HyperlipidemiaNCT02012855
Effect of Different Types of Carbohydrates Consumed After Exercise on Blood Fat Levels
A study testing Exercise and Diet (meal type) in people with Hyperlipidemia, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for improving the blood lipid response to a subsequent meal; that is, the appearance of fat (triglyceride) in the blood is less after a meal… Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Exercise and Diet (meal type)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Aug 2015
- Phase
- Interventional
- 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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 25 or greater
- 18-44 years of age
Who cannot join
- diabetics
- smokers
- those taking medications for cholesterol or glucose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise and Glycemic Index of Carbohydrate Feeding on Postprandial Lipid Metabolism
The increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for improving the blood lipid response to a subsequent meal; that is, the appearance of fat (triglyceride) in the blood is less after a meal if endurance exercise was performed shortly before (i.e. within half a day) of the meal (Petit et al. 2003). This benefit of exercise is unfortunately negated if the after-exercise food choice to replace the calories expended during exercise is one containing high glycemic index carbohydrates. For example, if a high glycemic index carbohydrate is consumed after an evening exercise session, the exercise no longer has an effect of lowering triglyceride in the blood after a meal consumed the next morning (Harrison et al. 2009; Burton et al. 2008). Very rarely do people perform an exercise session and then fast until their next meal hours later. The more common practice is to consume food immediately after the exercise to enhance recovery and because hunger is stimulated with exercise. Consuming carbohydrate with a low glycemic index has been shown to reduce the level of fat in the blood following a subsequent meal (Gruendel et al. 2007). To date, no studies have examined the effects of consuming a low-glycemic index meal after exercise on the blood fat response to a subsequent meal. The specific objective of our research is to determine the effect of consuming low glycemic index lentils after an endurance exercise session on the blood fat (triglyceride) response to a subsequent meal. Twenty-five overweight or obese men will have their blood triglycerides measured four times over six hours after a high-fat morning meal following four different conditions, in a randomized, counterbalanced, cross-over design (i.e. the 25 subjects will each participate in all four conditions, where the order of conditions for each person is randomized): 1) After exercise (90 minutes of moderate intensity walking) is performed the evening before, followed by caloric replacement with a high-glycemic index meal (i.e. white bread and instant mashed potatoes); 2) After the same exercise is performed the evening before, followed by caloric replacement with a lentil-based meal; 3) After the same exercise is performed the evening before, followed by fasting; 4) After a no exercise/ no meal condition (i.e. control condition). In addition to measuring blood triglycerides we will measure blood insulin, free fatty acid, high density lipoproteins, low density lipoproteins, and glucose levels as these are also related to cardiovascular disease risk and may be altered with exercise and lentil consumption. We will also measure the muscle's ability to burn fat (i.e. fat oxidation) by assessing respiratory gases (oxygen consumption and carbon dioxide output) after the high-fat meal because we expect exercise and lentils to increase fat oxidation. Our expected results are that consuming lentils after endurance exercise will lower the blood triglyceride response to a subsequent meal compared to exercise alone or when high-glycemic index carbohydrates are consumed after the exercise.
- Conditions
- Hyperlipidemia
- Being tested
- Exercise, Diet (meal type)
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Diet (meal type)Other
| Study group | Role | What they receive |
|---|---|---|
| Exercise only | Experimental | 90 minutes of exercise Receives: Behavioral: Exercise |
| Exercise and high glycemic index meal | Experimental | 90 minutes of exercise followed by a high glycemic index meal matched for calories expended during the exercise Receives: Behavioral: Exercise; Other: Diet (meal type) |
| Exercise and low glycemic index meal | Experimental | 90 minutes of exercise followed by a low glycemic index meal matched for calories expended during the exercise Receives: Behavioral: Exercise; Other: Diet (meal type) |
| No exercise and no meal | No intervention | No exercise and no meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood triglycerides
Measured: Change from baseline at 6 hours
Secondary outcomes (6)
Change in blood glucose
Measured: Change from baseline at 6 hours
Change in fat oxidation
Measured: Change from baseline at 6 hours
Change in low density lipoproteins
Measured: Change from baseline at 6 hours
Change in high density lipoproteins
Measured: Change from baseline at 6 hours
Change in total cholesterol
Measured: Change from baseline at 6 hours
Change in insulin level
Measured: Change from baseline at 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip D Chilibeck, Ph.D., Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012855
- Sponsor's protocol ID
- 000041
- Status last verified
- May 2017
- First submitted
- 15 Aug 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise and Glycemic Index of Carbohydrate Feeding on Postprandial Lipid Metabolism
