NCT03587051

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

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

June 27, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 27, 2018

Last Update Submit

June 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postprandial triglycerides

    Triglyceride from serum

    Change from baseline to 1 week and 6 weeks

Secondary Outcomes (14)

  • Postprandial cholesterol

    Change from baseline to 1 week and 6 weeks

  • Postprandial low density lipoprotein

    Change from baseline to 1 week and 6 weeks

  • Postprandial high density lipoprotein

    Change from baseline to 1 week and 6 weeks

  • Postprandial glucose

    Change from baseline to 1 week and 6 weeks

  • Postprandial insulin

    Change from baseline to 1 week and 6 weeks

  • +9 more secondary outcomes

Study Arms (2)

Low glycemic index post-exercise diet

EXPERIMENTAL

Lentil-based post-exercise meal

Dietary Supplement: Low glycemic index post-exercise diet

High glycemic index post-exercise diet

ACTIVE COMPARATOR

Instant potato, white bread, and egg white post-exercise meal

Dietary Supplement: High glycemic index post-exercise diet

Interventions

Feeding of a low-glycemic index, lentil meal after 90 minutes of walking exercise

Low 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

High glycemic index post-exercise diet

Eligibility Criteria

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

You may qualify if:

  • Overweight or obese (BMI 25 or greater)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 16, 2018

Study Start

July 15, 2018

Primary Completion

September 30, 2019

Study Completion

December 30, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations