Night Time Walking to Improve Glycaemic Control in Healthy Adults

Study Overview
=================
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.

Official Title
-----------------
The Effect of Exercise Timing on Postprandial Glycaemic Control: A Randomised Crossover Trial in Healthy Adults

Conditions
-----------------
Postprandial Hyperglycemia, Insulin Resistance

Intervention / Treatment
-----------------
* Other: Early exercise
* Other: Late exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Early exercise<br>Participants will exercise for 30 minutes prior to an evening meal | Other: Early exercise<br>* Participants will exercise for 30 minutes prior to an evening meal.<br>|
| Experimental: Late exercise<br>Participants will exercise for 30 minutes after an evening meal | Other: Late exercise<br>* Participants will exercise for 30 minutes after an evening meal.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose | Change in glucose incremental area under the curve (iAUC) in response to a meal challenge | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial insulin | Change in insulin incremental area under the curve (iAUC) in response to a meal challenge | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose tolerance, meal timing, insulin, postprandial, walking