Hypercholesterolemia Clinical Trial
Official title:
Endurance Training and Post-exercise Low Glycemic Index Recovery Diet for Improving Postprandial Triglycerides
| NCT number | NCT03587051 |
| Other study ID # | 17-171 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 15, 2018 |
| Est. completion date | December 30, 2019 |
| Verified date | June 2020 |
| Source | University of Saskatchewan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | December 30, 2019 |
| Est. primary completion date | September 30, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 44 Years |
| Eligibility |
Inclusion Criteria: - Overweight or obese (BMI 25 or greater) Exclusion Criteria: - Smokers - Diabetic - Taking medications that affect carbohydrate or lipid metabolism |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Saskatchewan | Saskatoon | Saskatchewan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Saskatchewan | Heart and Stroke Foundation of Canada |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postprandial triglycerides | Triglyceride from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Postprandial cholesterol | Cholesterol from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Postprandial low density lipoprotein | Low density lipoprotein from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Postprandial high density lipoprotein | High density lipoprotein from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Postprandial glucose | Glucose from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Postprandial insulin | Insulin from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fasting Triglyceride | Triglyceride from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fasting cholesterol | Cholesterol from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fasting LDL-cholesterol | LDL from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fasting HDL-cholesterol | HDL from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fasting glucose | Glucose from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fasting Insulin | Insulin from serum | Change from baseline to 1 week and 6 weeks | |
| Secondary | Postprandial fat oxidation | Fat oxidation assessed by expiratory gases | Change from baseline to 1 week and 6 weeks | |
| Secondary | Fat mass | Fat mass assessed by dual energy x-ray absorptiometry | Change from baseline to 6 weeks | |
| Secondary | Waist Girth | Waist girth assessed by a measurement tape | Change from baseline to 6 weeks |
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