Night Time Walking to Improve Glycaemic Control in Healthy Adults
Primary Purpose
Postprandial Hyperglycemia, Insulin Resistance
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early exercise
Late exercise
Sponsored by
About this trial
This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring glucose tolerance, meal timing, insulin, postprandial, walking
Eligibility Criteria
Inclusion criteria
- Men and Women aged 18 to 65 years of age
- Waist circumference of <94cm and <80cm for Caucasian males and females, respectively
- Waist circumference of <90cm and <80 cm for Asian males and females, respectively
- Willingness to provide written informed consent and willingness to participate and comply with the study
Exclusion criteria
- Current or recent treatment (within 6 months) with medications that influence blood glucose
- Fasting blood glucose ≥ 7 mmol/L
- Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
- Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
- Not able to walk for 30 mins at 5-5.5 km/hr
- Women planning pregnancy, pregnant or lactating.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Early exercise
Late exercise
Arm Description
Participants will exercise for 30 minutes prior to an evening meal
Participants will exercise for 30 minutes after an evening meal
Outcomes
Primary Outcome Measures
Postprandial glucose
Change in glucose incremental area under the curve (iAUC) in response to a meal challenge
Secondary Outcome Measures
Postprandial insulin
Change in insulin incremental area under the curve (iAUC) in response to a meal challenge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04958317
Brief Title
Night Time Walking to Improve Glycaemic Control in Healthy Adults
Official Title
The Effect of Exercise Timing on Postprandial Glycaemic Control: A Randomised Crossover Trial in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.
Detailed Description
In this crossover trial, eligible participants will be randomised to a 30-minute bout of physical activity (30 minute walk) either during the day or after an evening meal. The postprandial response to the evening meal will be analysed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia, Insulin Resistance
Keywords
glucose tolerance, meal timing, insulin, postprandial, walking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
This is a single masking study.
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early exercise
Arm Type
Placebo Comparator
Arm Description
Participants will exercise for 30 minutes prior to an evening meal
Arm Title
Late exercise
Arm Type
Experimental
Arm Description
Participants will exercise for 30 minutes after an evening meal
Intervention Type
Other
Intervention Name(s)
Early exercise
Intervention Description
Participants will exercise for 30 minutes prior to an evening meal.
Intervention Type
Other
Intervention Name(s)
Late exercise
Intervention Description
Participants will exercise for 30 minutes after an evening meal.
Primary Outcome Measure Information:
Title
Postprandial glucose
Description
Change in glucose incremental area under the curve (iAUC) in response to a meal challenge
Time Frame
Three hour glucose iAUC will be calculated at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.
Secondary Outcome Measure Information:
Title
Postprandial insulin
Description
Change in insulin incremental area under the curve (iAUC) in response to a meal challenge
Time Frame
Three hour insulin iAUC will be calculated at six time points (0, 30, 60, 90, 120 and 180 mins) after beginning consumption of the test meal.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
Men and Women aged 18 to 65 years of age
Waist circumference of <94cm and <80cm for Caucasian males and females, respectively
Waist circumference of <90cm and <80 cm for Asian males and females, respectively
Willingness to provide written informed consent and willingness to participate and comply with the study
Exclusion criteria
Current or recent treatment (within 6 months) with medications that influence blood glucose
Fasting blood glucose ≥ 7 mmol/L
Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
Not able to walk for 30 mins at 5-5.5 km/hr
Women planning pregnancy, pregnant or lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxine Bonham, PhD
Phone
+61418234292
Email
maxine.bonham@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Cardoso, PhD
Phone
+6139902 4264
Email
barbara.cardoso@monash.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Night Time Walking to Improve Glycaemic Control in Healthy Adults
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