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Mealtime Walking Study to Improve Postprandial Metabolic Response

Primary Purpose

PreDiabetes, Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
15-minute walk at preferred walking speed.
Fiber
control
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PreDiabetes focused on measuring blood glucose, blood insulin, fiber, prediabetes, postprandial glycemia

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • obese (BMI ≥ 30 kg/m2)
  • nonsmoking
  • sedentary
  • fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L

Exclusion Criteria:

  • answered "yes" to any of the questions on the "Par-Q & You" questionnaire
  • refused to discontinue antioxidant supplement use for several weeks prior to and during the study
  • prescribed medication use (unless use was consistent for the 3 months prior to the study and intake remained consistent throughout the study duration)
  • food allergies or medical conditions that impacted normal functioning of the gastrointestinal tract

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    Control

    Fiber

    Walk

    Arm Description

    Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) added to the apple juice (active) and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption . One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption

    Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. 9 grams of soluble viscous fiber from psyllium husk (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) was mixed with the apple juice. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption. One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo).

    Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes. Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo comparator). One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) added to the apple juice and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (active comparator).

    Outcomes

    Primary Outcome Measures

    Postprandial glycemia
    incremental area under curve
    postprandial insulinemia
    incremental area under curve

    Secondary Outcome Measures

    postprandial oxidative stress
    total antioxidant capacity of blood
    postprandial oxidative stress
    blood interleukin-6
    postprandial oxidative stress
    Thiobarbituric Acid Reactive Substances TBARS

    Full Information

    First Posted
    July 31, 2020
    Last Updated
    July 19, 2021
    Sponsor
    Arizona State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04499287
    Brief Title
    Mealtime Walking Study to Improve Postprandial Metabolic Response
    Official Title
    Mealtime Walking Study to Improve Postprandial Metabolic Response
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 17, 2014 (Actual)
    Primary Completion Date
    February 14, 2015 (Actual)
    Study Completion Date
    March 10, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arizona State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized crossover trial will investigate the metabolic responses following the consumption of a bagel+juice meal under 3 conditions: control, fiber (positive control), and postmeal walk in15 healthy adults. It is hypothesized that the postmeal walk will reduce glycemia, insulinemia, and oxidative stress similar to fiber.
    Detailed Description
    The study will follow a randomized, crossover design. Participants and the investigator will be blinded for the control treatments but not for the walk treatment. Participants will complete 3 meal tests; tests are separated by about 1 week. An initial screening visit will be scheduled for the online survey respondents that meet the inclusion criteria and are willing to consider participation. At this visit, written consent will be secured followed by further screening for the exclusion criteria and the collection of demographic and health history data and anthropometric measures. A fasting blood sample will be collected for glucose analysis. Participants will be scheduled for experimental testing and provided with instructions and calendars. Participants will be given at least one week's notice if they do not qualify for the trial based on fasting glucose concentrations. On the day prior to each experimental day, the participants will consume 2 bagels (54 g carbohydrate/bagel), and on the night prior to each visit, participants will consume a standard dinner of their choice. (The bagels will be provided to participants and the standardized dinner will be documented. The bagels and standardized dinner meal will facilitate controlled 'glycogen loading' prior to testing.) No other food will be consumed after this dinner meal, and participants will fast overnight until they arrive at the research center the next morning (e.g., no food or beverage with the exception of water). Fasting blood (1 tablespoon) will be collected and the test meal (bagel+juice) will be consumed. Postprandial blood samples will be collected for 4 hours (see below). The subjects will not be allowed to consume any food or beverage (with the exception of water) through the duration the visit. A snack will be provided to participants once the testing is over. Glucose: 0,15,30,60,120, 180, 240 Insulin: 0, 30, 120, 180, 240 Oxidative Stress Markers: 0, 180, 240 The blood insulin level will be determined in venous blood by RIA. Capillary blood glucose will be determined with a glucometer. Oxidative stress, e.g., total antioxidant capacity, IL-6, and TBARS will be assessed using microplate analyses kits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PreDiabetes, Postprandial Hyperglycemia
    Keywords
    blood glucose, blood insulin, fiber, prediabetes, postprandial glycemia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    randomized, controlled, crossover
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) added to the apple juice (active) and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption . One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption
    Arm Title
    Fiber
    Arm Type
    Active Comparator
    Arm Description
    Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. 9 grams of soluble viscous fiber from psyllium husk (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) was mixed with the apple juice. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption. One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo).
    Arm Title
    Walk
    Arm Type
    Experimental
    Arm Description
    Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes. Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo comparator). One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) added to the apple juice and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (active comparator).
    Intervention Type
    Other
    Intervention Name(s)
    15-minute walk at preferred walking speed.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fiber
    Intervention Description
    9 grams soluble fiber
    Intervention Type
    Other
    Intervention Name(s)
    control
    Intervention Description
    control
    Primary Outcome Measure Information:
    Title
    Postprandial glycemia
    Description
    incremental area under curve
    Time Frame
    4 hours
    Title
    postprandial insulinemia
    Description
    incremental area under curve
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    postprandial oxidative stress
    Description
    total antioxidant capacity of blood
    Time Frame
    4 hours
    Title
    postprandial oxidative stress
    Description
    blood interleukin-6
    Time Frame
    4 hours
    Title
    postprandial oxidative stress
    Description
    Thiobarbituric Acid Reactive Substances TBARS
    Time Frame
    4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: obese (BMI ≥ 30 kg/m2) nonsmoking sedentary fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L Exclusion Criteria: answered "yes" to any of the questions on the "Par-Q & You" questionnaire refused to discontinue antioxidant supplement use for several weeks prior to and during the study prescribed medication use (unless use was consistent for the 3 months prior to the study and intake remained consistent throughout the study duration) food allergies or medical conditions that impacted normal functioning of the gastrointestinal tract

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mealtime Walking Study to Improve Postprandial Metabolic Response

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