<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977260</url>
  </required_header>
  <id_info>
    <org_study_id>2015/00867 Part 1</org_study_id>
    <nct_id>NCT02977260</nct_id>
  </id_info>
  <brief_title>The Lunch Study: the Combined Effects of Food Texture and Energy Density on Intake</brief_title>
  <official_title>The Lunch Study: the Combined Effects of Food Texture and Energy Density on Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Nutrition Research Centre, Singapore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Meal size is strongly influenced by a number of external features of the food environment&#xD;
      which can promote over-consumption, such as the availability of palatable energy dense foods.&#xD;
      The current research aimed to investigate whether natural food-based differences in texture&#xD;
      could be used to slow down eating rate and reduce intake from large portions and higher&#xD;
      energy dense foods.&#xD;
&#xD;
      A four-session randomised crossover study assessed the effect of faster vs. slower eating&#xD;
      rate, achieved through manipulating food texture, on ad-libitum consumption (weight and&#xD;
      calories) at a meal, alone and in combination with variations in meal energy-density (higher&#xD;
      vs. lower)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current obesogenic environment is characterized by the abundance of palatable and high&#xD;
      energy dense foods. High dietary energy density can promote sustained overcompensation at&#xD;
      meal times. On the other hand, eating at a slower rate has been shown to reduce meal size,&#xD;
      and food-based texture differences can slow eating rate. It is possible that texture-based&#xD;
      differences in eating rate could be used to reduce energy intake in of foods that are higher&#xD;
      in energy density.&#xD;
&#xD;
      This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum&#xD;
      consumption of a meal, alone and in combination with variations in meal energy-density (0.57&#xD;
      kcal/g vs 1.01 kcal/g). The meal combinations were as follows:&#xD;
&#xD;
      Meal 1: thin/0.57 kcal; Meal 2: thin/1.01 kcal/g; Meal 3: thick/ 0.57 kcal/g; Meal 4: thick&#xD;
      /1.01 kcal/g&#xD;
&#xD;
      Participants consumed the four test meals over four non-consecutive test sessions at the&#xD;
      Clinical Nutrition Research Centre, with at least three days washout between each session.&#xD;
      Each part followed a completely randomised full crossover design.&#xD;
&#xD;
      The primary objective was to assess ad libitum intake (both kcal and g) of the test meals,&#xD;
      depending on the combination of food texture and energy density.&#xD;
&#xD;
      The secondary objectives were to assess the eating rate, oral processing characteristics,&#xD;
      changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the&#xD;
      rest of the test day (food diary), as a function of the test meal texture and energy density&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ad libitum intake of the test meals - weight (g)</measure>
    <time_frame>Measured once for up to 20 minutes</time_frame>
    <description>The weight of the test meal consumed during the test session was measured.&#xD;
There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ad libitum intake of the test meals - calories (kcal)</measure>
    <time_frame>Measured once for up to 20 minutes</time_frame>
    <description>The weight of the meal consumed was measured and convert to calories using the meal energy density (which is known).&#xD;
There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating rate of the test meals</measure>
    <time_frame>Measured once for up to 20 minutes</time_frame>
    <description>Video recordings of the participants eating are coded and from this eating rate was calculated as grams consumed per minute (g/min).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in rated appetite pre- to post meal consumption and up to 90 minutes post-consumption</measure>
    <time_frame>pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes</time_frame>
    <description>100-point Visual Analogue Scale (VAS) ratings of hunger, fullness, desire to eat, prospective consumption and thirst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake (kcal) for the rest of the test day recorded in a Food diary</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Food intake recorded in a food diary</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Satiation</condition>
  <arm_group>
    <arm_group_label>Test Meal 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thin/Low Energy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Meal 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thin/High Energy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Meal 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thick/Low Energy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Meal 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thick/High Energy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thin/Low Energy</intervention_name>
    <description>Thin textured rice meal (ground rice grains) with lower energy density (0.57 kcal/g)</description>
    <arm_group_label>Test Meal 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thin/High Energy</intervention_name>
    <description>Thin textured rice meal (ground rice grains) with higher energy density (1.01 kcal/g)</description>
    <arm_group_label>Test Meal 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thick/Low Energy</intervention_name>
    <description>Thicker textured rice meal (whole rice grains) with lower energy density (0.57 kcal/g)</description>
    <arm_group_label>Test Meal 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thick/High Energy</intervention_name>
    <description>Thicker textured rice meal (whole rice grains) and high energy density (1.01 kcal/g)</description>
    <arm_group_label>Test Meal 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Aged between 21 and 50 years&#xD;
&#xD;
          -  BMI &lt; 30 kg/m2&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Individuals whose body weight has changed more than 5 kilograms in the last 12 months&#xD;
&#xD;
          -  People who are taking insulin or medications known to affect glucose metabolism,&#xD;
             appetite or energy metabolism&#xD;
&#xD;
          -  Individuals who are currently dieting&#xD;
&#xD;
          -  People with intolerances or allergies to study foods or test products, e.g. soya,&#xD;
             wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat,&#xD;
             seafood, sugar and sweetener, gelatin, natural food colourings or flavourings, etc&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keri McCrickerd, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Nutrition Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition Research Centre</name>
      <address>
        <city>Singapore</city>
        <zip>117599</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Nutrition Research Centre, Singapore</investigator_affiliation>
    <investigator_full_name>Keri McCrickerd</investigator_full_name>
    <investigator_title>Dr Keri McCrickerd</investigator_title>
  </responsible_party>
  <keyword>Meal size</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977260
org study id: 2015/00867 Part 1
nct id: NCT02977260
lead sponsor: 
has dmc: Yes
Meal size is strongly influenced by a number of external features of the food environment
      which can promote over-consumption, such as the availability of palatable energy dense foods.
      The current research aimed to investigate whether natural food-based differences in texture
      could be used to slow down eating rate and reduce intake from large portions and higher
      energy dense foods.