- ClinicalTrials.gov ID
- NCT02012855
- Acronym / sponsor ID
- 000041
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Dec 2013 (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 increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for improving the blood lipid response to a subsequent meal; that is, the appearance of fat (triglyceride) in the blood is less after a meal if endurance exercise was performed shortly before (i.e. within half a day) of the meal (Petit et al. 2003). This benefit of exercise is unfortunately negated if the after-exercise food choice to replace the calories expended during exercise is one containing high glycemic index carbohydrates. For example, if a high glycemic index carbohydrate is consumed after an evening exercise session, the exercise no longer has an effect of lowering triglyceride in the blood after a meal consumed the next morning (Harrison et al. 2009; Burton et al. 2008). Very rarely do people perform an exercise session and then fast until their next meal hours later. The more common practice is to consume food immediately after the exercise to enhance recovery and because hunger is stimulated with exercise. Consuming carbohydrate with a low glycemic index has been shown to reduce the level of fat in the blood following a subsequent meal (Gruendel et al. 2007). To date, no studies have examined the effects of consuming a low-glycemic index meal after exercise on the blood fat response to a subsequent meal. The specific objective of our research is to determine the effect of consuming low glycemic index lentils after an endurance exercise session on the blood fat (triglyceride) response to a subsequent meal. Twenty-five overweight or obese men will have their blood triglycerides measured four times over six hours after a high-fat morning meal following four different conditions, in a randomized, counterbalanced, cross-over design (i.e. the 25 subjects will each participate in all four conditions, where the order of conditions for each person is randomized): 1) After exercise (90 minutes of moderate intensity walking) is performed the evening before, followed by caloric replacement with a high-glycemic index meal (i.e. white bread and instant mashed potatoes); 2) After the same exercise is performed the evening before, followed by caloric replacement with a lentil-based meal; 3) After the same exercise is performed the evening before, followed by fasting; 4) After a no exercise/ no meal condition (i.e. control condition). In addition to measuring blood triglycerides we will measure blood insulin, free fatty acid, high density lipoproteins, low density lipoproteins, and glucose levels as these are also related to cardiovascular disease risk and may be altered with exercise and lentil consumption. We will also measure the muscle's ability to burn fat (i.e. fat oxidation) by assessing respiratory gases (oxygen consumption and carbon dioxide output) after the high-fat meal because we expect exercise and lentils to increase fat oxidation. Our expected results are that consuming lentils after endurance exercise will lower the blood triglyceride response to a subsequent meal compared to exercise alone or when high-glycemic index carbohydrates are consumed after the exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise only | Experimental | Behavioral: Exercise90 minutes of exercise |
| Exercise and high glycemic index meal | Experimental | Behavioral: Exercise, Other: Diet (meal type)90 minutes of exercise followed by a high glycemic index meal matched for calories expended during the exercise |
| Exercise and low glycemic index meal | Experimental | Behavioral: Exercise, Other: Diet (meal type)90 minutes of exercise followed by a low glycemic index meal matched for calories expended during the exercise |
| No exercise and no meal | No intervention | –No exercise and no meal |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index of 25 or greater
- 18-44 years of age
Key exclusion criteria (3 listed)
- diabetics
- smokers
- those taking medications for cholesterol or glucose
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 |
|---|---|---|
| Exercise | Behavioural | Exercise and high glycemic index meal, Exercise and low glycemic index meal, Exercise only |
| Diet (meal type) | Other | Exercise and high glycemic index meal, Exercise and low glycemic index meal |
Primary outcome
Change in blood triglycerides
Time frame: Change from baseline at 6 hours
6 secondary outcomes
Change in blood glucose
Time frame: Change from baseline at 6 hours
Change in fat oxidation
Time frame: Change from baseline at 6 hours
Change in low density lipoproteins
Time frame: Change from baseline at 6 hours
Change in high density lipoproteins
Time frame: Change from baseline at 6 hours
Change in total cholesterol
Time frame: Change from baseline at 6 hours
Change in insulin level
Time frame: Change from baseline at 6 hours
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 5 May 2017.
- Individual participant dataSharing planned: No
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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, Ph.D. 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 study testing Exercise and Diet (meal type) in people with Hyperlipidemia, 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 2 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 5 May 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in blood triglycerides (time frame: Change from baseline at 6 hours). 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 5 May 2017.