<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/NCT03785951</url>
  </required_header>
  <id_info>
    <org_study_id>17/56</org_study_id>
    <nct_id>NCT03785951</nct_id>
  </id_info>
  <brief_title>Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes</brief_title>
  <acronym>Whey2Glo</acronym>
  <official_title>Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes But With Moderately Raised HbA1c</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Reading</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Barnham Benevolent Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jason and Daphne Mermikides Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Reading</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>
      Higher than average blood sugar (glucose) levels are linked to an increased risk of&#xD;
      developing type 2 diabetes. As such, there is interest in identifying dietary factors that&#xD;
      could lower blood glucose to help reduce the number of people with this disease. Findings&#xD;
      from some human studies indicate that dairy products, especially a milk protein (whey), may&#xD;
      help the control of blood glucose levels. However, there is a need for further studies to&#xD;
      confirm these findings in individuals without diabetes but with higher than average blood&#xD;
      glucose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the UK, more than 700 people are diagnosed with type 2 diabetes each day. Higher than&#xD;
      average (raised) fasting blood sugar (glucose) is a characteristic of those at risk of&#xD;
      developing this disease and as a result there is significant interest in dietary factors that&#xD;
      could reduce levels of blood glucose, lowering the frequency of type 2 diabetes in the&#xD;
      population. Existing scientific evidence suggests an important role of dairy products and&#xD;
      especially of whey protein in the control of blood glucose levels. However, there is a need&#xD;
      for further studies to confirm these findings in individuals without diabetes but with higher&#xD;
      than average blood glucose levels.&#xD;
&#xD;
      Milk contains high quality proteins, of which 80% are caseins and 20% are whey proteins. Whey&#xD;
      proteins are a rich source of branched-chain amino acids (such as leucine) which are thought&#xD;
      to play an important role in regulating blood glucose control and other aspects of&#xD;
      cardiovascular disease development in both healthy and type 2 diabetic subjects. However,&#xD;
      very few studies in non-diabetic subjects with moderately raised HbA1c, characteristic of&#xD;
      long-term poor glucose control, have been performed to investigate how whey protein affects&#xD;
      blood glucose levels in the body especially when consumed over the longer term in the daily&#xD;
      diet. Furthermore, data are limited on whether the leucine content of protein plays an&#xD;
      important role in controlling blood glucose levels.&#xD;
&#xD;
      Study aims The main aims of this study is to investigate in adults without diabetes but with&#xD;
      moderately raised HbA1c (a long- term marker of blood glucose control) whether a protein&#xD;
      obtained from milk and dairy products (whey) has a beneficial effect on fasting and day-long&#xD;
      blood glucose and insulin levels compared with a plant based protein (such as wheat). The&#xD;
      researchers will also determine if leucine, a particular amino acid (building blocks of&#xD;
      protein) found in higher levels in whey protein plays an important role in controlling blood&#xD;
      glucose levels.&#xD;
&#xD;
      A secondary aim will determine whether the protein interventions influence risk markers for&#xD;
      developing heart disease and diabetes including the level of blood lipids, hormones&#xD;
      regulating blood sugar levels and blood vessel health.&#xD;
&#xD;
      This study will test the hypothesis that the incorporation of whey protein (total protein&#xD;
      dose 50 g/d) in the habitual diet for 8 weeks will result in an improvement in fasting and&#xD;
      day-long blood glucose and insulin levels, and other risk markers of heart disease and&#xD;
      diabetes compared with wheat protein (total protein dose 50 g/d), and that the addition of&#xD;
      leucine to wheat (to match the content found in whey protein) will improve blood glucose&#xD;
      control.&#xD;
&#xD;
      Study design This study will be a long term, double-blind, randomised, controlled, three-way,&#xD;
      cross-over study, in which the participants will receive the protein supplements (in random&#xD;
      order) for 8 weeks each, with a 4 week wash-out period between the different protein&#xD;
      treatments. At the beginning and end of each protein intervention, a fasting blood sample&#xD;
      will be collected to determine the longer term effects of the assigned protein supplement on&#xD;
      fasting glycaemic control, insulin sensitivity, endothelial function and other&#xD;
      cardio-metabolic risk markers, as well as non-invasive measures of blood vessel health. At&#xD;