      A four-session randomised crossover study assessed the effect of faster vs. slower eating
      rate, achieved through manipulating food texture, on ad-libitum consumption (weight and
      calories) at a meal, alone and in combination with variations in meal energy-density (higher
      vs. lower)
The current obesogenic environment is characterized by the abundance of palatable and high
      energy dense foods. High dietary energy density can promote sustained overcompensation at
      meal times. On the other hand, eating at a slower rate has been shown to reduce meal size,
      and food-based texture differences can slow eating rate. It is possible that texture-based
      differences in eating rate could be used to reduce energy intake in of foods that are higher
      in energy density.

      This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum
      consumption of a meal, alone and in combination with variations in meal energy-density (0.57
      kcal/g vs 1.01 kcal/g). The meal combinations were as follows:

      Meal 1: thin/0.57 kcal; Meal 2: thin/1.01 kcal/g; Meal 3: thick/ 0.57 kcal/g; Meal 4: thick
      /1.01 kcal/g

      Participants consumed the four test meals over four non-consecutive test sessions at the
      Clinical Nutrition Research Centre, with at least three days washout between each session.
      Each part followed a completely randomised full crossover design.

      The primary objective was to assess ad libitum intake (both kcal and g) of the test meals,
      depending on the combination of food texture and energy density.

      The secondary objectives were to assess the eating rate, oral processing characteristics,
      changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the
      rest of the test day (food diary), as a function of the test meal texture and energy density
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Ad libitum intake of the test meals - weight (g)
time frame: Measured once for up to 20 minutes
description: The weight of the test meal consumed during the test session was measured.
There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.
measure: Ad libitum intake of the test meals - calories (kcal)
time frame: Measured once for up to 20 minutes
description: The weight of the meal consumed was measured and convert to calories using the meal energy density (which is known).
There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time.
measure: Eating rate of the test meals
time frame: Measured once for up to 20 minutes
description: Video recordings of the participants eating are coded and from this eating rate was calculated as grams consumed per minute (g/min).
measure: Changes in rated appetite pre- to post meal consumption and up to 90 minutes post-consumption
time frame: pre-meal, immediately post-meal, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, + 90 minutes
description: 100-point Visual Analogue Scale (VAS) ratings of hunger, fullness, desire to eat, prospective consumption and thirst
measure: Energy intake (kcal) for the rest of the test day recorded in a Food diary
time frame: Up to 24 hours
description: Food intake recorded in a food diary
arm group label: Test Meal 1
arm group type: Experimental
description: Thin/Low Energy
arm group label: Test Meal 2
arm group type: Experimental
description: Thin/High Energy
arm group label: Test Meal 3
arm group type: Experimental
description: Thick/Low Energy
arm group label: Test Meal 4
arm group type: Experimental
description: Thick/High Energy
intervention type: Other
intervention name: Thin/Low Energy
description: Thin textured rice meal (ground rice grains) with lower energy density (0.57 kcal/g)
arm group label: Test Meal 1
intervention type: Other
intervention name: Thin/High Energy
description: Thin textured rice meal (ground rice grains) with higher energy density (1.01 kcal/g)
arm group label: Test Meal 2
intervention type: Other
intervention name: Thick/Low Energy
description: Thicker textured rice meal (whole rice grains) with lower energy density (0.57 kcal/g)
arm group label: Test Meal 3
intervention type: Other
intervention name: Thick/High Energy
description: Thicker textured rice meal (whole rice grains) and high energy density (1.01 kcal/g)
arm group label: Test Meal 4
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keri McCrickerd, PhD
role: Principal Investigator
affiliation: Clinical Nutrition Research Centre
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Clinical Nutrition Research Centre, Singapore
investigator full name: Keri McCrickerd
investigator title: Dr Keri McCrickerd
sharing ipd: No