Hyperlipemia, Carbohydrate InducibleNCT03154216
Milk as a Recovery Beverage After Exercise for Improving Metabolic Health
A study testing Exercise and Drink in people with Hyperlipemia, Carbohydrate Inducible, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Fasting blood fat levels (triglycerides) are often used to assess risk of heart disease but the level of fats in the blood after a meal is actually a stronger risk factor. Most of our day is spent digesting the food we eat (which takes hours). Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipemia, Carbohydrate Inducible
- What is being tested?
- Exercise and Drink
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2017to 1 Jan 2019
- 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
- those who are allergic to milk
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan (SK), S7N5B2
About this study
Official title: The Effect of Milk as a Recovery Beverage After Exercise on Next-day Postprandial Triglycerides
Fasting blood fat levels (triglycerides) are often used to assess risk of heart disease but the level of fats in the blood after a meal is actually a stronger risk factor. Most of our day is spent digesting the food we eat (which takes hours). Therefore, "after meal" blood fat levels have more of an impact on formation of blockages in our arteries and our risk of heart disease compared to "fasting" blood fat levels. Exercise performed hours before a meal reduces the level of fats that appear in the blood after a meal and can be used to reduce our risk of heart disease. Exercise has this effect because muscle burns fats for hours after an exercise session is over; this helps to remove fats from the blood. Unfortunately, when high-sugar drinks (such as Gatorade) are consumed after exercise, the possible benefits of exercise for reducing blood fat levels after meals is lessened. This is because high-sugar drinks stimulate the release of insulin into the blood. Insulin is a hormone which inhibits fat burning at the muscle. Previous research we did showed that foods that result in a slower rise in blood sugar and lower release of insulin preserve the beneficial effects of exercise for lowering blood fat levels after the next meal. Milk also results in a slow rise in blood sugar and low release of insulin; therefore, it may also have this beneficial effect if consumed as a recovery beverage after exercise. Our proposed research will test the effects of consuming two popular exercise-recovery drinks (Milk vs. Gatorade) on the rise in blood fat levels after a meal given hours later. A total of 20 obese or overweight participants will take part. We predict that milk consumed after an exercise session in the evening will result in a lower increase in insulin, a greater amount of fat-burning at muscle and a lower blood fat level after a meal given the next morning. Milk and Gatorade are both promoted as good beverages to promote recovery after exercise. This study will provide evidence about milk as a healthier choice compared to Gatorade and will allow dairy producers to promote health benefits of dairy products.
Read the detailed description
Cardiovascular disease is the leading cause of death in Canada with annual direct and indirect costs estimated at $22 billion. Fasting lipid levels are associated with elevated risk of cardiovascular disease; however, postprandial lipids - the level of TG after a meal, are very potent predictors of cardiovascular disease risk because most of an individual's day is spent in the postprandial state. This problem is especially evident in obese individuals, who have an elevated postprandial TG response. An acute session of exercise is beneficial for reducing postprandial TG; however, caloric consumption immediately after exercise can attenuate this beneficial effect.
Carbohydrate quality may influence postprandial lipid response. Carbohydrates can be classified by their glycemic index (GI), where high GI carbohydrates are rapidly digested and result in large elevations in blood glucose. Low GI carbohydrates are digested slowly and result in a smaller, more gradual rise in blood glucose. High GI carbohydrates are associated with an elevated risk of cardiovascular disease and increased weight gain; whereas low GI carbohydrates are associated with a reduced risk of cardiovascular disease and decreased weight gain. As mentioned above, one of the main benefits of an acute session of exercise is to reduce TG levels after a subsequent meal. For example, an evening exercise session reduces the blood TG response after a high-fat breakfast provided the next day. This effect is negated if high GI beverages (i.e. sugar-sweetened drinks) are consumed immediately after exercise. Sports drinks such as Gatorade, and skim milk or chocolate milk are the leading beverages promoted for consumption during recovery after exercise. Gatorade has a high GI (i.e. GI=89) due to the inclusion of high amounts of simple sugars, whereas milk has a low GI (i.e. GI=34). Milk may therefore be a healthier choice for consumption after exercise.
No study has determined the effects of consuming low GI milk after an exercise session on next-day postprandial TG. Considering that consuming beverages after exercise is common practice and can influence blood lipid profiles, investigation into effects of low GI milk versus high GI recovery beverages is required.
