Night Time Walking to Improve Glycaemic Control in Healthy Adults

July 9, 2021 updated by: Barbara R. Cardoso, Monash University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucose
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Night Glucose response-walk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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