HypercholesterolemiaNCT03587051
Low Versus High-glycemic Index Post-exercise Diets for Improving Metabolism and Body Composition
A study testing Low glycemic index post-exercise diet and High glycemic index post-exercise diet in people with Hypercholesterolemia, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Postprandial triglycerides are a strong risk factor for heart disease. The purpose is to assess the effects of a low-glycemic versus high-glycemic meal after 90 minute exercise sessions that are done 4 times a week for 6 weeks on postprandial triglyceride level. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Low glycemic index post-exercise diet and High glycemic index post-exercise diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2018to 30 Dec 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
- Overweight or obese (BMI 25 or greater)
Who cannot join
- Smokers
- Diabetic
- Taking medications that affect carbohydrate or lipid metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endurance Training and Post-exercise Low Glycemic Index Recovery Diet for Improving Postprandial Triglycerides
Postprandial triglycerides are a strong risk factor for heart disease. The purpose is to assess the effects of a low-glycemic versus high-glycemic meal after 90 minute exercise sessions that are done 4 times a week for 6 weeks on postprandial triglyceride level. Secondary measurements include other lipids and body composition.
Read the detailed description
The increase in triglycerides after a meal (i.e. postprandial triglycerides) is a strong risk factor for cardiovascular disease. Overweight/obese individuals have a greater triglyceride response to the same meal compared to lean individuals; therefore they are at greater risk. If exercise is performed the evening before a high-fat breakfast, the postprandial levels of triglycerides after the breakfast are reduced; however, if high glycemic index (GI) foods are consumed after the exercise session, the benefits of exercise on next-day postprandial triglycerides is negated. The investigators recently showed (HSFC funded) that consuming low GI foods after exercise is similar to fasting after exercise and superior to consumption of high GI foods for lowering next-day postprandial triglycerides. Low GI food was also superior for increasing fat oxidation, and lowering insulin, and low and very low density lipoproteins and preventing a decrease in high density lipoproteins. The benefits of an acute exercise session followed by low GI food consumption is now clear; however, it is not known whether this practice over weeks of exercise training results in accumulated and sustained benefits.
The purpose of this study is to determine the chronic effects of consuming low compared to high GI foods after exercise sessions over six weeks in overweight and obese individuals.
Twenty-four overweight and obese males and females will be randomized to consume either high or low GI foods immediately after exercise sessions (four sessions per week, 90 minutes per session, six weeks). At all other times of the day over the six weeks, they will be supplied a moderate GI diet, with calories and macronutrients based on four-day food diaries completed before the study. Two weeks before the intervention, participants will be required to go on the moderate GI diet, as a lead-in. One week into the lead-in, a baseline test will be done to determine postprandial metabolic responses (i.e. triglycerides, low and very low density lipoproteins, high density lipoproteins, insulin, and fat oxidation) after a morning high-fat breakfast. A week later, the same postprandial testing will be carried out the morning after the first exercise and post-exercise consumption of a low or high GI recovery meal. Participants will continue the training and post-exercise food consumption for the next six weeks, with postprandial measures taken again following the final exercise and feeding session. Body composition and aerobic fitness will be determined before and after the six week intervention.
The investigators hypothesize that the low GI post-exercise feeding will be superior to the high GI post-exercise feeding for reducing body fat, improving fat oxidation, and reducing postprandial triglycerides, insulin and other harmful lipids. The results of the study will provide clinicians, exercise professionals and dietitians unique and experimentally tested strategies for their clients to lose body fat and improve metabolic profiles, to reduce the risk of heart disease.
- Conditions
- Hypercholesterolemia
- Being tested
- Low glycemic index post-exercise diet, High glycemic index post-exercise diet
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index post-exercise dietDietary supplement
Feeding of a low-glycemic index, lentil meal after 90 minutes of walking exercise
High glycemic index post-exercise dietDietary supplement
Feeding of a high-glycemic index meal (i.e. instant mashed potatoes, white bread, egg whites) after 90 minutes of walking exercise
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic index post-exercise diet | Experimental | Lentil-based post-exercise meal Receives: Dietary Supplement: Low glycemic index post-exercise diet |
| High glycemic index post-exercise diet | Active comparator | Instant potato, white bread, and egg white post-exercise meal Receives: Dietary Supplement: High glycemic index post-exercise diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglycerides
Triglyceride from serum
Measured: Change from baseline to 1 week and 6 weeks
Secondary outcomes (14)
Postprandial cholesterol
Cholesterol from serum
Measured: Change from baseline to 1 week and 6 weeks
Postprandial low density lipoprotein
Low density lipoprotein from serum
Measured: Change from baseline to 1 week and 6 weeks
Postprandial high density lipoprotein
High density lipoprotein from serum
Measured: Change from baseline to 1 week and 6 weeks
Postprandial glucose
Glucose from serum
Measured: Change from baseline to 1 week and 6 weeks
Postprandial insulin
Insulin from serum
Measured: Change from baseline to 1 week and 6 weeks
Fasting Triglyceride
Triglyceride from serum
Measured: Change from baseline to 1 week and 6 weeks
Fasting cholesterol
Cholesterol from serum
Measured: Change from baseline to 1 week and 6 weeks
Fasting LDL-cholesterol
LDL from serum
Measured: Change from baseline to 1 week and 6 weeks
Fasting HDL-cholesterol
HDL from serum
Measured: Change from baseline to 1 week and 6 weeks
Fasting glucose
Glucose from serum
Measured: Change from baseline to 1 week and 6 weeks
Fasting Insulin
Insulin from serum
Measured: Change from baseline to 1 week and 6 weeks
Postprandial fat oxidation
Fat oxidation assessed by expiratory gases
Measured: Change from baseline to 1 week and 6 weeks
Fat mass
Fat mass assessed by dual energy x-ray absorptiometry
Measured: Change from baseline to 6 weeks
Waist Girth
Waist girth assessed by a measurement tape
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start15 Jul 2018
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587051
- Sponsor's protocol ID
- 17-171
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurance Training and Post-exercise Low Glycemic Index Recovery Diet for Improving Postprandial Triglycerides
- ClinicalTrials.gov ID
- NCT03587051
- Acronym / sponsor ID
- 17-171
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 16 Jul 2018 (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.