The aim of this proposal is to determine if replacing calories expended during an evening session of endurance exercise with low GI milk can improve postprandial TG after a meal the next morning. We propose to look at the effects of consuming skim milk compared to Gatorade after endurance exercise on the blood TG, other lipids, glucose levels, and blood pressure responses after a high-fat meal consumed the morning after the exercise.
Our objective is to determine the effect of consuming milk after an evening exercise session on blood triglyceride response to a high fat meal the next morning. This will be compared to: A condition where exercise is performed followed by consumption of a high glycemic index Gatorade beverage; a condition where only exercise is performed with no after-exercise caloric consumption; a condition where neither exercise nor beverage is consumed in the evening. After each of these conditions, a high fat breakfast will be consumed the following morning (about 10 hours after the end of the exercise session). Blood will be collected before the breakfast and for 6 hours after the breakfast to determine postprandial metabolic response.
Our secondary objectives are to determine the effect of each condition on postprandial insulin, high density lipoprotein, apolipoprotein B, total cholesterol, and free fatty acids, and muscle fat oxidation. Blood pressure will also be assessed immediately after the evening exercise session and beverage consumption and continue throughout the night and throughout the postprandial period the next day.
Our primary hypothesis is that consuming low glycemic index milk after the evening exercise session will be superior to consuming Gatorade for reducing postprandial triglycerides the next morning.
Our secondary hypotheses are that consuming low glycemic index milk after the evening exercise session will be superior to consuming Gatorade for improving other metabolic measures (i.e. increasing high density lipoproteins, plasma free fatty acids, and fat oxidation, and reducing apolipoprotein B, low density lipoproteins, total cholesterol, and blood pressure) during the postprandial period after a high-fat meal.
- Conditions
- Hyperlipemia, Carbohydrate Inducible
- Being tested
- Exercise, Drink
- Medical subject headings
- Hyperlipoproteinemia Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
90 minutes of moderate-intensity walking exercise on a treadmill
DrinkOther
Beverage to be consumed after exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise only | Experimental | 90 minutes of exercise Receives: Behavioral: Exercise |
| Exercise and high glycemic index drink | Experimental | 90 minutes of exercise followed by consumption of high-glycemic index Gatorade drink matched for calories expended during the exercise Receives: Behavioral: Exercise; Other: Drink |
| Exercise and low glycemic index drink | Experimental | 90 minutes of exercise followed by consumption of low-glycemic index milk drink matched for calories expended during the exercise Receives: Behavioral: Exercise; Other: Drink |
| No exercise and no beverage | No intervention | No exercise and no beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood triglycerides
Triglyceride levels after a high-fat breakfast
Measured: Change from baseline to 6 hours
Secondary outcomes (7)
Change in blood glucose
Glucose levels after a high-fat breakfast
Measured: Change from baseline to 6 hours
Change in fat oxidation
Fat oxidation after a high-fat breakfast
Measured: Change from baseline to 6 hours
Change in low density lipoproteins
Low density lipoproteins after a high-fat breakfast
Measured: Change from baseline to 6 hours
Change in high density lipoproteins
High density lipoproteins after a high fat breakfast
Measured: Change from baseline to 6 hours
Change in total cholesterol
Total cholesterol after a high-fat breakfast
Measured: Change from baseline to 6 hours
Change in insulin level
Insulin level after a high-fat breakfast
Measured: Change from baseline to 6 hours
Change in blood pressure
Blood pressure after exercise and beverage consumption
Measured: Change from baseline to 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start20 May 2017
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperlipemia, Carbohydrate InducibleStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154216
- Sponsor's protocol ID
- 16-300
- Status last verified
- May 2019
- First submitted
- 12 May 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaviani M, Chilibeck PD, Yee P, Zello GA. The effect of consuming low- versus high-glycemic index meals after exercise on postprandial blood lipid response following a next-day high-fat meal. Nutr Diabetes. 2016 Jul 4;6(7):e216. doi: 10.1038/nutd.2016.26.
