Night Time Walking to Improve Glycaemic Control in Healthy Adults

Sponsor

Monash University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04958317

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.

Condition or Disease	Intervention/Treatment	Phase
Postprandial Hyperglycemia Insulin Resistance	Other: Early exercise Other: Late exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Masking Description:

This is a single masking study.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Early exercise Participants will exercise for 30 minutes prior to an evening meal	Other: Early exercise Participants will exercise for 30 minutes prior to an evening meal.
Experimental: Late exercise Participants will exercise for 30 minutes after an evening meal	Other: Late exercise Participants will exercise for 30 minutes after an evening meal.

Arm

Intervention/Treatment

Placebo Comparator: Early exercise

Participants will exercise for 30 minutes prior to an evening meal

Other: Early exercise

Participants will exercise for 30 minutes prior to an evening meal.

Experimental: Late exercise

Participants will exercise for 30 minutes after an evening meal

Other: Late exercise

Participants will exercise for 30 minutes after an evening meal.

Outcome Measures

Primary Outcome Measures

Postprandial glucose [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.]
Change in glucose incremental area under the curve (iAUC) in response to a meal challenge

Secondary Outcome Measures

Postprandial insulin [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.]
Change in insulin incremental area under the curve (iAUC) in response to a meal challenge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.