      the beginning of each intervention period, a subset of participants will also undergo a&#xD;
      day-long test meal investigation to determine the short-term (postprandial) effects of the&#xD;
      protein interventions on the study outcome measures in response to standard sequential test&#xD;
      meals containing the assigned protein interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>
    <intervention_model_description>Double-blind, randomised, controlled, 3-way, cross-over study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Coded protein products will be used.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in fasting and day long glucose levels</measure>
    <time_frame>Before and after each 8 week intervention.</time_frame>
    <description>Blood glucose levels will be measured using a clinical chemistry analyser</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasting and day long insulin levels</measure>
    <time_frame>Before and after each 8 week intervention.</time_frame>
    <description>Blood insulin levels will be measured using ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in vascular reactivity measured by Laser Doppler Imaging with iontophoresis</measure>
    <time_frame>Before and after each 8 week intervention.</time_frame>
    <description>Fasting and day long measurement of vascular reactivity in the microcirculation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the total and HDL-cholesterol</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Fasting total cholesterol and HDL-C will be measured using a clinical chemistry analyser. LDL-C will be calculated using the Friedewald formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fructosamine</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Fructosamine will be measured using a clinical chemistry analyser</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive protein</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulse wave analysis</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Pulse wave analysis will be measured using the Mobil-O-Graph device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Systolic blood pressure, diastolic blood pressure and pulse pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cellular adhesion molecule</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>VCAM and ICAM will be measured by Luminex, ICAM, P-selectin and E-selectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in selectins</measure>
    <time_frame>Before the start of the intervention</time_frame>
    <description>P-selectin and E-selectin will be measured using Luminex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in beta-hydroxy butyrate</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Beta-hydroxy butyrate will be measured using a clinical chemistry analyser as a marker of ketone bodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Glucose and insulin levels will be used to estimate insulin sensitivity using the Homeostatic model assessment calculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in non-esterified fatty acids</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Non-esterified fatty acids will be measured using a clinical chemistry analyser</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of height</measure>
    <time_frame>Before the start of the intervention</time_frame>
    <description>Height will be measured using a stadiometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Body weight will be measured using the Tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Body mass index will be calculated from body weight and height measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Body composition will be measured using bioelectrical impedance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Metabonomics</measure>
    <time_frame>Before and after each 8 week intervention</time_frame>
    <description>Urinary biomarkers will be measured using NMR</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pre Diabetes</condition>
  <arm_group>
    <arm_group_label>Whey Protein Isolate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wheat Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are asked to supplement their habitual diet with 56 g of wheat protein a day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wheat protein with leucine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are asked to supplement their habitual diet with 56 g of wheat protein with leucine a day for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein Isolate</intervention_name>
    <description>Whey protein product isolated from whole milk. 79% Protein with minimal carbohydrate and fat.&#xD;
50 grams of total supplemental protein/amino acids from whey protein powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.</description>
    <arm_group_label>Wheat Protein</arm_group_label>
    <arm_group_label>Wheat protein with leucine</arm_group_label>
    <arm_group_label>Whey Protein Isolate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wheat Protein</intervention_name>
