NCT02012855

Brief Summary

The increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for improving the blood lipid response to a subsequent meal; that is, the appearance of fat (triglyceride) in the blood is less after a meal if endurance exercise was performed shortly before (i.e. within half a day) of the meal (Petit et al. 2003). This benefit of exercise is unfortunately negated if the after-exercise food choice to replace the calories expended during exercise is one containing high glycemic index carbohydrates. For example, if a high glycemic index carbohydrate is consumed after an evening exercise session, the exercise no longer has an effect of lowering triglyceride in the blood after a meal consumed the next morning (Harrison et al. 2009; Burton et al. 2008). Very rarely do people perform an exercise session and then fast until their next meal hours later. The more common practice is to consume food immediately after the exercise to enhance recovery and because hunger is stimulated with exercise. Consuming carbohydrate with a low glycemic index has been shown to reduce the level of fat in the blood following a subsequent meal (Gruendel et al. 2007). To date, no studies have examined the effects of consuming a low-glycemic index meal after exercise on the blood fat response to a subsequent meal. The specific objective of our research is to determine the effect of consuming low glycemic index lentils after an endurance exercise session on the blood fat (triglyceride) response to a subsequent meal. Twenty-five overweight or obese men will have their blood triglycerides measured four times over six hours after a high-fat morning meal following four different conditions, in a randomized, counterbalanced, cross-over design (i.e. the 25 subjects will each participate in all four conditions, where the order of conditions for each person is randomized): 1) After exercise (90 minutes of moderate intensity walking) is performed the evening before, followed by caloric replacement with a high-glycemic index meal (i.e. white bread and instant mashed potatoes); 2) After the same exercise is performed the evening before, followed by caloric replacement with a lentil-based meal; 3) After the same exercise is performed the evening before, followed by fasting; 4) After a no exercise/ no meal condition (i.e. control condition). In addition to measuring blood triglycerides we will measure blood insulin, free fatty acid, high density lipoproteins, low density lipoproteins, and glucose levels as these are also related to cardiovascular disease risk and may be altered with exercise and lentil consumption. We will also measure the muscle's ability to burn fat (i.e. fat oxidation) by assessing respiratory gases (oxygen consumption and carbon dioxide output) after the high-fat meal because we expect exercise and lentils to increase fat oxidation. Our expected results are that consuming lentils after endurance exercise will lower the blood triglyceride response to a subsequent meal compared to exercise alone or when high-glycemic index carbohydrates are consumed after the exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

August 15, 2013

Last Update Submit

May 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in blood triglycerides

    Change from baseline at 6 hours

Secondary Outcomes (6)

  • Change in blood glucose

    Change from baseline at 6 hours

  • Change in fat oxidation

    Change from baseline at 6 hours

  • Change in low density lipoproteins

    Change from baseline at 6 hours

  • Change in high density lipoproteins

    Change from baseline at 6 hours

  • Change in total cholesterol

    Change from baseline at 6 hours

  • +1 more secondary outcomes

Study Arms (4)

Exercise only

EXPERIMENTAL

90 minutes of exercise

Behavioral: Exercise

Exercise and high glycemic index meal

EXPERIMENTAL

90 minutes of exercise followed by a high glycemic index meal matched for calories expended during the exercise

Behavioral: ExerciseOther: Diet (meal type)

Exercise and low glycemic index meal

EXPERIMENTAL

90 minutes of exercise followed by a low glycemic index meal matched for calories expended during the exercise

Behavioral: ExerciseOther: Diet (meal type)

No exercise and no meal

NO INTERVENTION

No exercise and no meal

Interventions

ExerciseBEHAVIORAL
Exercise and high glycemic index mealExercise and low glycemic index mealExercise only
Exercise and high glycemic index mealExercise and low glycemic index meal

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Philip D Chilibeck, Ph.D.

    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
Ph.D.

Study Record Dates

First Submitted

August 15, 2013

First Posted

December 16, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations