<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/NCT03816579</url>
  </required_header>
  <id_info>
    <org_study_id>18-0147</org_study_id>
    <nct_id>NCT03816579</nct_id>
  </id_info>
  <brief_title>A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism</brief_title>
  <acronym>MAPP</acronym>
  <official_title>A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To highlight the importance of protein quality rather than the total protein content of a&#xD;
      meal, the investigators will demonstrate that unlike high quality proteins, a single meal&#xD;
      containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein&#xD;
      synthesis. Secondly, the investigators will directly challenge a prevalent, but untested,&#xD;
      assertion that has the potential to negatively impact health. The goal is to demonstrate that&#xD;
      complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed&#xD;
      at the same meal to stimulate protein synthesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will test the following hypotheses in middle-aged men and women (45-60)&#xD;
      years old using a randomized, cross over design. All study objectives will be met&#xD;
      concurrently:&#xD;
&#xD;
        1. Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate&#xD;
           acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis&#xD;
           [confirmatory hypothesis]&#xD;
&#xD;
        2. Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential&#xD;
           amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein&#xD;
           synthesis, but to a lesser extent than beef-protein.&#xD;
&#xD;
        3. A single meal containing 30 g of an incomplete plant-based protein source (PRO-C:&#xD;
           lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein&#xD;
           synthesis&#xD;
&#xD;
        4. Meals containing 30 g of plant-based protein that are incomplete at each separate meal,&#xD;
           but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle&#xD;
           protein synthesis.&#xD;
&#xD;
        5. Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose&#xD;
           [descriptive]&#xD;
&#xD;
      If these hypotheses are correct, the investigators will demonstrate that meals containing a&#xD;
      moderate amount of high quality protein, such as beef, are an efficient and effective way to&#xD;
      augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a&#xD;
      prerequisite for outcomes related to physical function, performance, successful aging and&#xD;
      metabolic health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">January 21, 2021</completion_date>
  <primary_completion_date type="Actual">January 21, 2021</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute muscle protein synthesis: PRO-A</measure>
    <time_frame>3 hours after consuming meal</time_frame>
    <description>Muscle protein synthesis response to PRO-A breakfast meal (%/h)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute muscle protein synthesis: PRO-B</measure>
    <time_frame>3 hours after consuming meal</time_frame>
    <description>Muscle protein synthesis response to PRO-B breakfast meal (%/h)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute muscle protein synthesis: PRO-C</measure>
    <time_frame>3 hours after consuming meal</time_frame>
    <description>Muscle protein synthesis response to PRO-C breakfast meal (%/h)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute muscle protein synthesis: CON</measure>
    <time_frame>3 hours after consuming meal</time_frame>
    <description>Muscle protein synthesis response to CON breakfast meal (%/hour)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour muscle protein synthesis: PRO-A</measure>
    <time_frame>Approximately 24 hours</time_frame>
    <description>Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour muscle protein synthesis: PRO-B</measure>
    <time_frame>Approximately 24 hours</time_frame>
    <description>Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour muscle protein synthesis: PRO-C</measure>
    <time_frame>Approximately 24 hours</time_frame>
    <description>Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood amino acid response to diet: PRO-A</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood amino acid response to diet: PRO-B</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood amino acid response to diet: PRO-C</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood amino acid response to diet: CON</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood glucose response to diet: PRO-A</measure>
    <time_frame>Approximately 24 hours</time_frame>
    <description>Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose response to diet: PRO-B</measure>
    <time_frame>Approximately 24 hours</time_frame>
    <description>Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose response to diet: PRO-C</measure>
    <time_frame>Approximately 24 hours</time_frame>
    <description>Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose response to diet: CON</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite and Hedonic Questionnaire: PRO-A</measure>
    <time_frame>Approximately 8 hours</time_frame>
    <description>Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-A diet. All outcomes are scored individually on a 10 pt visual analog scale using &quot;not at all&quot; being 0 and &quot;extremely&quot; being a 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite and Hedonic Questionnaire: PRO-B</measure>
    <time_frame>Approximately 8 hours</time_frame>
    <description>Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-B diet. All outcomes are scored individually on a 10 pt visual analog scale using &quot;not at all&quot; being 0 and &quot;extremely&quot; being a 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite and Hedonic Questionnaire: PRO-C</measure>
    <time_frame>Approximately 8 hours</time_frame>
    <description>Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-C diet. All outcomes are scored individually on a 10 pt visual analog scale using &quot;not at all&quot; being 0 and &quot;extremely&quot; being a 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite and Hedonic Questionnaire: CON</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to CON diet. All outcomes are scored individually on a 10 pt visual analog scale using &quot;not at all&quot; being 0 and &quot;extremely&quot; being a 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 day dietary record: PRO-A</measure>
    <time_frame>Approximately 36 hours</time_frame>
    <description>Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 day dietary record: PRO-B</measure>
    <time_frame>Approximately 36 hours</time_frame>
    <description>Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 day dietary record: PRO-C</measure>
    <time_frame>Approximately 36 hours</time_frame>
    <description>Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 day dietary record: CON</measure>
    <time_frame>Approximately 36 hours</time_frame>
    <description>Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability Questionnaire:PRO-A</measure>
    <time_frame>Approximately 8 hours</time_frame>
    <description>Questionnaires will be given to assess palatability of the PRO-A diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being &quot;extremely dislike&quot;, 5 being &quot;neither like nor dislike&quot; and 10 being &quot;extremely like&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability Questionnaire:PRO-B</measure>
    <time_frame>Approximately 8 hours</time_frame>
    <description>Questionnaires will be given to assess palatability of the PRO-B diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being &quot;extremely dislike&quot;, 5 being &quot;neither like nor dislike&quot; and 10 being &quot;extremely like&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability Questionnaire:PRO-C</measure>
    <time_frame>Approximately 8 hours</time_frame>
    <description>Questionnaires will be given to assess palatability of the PRO-C diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being &quot;extremely dislike&quot;, 5 being &quot;neither like nor dislike&quot; and 10 being &quot;extremely like&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability Questionnaire:CON</measure>
    <time_frame>Approximately 5 hours</time_frame>
    <description>Questionnaires will be given to assess palatability of the CON diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being &quot;extremely dislike&quot;, 5 being &quot;neither like nor dislike&quot; and 10 being &quot;extremely like&quot;.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Protein</condition>
  <condition>Diet</condition>
  <condition>Skeletal Muscle</condition>
  <arm_group>
    <arm_group_label>PRO-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beef protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRO-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Complementary proteins at each meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRO-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Complementary proteins over 24 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CON</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Low protein (&lt;5 g) meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRO-A</intervention_name>
    <description>30 g of beef protein will be consumed at each meal</description>
    <arm_group_label>PRO-A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRO-B</intervention_name>
    <description>30 g of complementary proteins will be consumed at each meal</description>
    <arm_group_label>PRO-B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRO-C</intervention_name>
    <description>30 g of complementary proteins will be consumed over 24 hours</description>
    <arm_group_label>PRO-C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All races and ethnic backgrounds&#xD;
&#xD;
          2. Men and women, age 45-60 years&#xD;
&#xD;
          3. Generally healthy (see exclusion criteria)&#xD;
&#xD;
          4. Able and willing to provide informed consent&#xD;
&#xD;
          5. Ability to speak and read English (* the study procedures, e.g., muscle biopsy,&#xD;
             duration of each acute study, e.g. overnight stay; and multiple dietary questionnaires&#xD;
             require sound written and spoken English)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP&#xD;
             (44))&#xD;
&#xD;
          2. Clinically significant heart disease (e.g. New York Heart Classification greater than&#xD;
             grade II; ischemia)&#xD;
&#xD;
          3. Peripheral vascular disease&#xD;
&#xD;
          4. Pulmonary disease&#xD;
&#xD;
          5. History of systemic or pulmonary embolus&#xD;
&#xD;
          6. Uncontrolled blood pressure (systolic BP&gt;170, diastolic BP&gt;95 mmHg)&#xD;
&#xD;
          7. Impaired renal function (creatinine &gt;1.5 mg/dl)&#xD;
&#xD;
          8. Anemia (hematocrit &lt;33)&#xD;
&#xD;
          9. Untreated thyroid disease (abnormal TSH)&#xD;
&#xD;
         10. A recent history (&lt;12 months) of GI bleed&#xD;
&#xD;
         11. Diabetes mellitus or other untreated endocrine or metabolic disease&#xD;
&#xD;
         12. Electrolyte abnormalities&#xD;
&#xD;
         13. Any history of stroke, hypo- or hyper-coagulation disorders&#xD;
&#xD;
         14. Recent (3 years) treated cancer other than basal cell carcinoma&#xD;
&#xD;
         15. Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within&#xD;
             12 months&#xD;
&#xD;
         16. Recent (6 months) adherence to a weight-loss or weight-gain diet&#xD;
&#xD;
         17. Weight change of 5% or more in previous 6 months&#xD;
&#xD;
         18. Body mass index &gt;30 or excess body fat that compromises muscle biopsy collection&#xD;
&#xD;
         19. Body mass index &lt;20 or recent history (&lt;12 month) of disordered eating&#xD;
&#xD;
         20. Dietary preferences or practices that preclude the consumption of the study meals&#xD;
&#xD;
         21. Acute infectious disease or chronic infection&#xD;
&#xD;
         22. Alcohol or drug abuse&#xD;
&#xD;
         23. Any other condition or event considered exclusionary by study physician&#xD;
&#xD;
         24. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doug Paddon-Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unversity of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03816579
org study id: 18-0147
nct id: NCT03816579
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To highlight the importance of protein quality rather than the total protein content of a
      meal, the investigators will demonstrate that unlike high quality proteins, a single meal
      containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein
      synthesis. Secondly, the investigators will directly challenge a prevalent, but untested,
      assertion that has the potential to negatively impact health. The goal is to demonstrate that
      complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed
      at the same meal to stimulate protein synthesis.
The investigators will test the following hypotheses in middle-aged men and women (45-60)
      years old using a randomized, cross over design. All study objectives will be met
      concurrently:

        1. Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate
           acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis
           [confirmatory hypothesis]

        2. Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential
           amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein
           synthesis, but to a lesser extent than beef-protein.

        3. A single meal containing 30 g of an incomplete plant-based protein source (PRO-C:
           lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein
           synthesis

        4. Meals containing 30 g of plant-based protein that are incomplete at each separate meal,
           but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle
           protein synthesis.

        5. Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose
           [descriptive]

      If these hypotheses are correct, the investigators will demonstrate that meals containing a
      moderate amount of high quality protein, such as beef, are an efficient and effective way to
      augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a
      prerequisite for outcomes related to physical function, performance, successful aging and
      metabolic health.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Acute muscle protein synthesis: PRO-A
time frame: 3 hours after consuming meal
description: Muscle protein synthesis response to PRO-A breakfast meal (%/h)
measure: Acute muscle protein synthesis: PRO-B
time frame: 3 hours after consuming meal
description: Muscle protein synthesis response to PRO-B breakfast meal (%/h)
measure: Acute muscle protein synthesis: PRO-C
time frame: 3 hours after consuming meal
description: Muscle protein synthesis response to PRO-C breakfast meal (%/h)
measure: Acute muscle protein synthesis: CON
time frame: 3 hours after consuming meal
description: Muscle protein synthesis response to CON breakfast meal (%/hour)
measure: 24-hour muscle protein synthesis: PRO-A
time frame: Approximately 24 hours
description: Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
measure: 24-hour muscle protein synthesis: PRO-B
time frame: Approximately 24 hours
description: Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)
measure: 24-hour muscle protein synthesis: PRO-C
time frame: Approximately 24 hours
description: Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)
measure: Blood amino acid response to diet: PRO-A
time frame: Approximately 5 hours
description: Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
measure: Blood amino acid response to diet: PRO-B
time frame: Approximately 5 hours
description: Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)
measure: Blood amino acid response to diet: PRO-C
time frame: Approximately 5 hours
description: Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)
measure: Blood amino acid response to diet: CON
time frame: Approximately 5 hours
description: Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
measure: Blood glucose response to diet: PRO-A
time frame: Approximately 24 hours
description: Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)
measure: Blood glucose response to diet: PRO-B
time frame: Approximately 24 hours
description: Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)
measure: Blood glucose response to diet: PRO-C
time frame: Approximately 24 hours
description: Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)
measure: Blood glucose response to diet: CON
time frame: Approximately 5 hours
description: Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)
measure: Appetite and Hedonic Questionnaire: PRO-A
time frame: Approximately 8 hours
description: Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-A diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
measure: Appetite and Hedonic Questionnaire: PRO-B
time frame: Approximately 8 hours
description: Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-B diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
measure: Appetite and Hedonic Questionnaire: PRO-C
time frame: Approximately 8 hours
description: Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-C diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
measure: Appetite and Hedonic Questionnaire: CON
time frame: Approximately 5 hours
description: Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to CON diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
measure: 3 day dietary record: PRO-A
time frame: Approximately 36 hours
description: Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit
measure: 3 day dietary record: PRO-B
time frame: Approximately 36 hours
description: Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit
measure: 3 day dietary record: PRO-C
time frame: Approximately 36 hours
description: Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit
measure: 3 day dietary record: CON
time frame: Approximately 36 hours
description: Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit
measure: Palatability Questionnaire:PRO-A
time frame: Approximately 8 hours
description: Questionnaires will be given to assess palatability of the PRO-A diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
measure: Palatability Questionnaire:PRO-B
time frame: Approximately 8 hours
description: Questionnaires will be given to assess palatability of the PRO-B diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
measure: Palatability Questionnaire:PRO-C
time frame: Approximately 8 hours
description: Questionnaires will be given to assess palatability of the PRO-C diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
measure: Palatability Questionnaire:CON
time frame: Approximately 5 hours
description: Questionnaires will be given to assess palatability of the CON diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
arm group label: PRO-A
arm group type: Experimental
description: Beef protein
arm group label: PRO-B
arm group type: Experimental
description: Complementary proteins at each meal
arm group label: PRO-C
arm group type: Experimental
description: Complementary proteins over 24 hours
arm group label: CON
arm group type: No Intervention
description: Low protein (<5 g) meal
intervention type: Other
intervention name: PRO-A
description: 30 g of beef protein will be consumed at each meal
arm group label: PRO-A
intervention type: Other
intervention name: PRO-B
description: 30 g of complementary proteins will be consumed at each meal
arm group label: PRO-B
intervention type: Other
intervention name: PRO-C
description: 30 g of complementary proteins will be consumed over 24 hours
arm group label: PRO-C
criteria: 
gender: All
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Doug Paddon-Jones, PhD
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No