PubMed 27376698Gao R, Rapin N, Elnajmi AM, Gordon J, Zello GA, Chilibeck PD. Skim milk as a recovery beverage after exercise is superior to a sports drink for reducing next-day postprandial blood glucose and increasing postprandial fat oxidation. Nutr Res. 2020 Oct;82:58-66. doi: 10.1016/j.nutres.2020.08.007. Epub 2020 Aug 19.
PubMed 32977252
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Milk as a Recovery Beverage After Exercise on Next-day Postprandial Triglycerides
- ClinicalTrials.gov ID
- NCT03154216
- Acronym / sponsor ID
- 16-300
- Conditions
- Hyperlipemia, Carbohydrate Inducible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- 20 May 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 16 May 2017 (actual)
- 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.
Fasting blood fat levels (triglycerides) are often used to assess risk of heart disease but the level of fats in the blood after a meal is actually a stronger risk factor. Most of our day is spent digesting the food we eat (which takes hours). Therefore, "after meal" blood fat levels have more of an impact on formation of blockages in our arteries and our risk of heart disease compared to "fasting" blood fat levels. Exercise performed hours before a meal reduces the level of fats that appear in the blood after a meal and can be used to reduce our risk of heart disease. Exercise has this effect because muscle burns fats for hours after an exercise session is over; this helps to remove fats from the blood. Unfortunately, when high-sugar drinks (such as Gatorade) are consumed after exercise, the possible benefits of exercise for reducing blood fat levels after meals is lessened. This is because high-sugar drinks stimulate the release of insulin into the blood. Insulin is a hormone which inhibits fat burning at the muscle. Previous research we did showed that foods that result in a slower rise in blood sugar and lower release of insulin preserve the beneficial effects of exercise for lowering blood fat levels after the next meal. Milk also results in a slow rise in blood sugar and low release of insulin; therefore, it may also have this beneficial effect if consumed as a recovery beverage after exercise. Our proposed research will test the effects of consuming two popular exercise-recovery drinks (Milk vs. Gatorade) on the rise in blood fat levels after a meal given hours later. A total of 20 obese or overweight participants will take part. We predict that milk consumed after an exercise session in the evening will result in a lower increase in insulin, a greater amount of fat-burning at muscle and a lower blood fat level after a meal given the next morning. Milk and Gatorade are both promoted as good beverages to promote recovery after exercise. This study will provide evidence about milk as a healthier choice compared to Gatorade and will allow dairy producers to promote health benefits of dairy products.
Detailed description
Cardiovascular disease is the leading cause of death in Canada with annual direct and indirect costs estimated at $22 billion. Fasting lipid levels are associated with elevated risk of cardiovascular disease; however, postprandial lipids - the level of TG after a meal, are very potent predictors of cardiovascular disease risk because most of an individual's day is spent in the postprandial state. This problem is especially evident in obese individuals, who have an elevated postprandial TG response. An acute session of exercise is beneficial for reducing postprandial TG; however, caloric consumption immediately after exercise can attenuate this beneficial effect.
Carbohydrate quality may influence postprandial lipid response. Carbohydrates can be classified by their glycemic index (GI), where high GI carbohydrates are rapidly digested and result in large elevations in blood glucose. Low GI carbohydrates are digested slowly and result in a smaller, more gradual rise in blood glucose. High GI carbohydrates are associated with an elevated risk of cardiovascular disease and increased weight gain; whereas low GI carbohydrates are associated with a reduced risk of cardiovascular disease and decreased weight gain. As mentioned above, one of the main benefits of an acute session of exercise is to reduce TG levels after a subsequent meal. For example, an evening exercise session reduces the blood TG response after a high-fat breakfast provided the next day. This effect is negated if high GI beverages (i.e. sugar-sweetened drinks) are consumed immediately after exercise. Sports drinks such as Gatorade, and skim milk or chocolate milk are the leading beverages promoted for consumption during recovery after exercise. Gatorade has a high GI (i.e. GI=89) due to the inclusion of high amounts of simple sugars, whereas milk has a low GI (i.e. GI=34). Milk may therefore be a healthier choice for consumption after exercise.
No study has determined the effects of consuming low GI milk after an exercise session on next-day postprandial TG. Considering that consuming beverages after exercise is common practice and can influence blood lipid profiles, investigation into effects of low GI milk versus high GI recovery beverages is required.