    <description>Enzymatically hydrolysed wheat protein containing wheat peptides. 75% Protein with minimal carbohydrate and fat.&#xD;
50 grams of total supplemental protein/amino acids from whet protein peptide powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.</description>
    <arm_group_label>Wheat Protein</arm_group_label>
    <arm_group_label>Wheat protein with leucine</arm_group_label>
    <arm_group_label>Whey Protein Isolate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wheat Protein with Leucine</intervention_name>
    <description>Enzymatically hydrolysed wheat protein containing wheat peptides with and additional 1.4g of L-leucine. 75% Protein with minimal carbohydrate and fat and a L-leucine concentration equal to whey protein isolate.&#xD;
50 grams of total supplemental protein/amino acids from wheat protein peptide powder, with added leucine to equal the total content of the whey protein condition, consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks.</description>
    <arm_group_label>Wheat Protein</arm_group_label>
    <arm_group_label>Wheat protein with leucine</arm_group_label>
    <arm_group_label>Whey Protein Isolate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 20-35 kg/m2&#xD;
&#xD;
          -  HbA1c (5.7 - 6.5%) or (38.8 - 47.5 mmol/mol)&#xD;
&#xD;
          -  Fasting glucose 5.5-6.9 mmol/l&#xD;
&#xD;
          -  Fasting total cholesterol &lt;7.5mmol/l&#xD;
&#xD;
          -  Fasting triacylglycerol &lt;4.0 mmol/l&#xD;
&#xD;
          -  Not having a milk, gluten or wheat allergy or lactose intolerability&#xD;
&#xD;
          -  Not having diabetes (HbA1c &lt; 47 mmol/mol) or &lt; 6.5%&#xD;
&#xD;
          -  Not suffering from cardiovascular, renal, gastrointestinal, respiratory, endocrine or&#xD;
             liver disease&#xD;
&#xD;
          -  Not having hypertension&#xD;
&#xD;
          -  Not diagnosed with cancer&#xD;
&#xD;
          -  Not having surgery in the previous 6 months&#xD;
&#xD;
          -  Not consuming more than the recommended intake of alcohol (&gt;14 unit/wk)&#xD;
&#xD;
          -  Not being a blood donor 3 months prior to or during the study.&#xD;
&#xD;
          -  Not taking extra protein powder supplements in the previous 2 months&#xD;
&#xD;
          -  Not anaemic (Haemoglobin ≥115 g/l for women and ≥ 130 g/l for men)&#xD;
&#xD;
          -  Not taking medication for raised blood lipids, high blood pressure or for inflammatory&#xD;
             conditions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are&#xD;
        not using effective contraceptive precautions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie Lovegrove, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Reading</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julie Lovegrove, Professor</last_name>
    <phone>0044(0)1183786418</phone>
    <phone_ext>6418</phone_ext>
    <email>j.a.lovegrove@reading.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Drew Price, Masters</last_name>
    <phone>00447905106167</phone>
    <email>a.j.price@pgr.reading.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG6 6AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Julie Lovegrove, Professor</last_name>
      <phone>0044(0)1183786418</phone>
      <email>j.a.lovegrove@reading.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Drew Price, Masters</last_name>
      <email>a.j.price@pgr.reading.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Pal S, Ellis V, Dhaliwal S. Effects of whey protein isolate on body composition, lipids, insulin and glucose in overweight and obese individuals. Br J Nutr. 2010 Sep;104(5):716-23. doi: 10.1017/S0007114510000991. Epub 2010 Apr 9.</citation>
    <PMID>20377924</PMID>
  </reference>
  <reference>
    <citation>Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.</citation>
    <PMID>15531672</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Reading</investigator_affiliation>
    <investigator_full_name>Julie Lovegrove</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>HbA1c</keyword>
  <keyword>whey</keyword>
  <keyword>postprandial glycaemia</keyword>
  <keyword>cardiometabolic</keyword>
  <keyword>vascular</keyword>
  <keyword>leucine</keyword>
  <keyword>branched chain amino acids (BCAA)</keyword>
  <keyword>glucose control</keyword>
  <keyword>Milk protein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_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/NCT03785951
org study id: 17/56
nct id: NCT03785951
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Higher than average blood sugar (glucose) levels are linked to an increased risk of
      developing type 2 diabetes. As such, there is interest in identifying dietary factors that
      could lower blood glucose to help reduce the number of people with this disease. Findings
      from some human studies indicate that dairy products, especially a milk protein (whey), may
      help the control of blood glucose levels. However, there is a need for further studies to
      confirm these findings in individuals without diabetes but with higher than average blood
      glucose levels.
In the UK, more than 700 people are diagnosed with type 2 diabetes each day. Higher than
      average (raised) fasting blood sugar (glucose) is a characteristic of those at risk of
      developing this disease and as a result there is significant interest in dietary factors that
      could reduce levels of blood glucose, lowering the frequency of type 2 diabetes in the
      population. Existing scientific evidence suggests an important role of dairy products and
      especially of whey protein in the control of blood glucose levels. However, there is a need
      for further studies to confirm these findings in individuals without diabetes but with higher
      than average blood glucose levels.

      Milk contains high quality proteins, of which 80% are caseins and 20% are whey proteins. Whey
      proteins are a rich source of branched-chain amino acids (such as leucine) which are thought
      to play an important role in regulating blood glucose control and other aspects of
      cardiovascular disease development in both healthy and type 2 diabetic subjects. However,
      very few studies in non-diabetic subjects with moderately raised HbA1c, characteristic of
      long-term poor glucose control, have been performed to investigate how whey protein affects
      blood glucose levels in the body especially when consumed over the longer term in the daily
      diet. Furthermore, data are limited on whether the leucine content of protein plays an
      important role in controlling blood glucose levels.

      Study aims The main aims of this study is to investigate in adults without diabetes but with
      moderately raised HbA1c (a long- term marker of blood glucose control) whether a protein
      obtained from milk and dairy products (whey) has a beneficial effect on fasting and day-long
      blood glucose and insulin levels compared with a plant based protein (such as wheat). The
      researchers will also determine if leucine, a particular amino acid (building blocks of
      protein) found in higher levels in whey protein plays an important role in controlling blood
      glucose levels.

      A secondary aim will determine whether the protein interventions influence risk markers for
      developing heart disease and diabetes including the level of blood lipids, hormones
      regulating blood sugar levels and blood vessel health.

      This study will test the hypothesis that the incorporation of whey protein (total protein
      dose 50 g/d) in the habitual diet for 8 weeks will result in an improvement in fasting and
      day-long blood glucose and insulin levels, and other risk markers of heart disease and
      diabetes compared with wheat protein (total protein dose 50 g/d), and that the addition of
      leucine to wheat (to match the content found in whey protein) will improve blood glucose
      control.

      Study design This study will be a long term, double-blind, randomised, controlled, three-way,
      cross-over study, in which the participants will receive the protein supplements (in random
      order) for 8 weeks each, with a 4 week wash-out period between the different protein
      treatments. At the beginning and end of each protein intervention, a fasting blood sample
      will be collected to determine the longer term effects of the assigned protein supplement on
      fasting glycaemic control, insulin sensitivity, endothelial function and other
      cardio-metabolic risk markers, as well as non-invasive measures of blood vessel health. At
      the beginning of each intervention period, a subset of participants will also undergo a
      day-long test meal investigation to determine the short-term (postprandial) effects of the
      protein interventions on the study outcome measures in response to standard sequential test
      meals containing the assigned protein interventions.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Double-blind, randomised, controlled, 3-way, cross-over study
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Coded protein products will be used.
measure: Change in fasting and day long glucose levels
time frame: Before and after each 8 week intervention.
description: Blood glucose levels will be measured using a clinical chemistry analyser
measure: Change in fasting and day long insulin levels
time frame: Before and after each 8 week intervention.
description: Blood insulin levels will be measured using ELISA
measure: Change in vascular reactivity measured by Laser Doppler Imaging with iontophoresis
time frame: Before and after each 8 week intervention.
description: Fasting and day long measurement of vascular reactivity in the microcirculation.
