Metabolic SyndromePhase 3NCT00800033
Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
A Phase 3 study testing Aerobic exercise training and pulse based diet in people with Metabolic Syndrome, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Aerobic exercise training and pulse based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women over the age of 50y
Who cannot join
- allergies to beans, peas, lentils, chickpeas
- currently taking medication for blood lipids
- currently engaged in vigorous aerobic activity greater than 2 times per week
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2
About this study
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
- Being tested
- Aerobic exercise training, pulse based diet
- Keywords
- metabolic syndrome, lipids, blood pressure, body composition
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingBehavioural
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 dietDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training | Experimental | Not described Receives: Behavioral: Aerobic exercise training |
| Resistance exercise training | Placebo comparator | Not described Receives: Behavioral: Aerobic exercise training |
| pulse diet | Experimental | Pulse based diet containing peas, lentils, and beans Receives: Dietary Supplement: pulse based diet |
| Regular diet | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome score
Measured: baseline, 2 months, 3 months, 5 months
Secondary outcomes (16)
Plasma glucose
Measured: baseline, 2 months, 3 months, 5 months
Plasma insulin
Measured: baseline, 2 months, 3 months, 5 months
High density lipoproteins
Measured: baseline, 2 months, 3 months, 5 months
Triacylglycerol
Measured: baseline, 2 months, 3 months, 5 months
Waist circumference
Measured: baseline, 2 months, 3 months, 5 months
C-reactive protein
Measured: baseline, 2 months, 3 months, 5 months
Lean body mass
Measured: baseline, 2 months, 3 months, 5 months
Fat mass
Measured: baseline, 2 months, 3 months, 5 months
Whole body bone mineral
Measured: baseline, 2 months, 3 months, 5 months
Hip bone mineral
Measured: baseline, 2 months, 3 months, 5 months
Lumbar spine bone mineral
Measured: baseline, 2 months, 3 months, 5 months
Low density lipoproteins
Measured: baseline, 2 months, 3 months, 5 months
Total cholesterol
Measured: baseline, 2 months, 3 months, 5 months
Blood Pressure
Measured: baseline, 2 months, 3 months, 5 months
Aerobic fitness - modified Canadian Test of Fitness
Measured: baseline, 2 months, 3 months, 5 months
Strength
Measured: baseline, 2 months, 3 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip D Chilibeck, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800033
- Sponsor's protocol ID
- PRO0822
- Status last verified
- May 2015
- First submitted
- 26 Nov 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00800033
- Acronym / sponsor ID
- PRO0822
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, lipids, blood pressure, body composition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training | Experimental | Behavioral: Aerobic exercise training |
| Resistance exercise training | Placebo comparator | Behavioral: Aerobic exercise training |
| pulse diet | Experimental | Dietary Supplement: pulse based dietPulse based diet containing peas, lentils, and beans |
| Regular diet | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men and women over the age of 50y
Key exclusion criteria (3 listed)
- allergies to beans, peas, lentils, chickpeas
- currently taking medication for blood lipids
- currently engaged in vigorous aerobic activity greater than 2 times per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingWalking, 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 | Behavioural | Aerobic exercise training, Resistance exercise training |
| pulse based dietTwo 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) | Dietary supplement | pulse diet |
Primary outcome
Metabolic syndrome score
Time frame: baseline, 2 months, 3 months, 5 months
16 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip D Chilibeck, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aerobic exercise training and pulse based diet in people with Metabolic Syndrome, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome score (time frame: baseline, 2 months, 3 months, 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.