The aim of this proposal is to determine if replacing calories expended during an evening session of endurance exercise with low GI milk can improve postprandial TG after a meal the next morning. We propose to look at the effects of consuming skim milk compared to Gatorade after endurance exercise on the blood TG, other lipids, glucose levels, and blood pressure responses after a high-fat meal consumed the morning after the exercise.
Our objective is to determine the effect of consuming milk after an evening exercise session on blood triglyceride response to a high fat meal the next morning. This will be compared to: A condition where exercise is performed followed by consumption of a high glycemic index Gatorade beverage; a condition where only exercise is performed with no after-exercise caloric consumption; a condition where neither exercise nor beverage is consumed in the evening. After each of these conditions, a high fat breakfast will be consumed the following morning (about 10 hours after the end of the exercise session). Blood will be collected before the breakfast and for 6 hours after the breakfast to determine postprandial metabolic response.
Our secondary objectives are to determine the effect of each condition on postprandial insulin, high density lipoprotein, apolipoprotein B, total cholesterol, and free fatty acids, and muscle fat oxidation. Blood pressure will also be assessed immediately after the evening exercise session and beverage consumption and continue throughout the night and throughout the postprandial period the next day.
Our primary hypothesis is that consuming low glycemic index milk after the evening exercise session will be superior to consuming Gatorade for reducing postprandial triglycerides the next morning.
Our secondary hypotheses are that consuming low glycemic index milk after the evening exercise session will be superior to consuming Gatorade for improving other metabolic measures (i.e. increasing high density lipoproteins, plasma free fatty acids, and fat oxidation, and reducing apolipoprotein B, low density lipoproteins, total cholesterol, and blood pressure) during the postprandial period after a high-fat meal.
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 drink | Experimental | Behavioral: Exercise, Other: Drink90 minutes of exercise followed by consumption of high-glycemic index Gatorade drink matched for calories expended during the exercise |
| Exercise and low glycemic index drink | Experimental | Behavioral: Exercise, Other: Drink90 minutes of exercise followed by consumption of low-glycemic index milk drink matched for calories expended during the exercise |
| No exercise and no beverage | No intervention | –No exercise and no beverage |
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 (4 listed)
- diabetics
- smokers
- those taking medications for cholesterol or glucose
- those who are allergic to milk
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 |
|---|---|---|
| Exercise90 minutes of moderate-intensity walking exercise on a treadmill | Behavioural | Exercise and high glycemic index drink, Exercise and low glycemic index drink, Exercise only |
| DrinkBeverage to be consumed after exercise | Other | Exercise and high glycemic index drink, Exercise and low glycemic index drink |
Primary outcome
Change in blood triglycerides
Time frame: Change from baseline to 6 hours
Triglyceride levels after a high-fat breakfast
7 secondary outcomes
Change in blood glucose
Time frame: Change from baseline to 6 hours
Change in fat oxidation
Time frame: Change from baseline to 6 hours
Change in low density lipoproteins
Time frame: Change from baseline to 6 hours
Change in high density lipoproteins
Time frame: Change from baseline to 6 hours
Change in total cholesterol
Time frame: Change from baseline to 6 hours
Change in insulin level
Time frame: Change from baseline to 6 hours
Change in blood pressure
Time frame: Change from baseline to 16 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 7 May 2019.
- Background: PubMed 27376698Kaviani M, Chilibeck PD, Yee P, Zello GA. The effect of consuming low- versus high-glycemic index meals after exercise on postprandial blood lipid response following a next-day high-fat meal. Nutr Diabetes. 2016 Jul 4;6(7):e216. doi: 10.1038/nutd.2016.26.
- Derived from this study: PubMed 32977252Gao R, Rapin N, Elnajmi AM, Gordon J, Zello GA, Chilibeck PD. Skim milk as a recovery beverage after exercise is superior to a sports drink for reducing next-day postprandial blood glucose and increasing postprandial fat oxidation. Nutr Res. 2020 Oct;82:58-66. doi: 10.1016/j.nutres.2020.08.007. Epub 2020 Aug 19.
- 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 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 study testing Exercise and Drink in people with Hyperlipemia, Carbohydrate Inducible, 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 4 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 7 May 2019. 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 to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154216, which also lists 2 linked publications.
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 7 May 2019.