measure: Change in the total and HDL-cholesterol
time frame: Before and after each 8 week intervention
description: Fasting total cholesterol and HDL-C will be measured using a clinical chemistry analyser. LDL-C will be calculated using the Friedewald formula
measure: Change in fructosamine
time frame: Before and after each 8 week intervention
description: Fructosamine will be measured using a clinical chemistry analyser
measure: Change in C-reactive protein
time frame: Before and after each 8 week intervention
description: C-reactive protein
measure: Change in pulse wave analysis
time frame: Before and after each 8 week intervention
description: Pulse wave analysis will be measured using the Mobil-O-Graph device
measure: Change in blood pressure
time frame: Before and after each 8 week intervention
description: Systolic blood pressure, diastolic blood pressure and pulse pressure
measure: Change in cellular adhesion molecule
time frame: Before and after each 8 week intervention
description: VCAM and ICAM will be measured by Luminex, ICAM, P-selectin and E-selectin
measure: Change in selectins
time frame: Before the start of the intervention
description: P-selectin and E-selectin will be measured using Luminex
measure: Change in beta-hydroxy butyrate
time frame: Before and after each 8 week intervention
description: Beta-hydroxy butyrate will be measured using a clinical chemistry analyser as a marker of ketone bodies
measure: Change in insulin sensitivity
time frame: Before and after each 8 week intervention
description: Glucose and insulin levels will be used to estimate insulin sensitivity using the Homeostatic model assessment calculation
measure: Change in non-esterified fatty acids
time frame: Before and after each 8 week intervention
description: Non-esterified fatty acids will be measured using a clinical chemistry analyser
measure: Measurement of height
time frame: Before the start of the intervention
description: Height will be measured using a stadiometer
measure: Change in body weight
time frame: Before and after each 8 week intervention
description: Body weight will be measured using the Tanita scale
measure: Change in body mass index
time frame: Before and after each 8 week intervention
description: Body mass index will be calculated from body weight and height measurement
measure: Change in body composition
time frame: Before and after each 8 week intervention
description: Body composition will be measured using bioelectrical impedance.
measure: Metabonomics
time frame: Before and after each 8 week intervention
description: Urinary biomarkers will be measured using NMR
arm group label: Whey Protein Isolate
arm group type: Experimental
description: Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks
arm group label: Wheat Protein
arm group type: Experimental
description: Subjects are asked to supplement their habitual diet with 56 g of wheat protein a day for 8 weeks
arm group label: Wheat protein with leucine
arm group type: Experimental
description: Subjects are asked to supplement their habitual diet with 56 g of wheat protein with leucine a day for 8 weeks
intervention type: Dietary Supplement
intervention name: Whey Protein Isolate
description: Whey protein product isolated from whole milk. 79% Protein with minimal carbohydrate and fat.
50 grams of total supplemental protein/amino acids from whey protein powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.
arm group label: Wheat Protein
arm group label: Wheat protein with leucine
arm group label: Whey Protein Isolate
intervention type: Dietary Supplement
intervention name: Wheat Protein
description: Enzymatically hydrolysed wheat protein containing wheat peptides. 75% Protein with minimal carbohydrate and fat.
50 grams of total supplemental protein/amino acids from whet protein peptide powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.
arm group label: Wheat Protein
arm group label: Wheat protein with leucine
arm group label: Whey Protein Isolate
intervention type: Dietary Supplement
intervention name: Wheat Protein with Leucine
description: Enzymatically hydrolysed wheat protein containing wheat peptides with and additional 1.4g of L-leucine. 75% Protein with minimal carbohydrate and fat and a L-leucine concentration equal to whey protein isolate.
50 grams of total supplemental protein/amino acids from wheat protein peptide powder, with added leucine to equal the total content of the whey protein condition, consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks.
arm group label: Wheat Protein
arm group label: Wheat protein with leucine
arm group label: Whey Protein Isolate
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julie Lovegrove, Professor
role: Principal Investigator
affiliation: University of Reading
last name: Julie Lovegrove, Professor
phone: 0044(0)1183786418
phone ext: 6418
email: j.a.lovegrove@reading.ac.uk
last name: Drew Price, Masters
phone: 00447905106167
email: a.j.price@pgr.reading.ac.uk
facility: 
contact: 
contact backup: 
country: United Kingdom
citation: Pal S, Ellis V, Dhaliwal S. Effects of whey protein isolate on body composition, lipids, insulin and glucose in overweight and obese individuals. Br J Nutr. 2010 Sep;104(5):716-23. doi: 10.1017/S0007114510000991. Epub 2010 Apr 9.
PMID: 20377924
citation: Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.
PMID: 15531672
responsible party type: Principal Investigator
investigator affiliation: University of Reading
investigator full name: Julie Lovegrove
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Prediabetic State