic exercise training

Group Type: EXPERIMENTAL

Aerobic exercise training

Intervention Type: BEHAVIORAL

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

Resistance exercise training

Group Type: PLACEBO_COMPARATOR

Aerobic exercise training

Intervention Type: BEHAVIORAL

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

pulse diet

Pulse based diet containing peas, lentils, and beans

Group Type: EXPERIMENTAL

pulse based diet

Intervention Type: DIETARY_SUPPLEMENT

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)

Regular diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Phil Chilibeck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip D Chilibeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

PRO0822

Identifier Type: -

Identifier Source: org_study_id