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Thermic Effect of Three Different Meals in Healthy Women

Primary Purpose

Weight Loss, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole Food Meal
Processed Food Meal
Gluten-free and lactose-free
Sponsored by
Skidmore College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy females between the ages of 18 and 24 years that have BMIs that fall in the range of 18.5 kg/m2 to 28 kg/m2.

Exclusion Criteria:

  • Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Whole Food Meal

    Processed Food Meal

    Gluten-Free and Lactose-Free Meal

    Arm Description

    Whole foods meal - grilled cheese and drink meal

    Highly processed foods - grilled cheese and drink meal

    Gluten-free and lactose-free foods - grilled cheese and drink meal

    Outcomes

    Primary Outcome Measures

    Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis
    The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)

    Secondary Outcome Measures

    Blood Glucose Response
    Change in postprandial blood glucose compared baseline
    Change in Hunger and Palatability Scores and Energy Level
    Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm
    Heart Rate
    Measure heart rate following the resting metabolic rate test
    Blood Pressure
    Measure blood pressure following the resting metabolic rate test

    Full Information

    First Posted
    June 11, 2020
    Last Updated
    June 17, 2020
    Sponsor
    Skidmore College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04440826
    Brief Title
    Thermic Effect of Three Different Meals in Healthy Women
    Official Title
    Dietary Induced Thermogenic Differences After Consumption of an Unrefined Meal, a Gluten-free Meal, and a Highly Processed Meal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 23, 2015 (Actual)
    Primary Completion Date
    May 30, 2015 (Actual)
    Study Completion Date
    May 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Skidmore College

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study will investigate the acute effect of three isocaloric meals varying in level of food processing, including a whole foods, gluten-free, and highly processed meal on energy metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.
    Detailed Description
    A shift towards a diet containing large quantities of highly processed foods is believed to be a major contributor to the trends in obesity. The degree of processing of foods often affects the nutritional content of the constituents. A reduction in macromolecular complexity allows for an increased rate of digestion, meaning that the body does not have to work as hard to metabolize high processed food products. Thus, the purpose of this study is to investigate the effect on energy metabolism and blood glucose after the consumption of an unrefined, whole foods meal versus two highly processed food meals, including a common Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals. It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic response and a smaller blood glucose response than a highly processed or gluten-free meal. Additionally, it is hypothesized that a highly processed foods meal will be considered more palatable than an unrefined or gluten-free meal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Whole Food Meal
    Arm Type
    Active Comparator
    Arm Description
    Whole foods meal - grilled cheese and drink meal
    Arm Title
    Processed Food Meal
    Arm Type
    Experimental
    Arm Description
    Highly processed foods - grilled cheese and drink meal
    Arm Title
    Gluten-Free and Lactose-Free Meal
    Arm Type
    Experimental
    Arm Description
    Gluten-free and lactose-free foods - grilled cheese and drink meal
    Intervention Type
    Other
    Intervention Name(s)
    Whole Food Meal
    Intervention Description
    Whole foods meal
    Intervention Type
    Other
    Intervention Name(s)
    Processed Food Meal
    Intervention Description
    Processed food meal
    Intervention Type
    Other
    Intervention Name(s)
    Gluten-free and lactose-free
    Intervention Description
    Gluten-free and lactose-free food meal
    Primary Outcome Measure Information:
    Title
    Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis
    Description
    The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)
    Time Frame
    TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
    Secondary Outcome Measure Information:
    Title
    Blood Glucose Response
    Description
    Change in postprandial blood glucose compared baseline
    Time Frame
    Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
    Title
    Change in Hunger and Palatability Scores and Energy Level
    Description
    Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm
    Time Frame
    Baseline 0 minutes, and 60, 120, 180 minutes postprandial
    Title
    Heart Rate
    Description
    Measure heart rate following the resting metabolic rate test
    Time Frame
    Baseline 0 minutes
    Title
    Blood Pressure
    Description
    Measure blood pressure following the resting metabolic rate test
    Time Frame
    Baseline 0 minutes

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy females between the ages of 18 and 24 years that have BMIs that fall in the range of 18.5 kg/m2 to 28 kg/m2. Exclusion Criteria: Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Hoehn, MPH
    Organizational Affiliation
    Skidmore College
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Thermic Effect of Three Different Meals in Healthy Women

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