AzTrials
AzTrials

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.

Completed

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

Official record
Search all trials

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.

Canada1 site
  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 5B2

Other trials in Canada

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.

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 groups in NCT03587051
Study groupRoleWhat they receive
Low glycemic index post-exercise dietExperimentalLentil-based post-exercise meal
Receives: Dietary Supplement: Low glycemic index post-exercise diet
High glycemic index post-exercise dietActive comparatorInstant 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.

  1. Postprandial triglycerides

    Triglyceride from serum

    Measured: Change from baseline to 1 week and 6 weeks

Secondary outcomes (14)
  1. Postprandial cholesterol

    Cholesterol from serum

    Measured: Change from baseline to 1 week and 6 weeks

  2. Postprandial low density lipoprotein

    Low density lipoprotein from serum

    Measured: Change from baseline to 1 week and 6 weeks

  3. Postprandial high density lipoprotein

    High density lipoprotein from serum

    Measured: Change from baseline to 1 week and 6 weeks

  4. Postprandial glucose

    Glucose from serum

    Measured: Change from baseline to 1 week and 6 weeks

  5. Postprandial insulin

    Insulin from serum

    Measured: Change from baseline to 1 week and 6 weeks

  6. Fasting Triglyceride

    Triglyceride from serum

    Measured: Change from baseline to 1 week and 6 weeks

  7. Fasting cholesterol

    Cholesterol from serum

    Measured: Change from baseline to 1 week and 6 weeks

  8. Fasting LDL-cholesterol

    LDL from serum

    Measured: Change from baseline to 1 week and 6 weeks

  9. Fasting HDL-cholesterol

    HDL from serum

    Measured: Change from baseline to 1 week and 6 weeks

  10. Fasting glucose

    Glucose from serum

    Measured: Change from baseline to 1 week and 6 weeks

  11. Fasting Insulin

    Insulin from serum

    Measured: Change from baseline to 1 week and 6 weeks

  12. Postprandial fat oxidation

    Fat oxidation assessed by expiratory gases

    Measured: Change from baseline to 1 week and 6 weeks

  13. Fat mass

    Fat mass assessed by dual energy x-ray absorptiometry

    Measured: Change from baseline to 6 weeks

  14. 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.

  1. First posted16 Jul 2018
  2. Study start15 Jul 2018
  3. Primary completion30 Sep 2019
  4. Study completion30 Dec 2019

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT03587051 | AzTrials