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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

Canada1 site
  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 5B2

Other trials in Canada

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 groups in NCT02012855
Study groupRoleWhat they receive
Exercise onlyExperimental90 minutes of exercise
Receives: Behavioral: Exercise
Exercise and high glycemic index mealExperimental90 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 mealExperimental90 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 mealNo interventionNo exercise and no meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood triglycerides

    Measured: Change from baseline at 6 hours

Secondary outcomes (6)
  1. Change in blood glucose

    Measured: Change from baseline at 6 hours

  2. Change in fat oxidation

    Measured: Change from baseline at 6 hours

  3. Change in low density lipoproteins

    Measured: Change from baseline at 6 hours

  4. Change in high density lipoproteins

    Measured: Change from baseline at 6 hours

  5. Change in total cholesterol

    Measured: Change from baseline at 6 hours

  6. 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.

  1. First posted16 Dec 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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)
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

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.

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