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Completed

NCT Number: NCT00800033

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise Training

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 based diet

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)

Primary outcomes

  1. Metabolic syndrome score

    Time frame: baseline, 2 months, 3 months, 5 months

Secondary outcomes

  1. Plasma glucose

    Time frame: baseline, 2 months, 3 months, 5 months

  2. Plasma insulin

    Time frame: baseline, 2 months, 3 months, 5 months

  3. High density lipoproteins

    Time frame: baseline, 2 months, 3 months, 5 months

  4. Triacylglycerol

    Time frame: baseline, 2 months, 3 months, 5 months

  5. Waist circumference

    Time frame: baseline, 2 months, 3 months, 5 months

  6. C-reactive protein

    Time frame: baseline, 2 months, 3 months, 5 months

  7. Lean body mass

    Time frame: baseline, 2 months, 3 months, 5 months

  8. Fat mass

    Time frame: baseline, 2 months, 3 months, 5 months

  9. Whole body bone mineral

    Time frame: baseline, 2 months, 3 months, 5 months

  10. Hip bone mineral

    Time frame: baseline, 2 months, 3 months, 5 months

  11. Lumbar spine bone mineral

    Time frame: baseline, 2 months, 3 months, 5 months

  12. Low density lipoproteins

    Time frame: baseline, 2 months, 3 months, 5 months

  13. Total cholesterol

    Time frame: baseline, 2 months, 3 months, 5 months

  14. Blood Pressure

    Time frame: baseline, 2 months, 3 months, 5 months

  15. Aerobic fitness - modified Canadian Test of Fitness

    Time frame: baseline, 2 months, 3 months, 5 months

  16. Strength

    Time frame: baseline, 2 months, 3 months, 5 months

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2008
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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