Postprandial triglycerides are a strong risk factor for heart disease. The purpose is to assess the effects of a low-glycemic versus high-glycemic meal after 90 minute exercise sessions that are done 4 times a week for 6 weeks on postprandial triglyceride level. Secondary measurements include other lipids and body composition.
Detailed description
The increase in triglycerides after a meal (i.e. postprandial triglycerides) is a strong risk factor for cardiovascular disease. Overweight/obese individuals have a greater triglyceride response to the same meal compared to lean individuals; therefore they are at greater risk. If exercise is performed the evening before a high-fat breakfast, the postprandial levels of triglycerides after the breakfast are reduced; however, if high glycemic index (GI) foods are consumed after the exercise session, the benefits of exercise on next-day postprandial triglycerides is negated. The investigators recently showed (HSFC funded) that consuming low GI foods after exercise is similar to fasting after exercise and superior to consumption of high GI foods for lowering next-day postprandial triglycerides. Low GI food was also superior for increasing fat oxidation, and lowering insulin, and low and very low density lipoproteins and preventing a decrease in high density lipoproteins. The benefits of an acute exercise session followed by low GI food consumption is now clear; however, it is not known whether this practice over weeks of exercise training results in accumulated and sustained benefits.
The purpose of this study is to determine the chronic effects of consuming low compared to high GI foods after exercise sessions over six weeks in overweight and obese individuals.
Twenty-four overweight and obese males and females will be randomized to consume either high or low GI foods immediately after exercise sessions (four sessions per week, 90 minutes per session, six weeks). At all other times of the day over the six weeks, they will be supplied a moderate GI diet, with calories and macronutrients based on four-day food diaries completed before the study. Two weeks before the intervention, participants will be required to go on the moderate GI diet, as a lead-in. One week into the lead-in, a baseline test will be done to determine postprandial metabolic responses (i.e. triglycerides, low and very low density lipoproteins, high density lipoproteins, insulin, and fat oxidation) after a morning high-fat breakfast. A week later, the same postprandial testing will be carried out the morning after the first exercise and post-exercise consumption of a low or high GI recovery meal. Participants will continue the training and post-exercise food consumption for the next six weeks, with postprandial measures taken again following the final exercise and feeding session. Body composition and aerobic fitness will be determined before and after the six week intervention.
The investigators hypothesize that the low GI post-exercise feeding will be superior to the high GI post-exercise feeding for reducing body fat, improving fat oxidation, and reducing postprandial triglycerides, insulin and other harmful lipids. The results of the study will provide clinicians, exercise professionals and dietitians unique and experimentally tested strategies for their clients to lose body fat and improve metabolic profiles, to reduce the risk of heart disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index post-exercise diet | Experimental | Dietary Supplement: Low glycemic index post-exercise dietLentil-based post-exercise meal |
| High glycemic index post-exercise diet | Active comparator | Dietary Supplement: High glycemic index post-exercise dietInstant potato, white bread, and egg white post-exercise meal |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight or obese (BMI 25 or greater)
Key exclusion criteria (3 listed)
- Smokers
- Diabetic
- Taking medications that affect carbohydrate or lipid metabolism
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 |
|---|---|---|
| Low glycemic index post-exercise dietFeeding of a low-glycemic index, lentil meal after 90 minutes of walking exercise | Dietary supplement | Low glycemic index post-exercise diet |
| High glycemic index post-exercise dietFeeding of a high-glycemic index meal (i.e. instant mashed potatoes, white bread, egg whites) after 90 minutes of walking exercise | Dietary supplement | High glycemic index post-exercise diet |
Primary outcome
Postprandial triglycerides
Time frame: Change from baseline to 1 week and 6 weeks
Triglyceride from serum
14 secondary outcomes
Postprandial cholesterol
Time frame: Change from baseline to 1 week and 6 weeks
Postprandial low density lipoprotein
Time frame: Change from baseline to 1 week and 6 weeks
Postprandial high density lipoprotein
Time frame: Change from baseline to 1 week and 6 weeks
Postprandial glucose
Time frame: Change from baseline to 1 week and 6 weeks
Postprandial insulin
Time frame: Change from baseline to 1 week and 6 weeks
Fasting Triglyceride
Time frame: Change from baseline to 1 week and 6 weeks
Fasting cholesterol
Time frame: Change from baseline to 1 week and 6 weeks
Fasting LDL-cholesterol
Time frame: Change from baseline to 1 week and 6 weeks
Fasting HDL-cholesterol
Time frame: Change from baseline to 1 week and 6 weeks
Fasting glucose
Time frame: Change from baseline to 1 week and 6 weeks
Fasting Insulin
Time frame: Change from baseline to 1 week and 6 weeks
Postprandial fat oxidation
Time frame: Change from baseline to 1 week and 6 weeks
Fat mass
Time frame: Change from baseline to 6 weeks
Waist Girth
Time frame: Change from baseline to 6 weeks
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 11 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index post-exercise diet and High glycemic index post-exercise diet in people with Hypercholesterolemia, 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 11 Jun 2020. 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?
Postprandial triglycerides (time frame: Change from baseline to 1 week and 6 weeks). 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 11 Jun 2020.