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Sugar-sweetened Beverages Influence Benefits of Exercise in Overweight Adults

Primary Purpose

Inflammation, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise with and without SSB ingestion
Sponsored by
Montana State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring metabolic syndrome, inflammation, insulin sensitivity, metabolic flexibility, overweight/obese

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI > 25 and < 35 kg/m2
  • sedentary to moderately active

Exclusion Criteria:

  • inflammatory conditions
  • heart disease, diabetes, and other diseases that may interfere with the safety of exercise or other experimental procedures
  • allergy to wheat, gluten, dairy, or peanuts
  • taking blood pressure, cholesterol lowering, or anti-inflammatory medications
  • taking hormone-based birth control with exception of intrauterine device,
  • pregnant
  • health concerns that make it difficult to participate in study procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    EX+H2O

    EX+SSB

    CONTROL

    Arm Description

    Exercise and diet that did not include SSB

    Exercise and diet that includes SSB

    No exercise and diet that did not include SSB

    Outcomes

    Primary Outcome Measures

    Glucose tolerance
    75 g oral glucose tolerance test with measurement of glucose and insulin
    Metabolic flexibility
    Change in respiratory exchange ratio in response to ingestion of 75 g of glucose
    Inflammation
    Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2018
    Last Updated
    June 26, 2018
    Sponsor
    Montana State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03576703
    Brief Title
    Sugar-sweetened Beverages Influence Benefits of Exercise in Overweight Adults
    Official Title
    The Influence of Diet During and After Exercise on Metabolic Benefits of Exercise in Overweight Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 24, 2014 (Actual)
    Primary Completion Date
    July 9, 2015 (Actual)
    Study Completion Date
    July 9, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Montana 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
    The objective of this study was to determine how metabolic and inflammatory effects of physical exercise in overweight individuals are altered when sugar-sweetened beverages (SSB) are consumed after physical exercise. A randomized, controlled crossover trial was performed in which participants performed exercise with and without the ingestions of SSB during exercise or a non-exercise control condition to evaluate metabolic and inflammatory responses one day after the exercise and or SSB treatment.
    Detailed Description
    Participants: Women (n=24; 18-55 y) with a BMI > 25 and < 35 kg·m-2 who are sedentary to moderately active were recruited to participate. Research Design: This study was a randomized, counter-balanced, cross-over clinical trial consisting of three experimental conditions in which each participant served as her/his own control. Assessments of health history, physical activity (to confirm that participants were physically inactive), anthropometrics, resting metabolic rate, and aerobic capacity were made during an initial laboratory visit. Participants performed three different study conditions, typically separated by one week, thus women were not tested in a specific menstrual cycle phase. Participants recorded their diet the day before and the morning of the first condition and replicated this for the second and third conditions. On the study days, participants consumed their breakfast prior to 9:00 AM and arrived in the lab at 11 AM. The three conditions were performed in randomized order. In the control condition (CON), participants rested quietly for 1 hour. In the remaining two conditions, participants performed 45 minutes of treadmill exercise at 11 AM. Following the rest or exercise period, subjects were provided energy balanced diets. Total energy intake was balanced across exercise conditions and appropriately adjusted for the lack of exercise in the CON condition. At 7 AM on the following morning, following an overnight fast, an oral glucose tolerance test (OGTT) was performed. Measurements were made to determine fasting glucose, insulin and lipid panel, 2-hour OGTT glucose, insulin sensitivity (SI OGTT), early (0-30 min) and late (30-120 min) glucose stimulated insulin secretion (GSIS) based on c-peptide concentrations. Indirect calorimetry was also performed to determine resting carbohydrate and fat oxidation and metabolic flexibility, defined as the change in respiratory exchange ration (RER) during the OGTT. Interleukin-6, tumor necrosis factor-alpha, and reactive oxygen species were measure before, 60, and 120 minutes during the OGTT to assess the inflammation response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation, Insulin Sensitivity
    Keywords
    metabolic syndrome, inflammation, insulin sensitivity, metabolic flexibility, overweight/obese

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    randomized crossover
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EX+H2O
    Arm Type
    Experimental
    Arm Description
    Exercise and diet that did not include SSB
    Arm Title
    EX+SSB
    Arm Type
    Experimental
    Arm Description
    Exercise and diet that includes SSB
    Arm Title
    CONTROL
    Arm Type
    No Intervention
    Arm Description
    No exercise and diet that did not include SSB
    Intervention Type
    Other
    Intervention Name(s)
    Exercise with and without SSB ingestion
    Intervention Description
    Consumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control
    Primary Outcome Measure Information:
    Title
    Glucose tolerance
    Description
    75 g oral glucose tolerance test with measurement of glucose and insulin
    Time Frame
    2 hours
    Title
    Metabolic flexibility
    Description
    Change in respiratory exchange ratio in response to ingestion of 75 g of glucose
    Time Frame
    2 hours
    Title
    Inflammation
    Description
    Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI > 25 and < 35 kg/m2 sedentary to moderately active Exclusion Criteria: inflammatory conditions heart disease, diabetes, and other diseases that may interfere with the safety of exercise or other experimental procedures allergy to wheat, gluten, dairy, or peanuts taking blood pressure, cholesterol lowering, or anti-inflammatory medications taking hormone-based birth control with exception of intrauterine device, pregnant health concerns that make it difficult to participate in study procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary P Miles, PhD
    Organizational Affiliation
    Montana State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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