NCT03154216

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

May 20, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

May 12, 2017

Last Update Submit

May 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in blood triglycerides

    Triglyceride levels after a high-fat breakfast

    Change from baseline to 6 hours

Secondary Outcomes (7)

  • Change in blood glucose

    Change from baseline to 6 hours

  • Change in fat oxidation

    Change from baseline to 6 hours

  • Change in low density lipoproteins

    Change from baseline to 6 hours

  • Change in high density lipoproteins

    Change from baseline to 6 hours

  • Change in total cholesterol

    Change from baseline to 6 hours

  • +2 more secondary outcomes

Study Arms (4)

Exercise only

EXPERIMENTAL

90 minutes of exercise

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

Behavioral: ExerciseOther: 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

Behavioral: ExerciseOther: Drink

No exercise and no beverage

NO INTERVENTION

No exercise and no beverage

Interventions

ExerciseBEHAVIORAL

90 minutes of moderate-intensity walking exercise on a treadmill

Exercise and high glycemic index drinkExercise and low glycemic index drinkExercise only
DrinkOTHER

Beverage to be consumed after exercise

Exercise and high glycemic index drinkExercise and low glycemic index drink

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index of 25 or greater
  • years of age

You may not qualify if:

  • diabetics
  • smokers
  • those taking medications for cholesterol or glucose
  • those who are allergic to milk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan (SK), S7N5B2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 27376698BACKGROUND
  • Gao 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.

MeSH Terms

Conditions

Hyperlipoproteinemia Type IV

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemia

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 16, 2017

Study Start

May 20, 2017

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations