Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Versus High-glycemic Index Post-exercise Diets for Improving Metabolism and Body Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587051
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Brief 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. Secondary measurements include other lipids and body composition.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Low glycemic index post-exercise diet Dietary Supplement: High glycemic index post-exercise diet Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Endurance Training and Post-exercise Low Glycemic Index Recovery Diet for Improving Postprandial Triglycerides
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low glycemic index post-exercise diet
Lentil-based post-exercise meal
Dietary Supplement: Low glycemic index post-exercise diet
Feeding of a low-glycemic index, lentil meal after 90 minutes of walking exercise

Active Comparator: High glycemic index post-exercise diet
Instant potato, white bread, and egg white post-exercise meal
Dietary Supplement: High glycemic index post-exercise diet
Feeding of a high-glycemic index meal (i.e. instant mashed potatoes, white bread, egg whites) after 90 minutes of walking exercise




Primary Outcome Measures :
  1. Postprandial triglycerides [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Triglyceride from serum


Secondary Outcome Measures :
  1. Postprandial cholesterol [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Cholesterol from serum

  2. Postprandial low density lipoprotein [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Low density lipoprotein from serum

  3. Postprandial high density lipoprotein [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    High density lipoprotein from serum

  4. Postprandial glucose [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Glucose from serum

  5. Postprandial insulin [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Insulin from serum

  6. Fasting Triglyceride [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Triglyceride from serum

  7. Fasting cholesterol [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Cholesterol from serum

  8. Fasting LDL-cholesterol [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    LDL from serum

  9. Fasting HDL-cholesterol [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    HDL from serum

  10. Fasting glucose [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Glucose from serum

  11. Fasting Insulin [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Insulin from serum

  12. Postprandial fat oxidation [ Time Frame: Change from baseline to 1 week and 6 weeks ]
    Fat oxidation assessed by expiratory gases

  13. Fat mass [ Time Frame: Change from baseline to 6 weeks ]
    Fat mass assessed by dual energy x-ray absorptiometry

  14. Waist Girth [ Time Frame: Change from baseline to 6 weeks ]
    Waist girth assessed by a measurement tape



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight or obese (BMI 25 or greater)

Exclusion Criteria:

  • Smokers
  • Diabetic
  • Taking medications that affect carbohydrate or lipid metabolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587051


Contacts
Layout table for location contacts
Contact: Philip Chilibeck, PhD 306-966-1072 phil.chilibeck@usask.ca

Locations
Layout table for location information
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 5B2
Contact: Philip D Chilibeck, Ph.D.    3069661072    phil.chilibeck@usask.ca   
Contact: Julianne Rooke, B.Sc.    3069661082    julianne.rooke@usask.ca   
Principal Investigator: Philip Chilibeck, Ph.D.         
Sub-Investigator: Gordon Zello, Ph.D.         
Sponsors and Collaborators
University of Saskatchewan
Heart and Stroke Foundation of Canada

Layout table for additonal information
Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03587051     History of Changes
Other Study ID Numbers: 17-171
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases