<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/NCT03232034</url>
  </required_header>
  <id_info>
    <org_study_id>REACH EP 16/17_164</org_study_id>
    <nct_id>NCT03232034</nct_id>
  </id_info>
  <brief_title>Calcium, Protein and Gut Hormones</brief_title>
  <official_title>The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bath</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2&#xD;
      diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal&#xD;
      ingestion in humans. However, these nutrients may interact synergistically (and with other&#xD;
      minerals in milk) such that specific co-ingestion of these nutrients is required to obtain&#xD;
      the full therapeutic potential for metabolism and energy balance. This proposal is to perform&#xD;
      a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone&#xD;
      responses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not&#xD;
      eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and&#xD;
      encouraged). Participants will then be given one of three test drinks: 1) calcium citrate&#xD;
      (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral&#xD;
      supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these&#xD;
      drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).&#xD;
&#xD;
      Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion&#xD;
      of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY)&#xD;
      circulating in the bloodstream. We will also ask participants to complete an appetite&#xD;
      questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess&#xD;
      their appetite sensations. After the 120-minute time point, we will remove the cannula and&#xD;
      the trial day will be complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</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>Double (Participant, Investigator)</masking>
    <masking_description>Participants and Researchers will be blinded to the interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).</measure>
    <time_frame>120 min</time_frame>
    <description>Plasma glucagon-like peptide-1 (GLP-1) concentrations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial plasma GIP area under the curve (mmol/L x 120 min)</measure>
    <time_frame>120 min</time_frame>
    <description>Plasma glucose-dependent insulinotropic peptide (GIP) concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial plasma PYY area under the curve (mmol/L x 120 min)</measure>
    <time_frame>120 min</time_frame>
    <description>Plasma peptide tyrosine tyrosine (PYY) concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective ratings of appetite (au)</measure>
    <time_frame>120 min</time_frame>
    <description>Visual analogue scales of appetite ratings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy metabolism (carbohydrate and fat oxidation)</measure>
    <time_frame>120 min</time_frame>
    <description>Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial plasma glucose</measure>
    <time_frame>120 min</time_frame>
    <description>Plasma glucose concentrations (mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>120 min</time_frame>
    <description>Systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Calcium Citrate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Calcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Milk Mineral Supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Milk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Milk mineral supplement plus Whey Protein Hydrolysate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium Citrate</intervention_name>
    <description>1000 mg calcium as calcium citrate</description>
    <arm_group_label>Calcium Citrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk Mineral Supplement</intervention_name>
    <description>Milk Minerals containing 1000 mg calcium</description>
    <arm_group_label>Milk Mineral Supplement</arm_group_label>
    <arm_group_label>Milk mineral supplement plus Whey Protein Hydrolysate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein Hydrolysate</intervention_name>
    <description>50 g whey protein hydrolysate</description>
    <arm_group_label>Milk mineral supplement plus Whey Protein Hydrolysate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women age between 18-65 yrs.&#xD;
&#xD;
          -  Able to consume provided supplement.&#xD;
&#xD;
          -  Weigh stable for the past 3 month (no change within 3%).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease&#xD;
&#xD;
          -  Not between the ages of 18-65 years&#xD;
&#xD;
          -  A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your&#xD;
             height (m) squared)&#xD;
&#xD;
          -  Taking medications that may influence your metabolism&#xD;
&#xD;
          -  Plans to change your lifestyle (diet and/or physical activity) during the study period&#xD;
&#xD;
          -  Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day&#xD;
             before the laboratory sessions.&#xD;
&#xD;
          -  Current smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Bath</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>August 26, 2018</last_update_submitted>
  <last_update_submitted_qc>August 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>Javier Gonzalez</investigator_full_name>
    <investigator_title>Lecturer (Assistant Professor) in Human Physiology</investigator_title>
  </responsible_party>
  <keyword>Calcium citrate, dairy product, whey protein, appetite, metabolism</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03232034
org study id: REACH EP 16/17_164
nct id: NCT03232034
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2
      diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal
      ingestion in humans. However, these nutrients may interact synergistically (and with other
      minerals in milk) such that specific co-ingestion of these nutrients is required to obtain
      the full therapeutic potential for metabolism and energy balance. This proposal is to perform
      a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone
      responses.
Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not
      eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and
      encouraged). Participants will then be given one of three test drinks: 1) calcium citrate
      (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral
      supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these
      drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).

      Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion
      of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY)
      circulating in the bloodstream. We will also ask participants to complete an appetite
      questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess
      their appetite sensations. After the 120-minute time point, we will remove the cannula and
      the trial day will be complete.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Participants and Researchers will be blinded to the interventions.
measure: Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
time frame: 120 min
description: Plasma glucagon-like peptide-1 (GLP-1) concentrations
measure: Postprandial plasma GIP area under the curve (mmol/L x 120 min)
time frame: 120 min
description: Plasma glucose-dependent insulinotropic peptide (GIP) concentrations
measure: Postprandial plasma PYY area under the curve (mmol/L x 120 min)
time frame: 120 min
description: Plasma peptide tyrosine tyrosine (PYY) concentrations.
measure: Subjective ratings of appetite (au)
time frame: 120 min
description: Visual analogue scales of appetite ratings
measure: Energy metabolism (carbohydrate and fat oxidation)
time frame: 120 min
description: Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry
measure: Postprandial plasma glucose
time frame: 120 min
description: Plasma glucose concentrations (mmol/L).
measure: Blood pressure
time frame: 120 min
description: Systolic and diastolic blood pressure
arm group label: Calcium Citrate
arm group type: Placebo Comparator
description: Calcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.
arm group label: Milk Mineral Supplement
arm group type: Active Comparator
description: Milk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.
arm group label: Milk mineral supplement plus Whey Protein Hydrolysate
arm group type: Experimental
description: Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.
intervention type: Dietary Supplement
intervention name: Calcium Citrate
description: 1000 mg calcium as calcium citrate
arm group label: Calcium Citrate
intervention type: Dietary Supplement
intervention name: Milk Mineral Supplement
description: Milk Minerals containing 1000 mg calcium
arm group label: Milk Mineral Supplement
arm group label: Milk mineral supplement plus Whey Protein Hydrolysate
intervention type: Dietary Supplement
intervention name: Whey Protein Hydrolysate
description: 50 g whey protein hydrolysate
arm group label: Milk mineral supplement plus Whey Protein Hydrolysate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: Javier Gonzalez
investigator title: Lecturer (Assistant Professor) in Human Physiology
mesh term: Calcium