search
Back to results

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
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring glucose tolerance, meal timing, insulin, postprandial, walking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 9, 2021
    Last Updated
    July 9, 2021
    Sponsor
    Monash University
    search

    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

    We'll reach out to this number within 24 hrs