<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/NCT03306706</url>
  </required_header>
  <id_info>
    <org_study_id>RRC/2017/1702</org_study_id>
    <secondary_id>HS21108 (B2017:106)</secondary_id>
    <nct_id>NCT03306706</nct_id>
  </id_info>
  <brief_title>Effect of Peas in Muffins on Blood Glucose and Appetite Control</brief_title>
  <acronym>PEA3</acronym>
  <official_title>A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Muffins on Post-prandial Glycaemic Response and Satiety in Healthy Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Boniface Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agriculture and Agri-Food Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Boniface Hospital</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>
      This study is part of a group of studies whose overall goal is to accurately define the&#xD;
      physiochemical and structural effects of pea varieties and relate these to blood glucose&#xD;
      attenuation and appetite related sensations in healthy human volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, controlled, cross-over study designed to examine the postprandial glycaemic&#xD;
      response and appetite related sensations to peas in muffins will be conducted at the I.H.&#xD;
      Asper Clinical Research Institute in Winnipeg, Manitoba. Eligible participants who have&#xD;
      provided consent will be asked to attend 4 clinic visits in a fasted state. Participants will&#xD;
      be given muffins containing peas at 2 visits and muffins without peas at 2 visits. At each&#xD;
      visit participants will provide 7 venous blood samples via indwelling catheter, 7 capillary&#xD;
      blood samples via finger poke, 2 urine samples, 5 questionnaires about their appetite and a&#xD;
      questionnaire about the acceptability of the products. At the end of each visit, participants&#xD;
      will eat pizza ad libitum, and the amount of pizza consumed will be measured to determine if&#xD;
      the peas influenced the amount of calories consumed at lunch. Participants will record their&#xD;
      food/beverage intake for the rest of the day. Each visit will last approximately 3h and be&#xD;
      separated by 3-14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Actual">February 21, 2019</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>randomized, controlled, cross-over</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-prandial glucose response</measure>
    <time_frame>120 min</time_frame>
    <description>iAUC glucose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-prandial insulin</measure>
    <time_frame>120 min</time_frame>
    <description>iAUC insulin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appetite ratings</measure>
    <time_frame>120 min</time_frame>
    <description>AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales</description>
  </secondary_outcome>
  <other_outcome>
    <measure>calorie intake</measure>
    <time_frame>16 hours</time_frame>
    <description>Number of calories consumed post-intervention until bedtime</description>
  </other_outcome>
  <other_outcome>
    <measure>Metabolomics</measure>
    <time_frame>120 min</time_frame>
    <description>Metabolite profile in plasma and urine</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability of test products</measure>
    <time_frame>15 min</time_frame>
    <description>Rating of color, aroma, flavor, texture and frequency of eating</description>
  </other_outcome>
  <other_outcome>
    <measure>Gastrointestinal side effects</measure>
    <time_frame>24h</time_frame>
    <description>Incidence and duration of GI side effects</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Post-prandial Glycaemic Response</condition>
  <condition>Satiety</condition>
  <arm_group>
    <arm_group_label>whole yellow pea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 muffins containing 25g available carbohydrate from whole yellow peas. Intervention: Whole pea muffins</description>
  </arm_group>
  <arm_group>
    <arm_group_label>split yellow pea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 muffins containing 25g available carbohydrate from split yellow peas. Intervention: Split pea muffins</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wheat-PPGR</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 muffins containing 25g available carbohydrate from wheat flour. Intervention: Wheat muffins</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wheat-satiety</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 muffins containing wheat flour to match the calories in the whole and split pea muffins.&#xD;
Intervention: Wheat muffins</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whole pea muffins</intervention_name>
    <description>2 muffins containing whole peas</description>
    <arm_group_label>whole yellow pea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Split pea muffins</intervention_name>
    <description>2 muffins containing split peas</description>
    <arm_group_label>split yellow pea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wheat muffins</intervention_name>
    <description>2 muffins containing wheat</description>
    <arm_group_label>wheat-PPGR</arm_group_label>
    <arm_group_label>wheat-satiety</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Generally healthy male or female, between the age of 18-40 years;&#xD;
&#xD;
          2. Body mass index (BMI) 18.5-30.0 kg/m2;&#xD;
&#xD;
          3. Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening,&#xD;
             respectively.&#xD;
&#xD;
          4. Willing to provide informed consent;&#xD;
&#xD;
          5. Willing/able to comply with the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating;&#xD;
&#xD;
          2. Medical history of diabetes mellitus, fasting blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%,&#xD;
             or use of insulin or oral medication to control blood sugar;&#xD;
&#xD;
          3. Medical history of cardiovascular disease;&#xD;
&#xD;
          4. Systolic blood pressure &gt;140 mmHg or diastolic blood pressure &gt;90 mmHg;&#xD;
&#xD;
          5. Fasting plasma total cholesterol &gt;7.8 mmol/L;&#xD;
&#xD;
          6. Fasting plasma HDL &lt;0.9 mmol/L;&#xD;
&#xD;
          7. Fasting plasma LDL &gt;5.0 mmol/L;&#xD;
&#xD;
          8. Fasting plasma triglycerides &gt;2.3 mmol/L;&#xD;
&#xD;
          9. Major surgery within the last 3 months;&#xD;
&#xD;
         10. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid&#xD;
             arthritis, psoriasis) or use of any corticosteroid medications within 3 months;&#xD;
&#xD;
         11. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT&#xD;
             ≥1.5 times the upper limit of normal (ULN));&#xD;
&#xD;
         12. Medical history of kidney disease or kidney dysfunction (defined as blood urea&#xD;
             nitrogen and creatinine ≥ 1.8 times the ULN));&#xD;
&#xD;
         13. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering&#xD;
             medications or laxatives (including fibre supplements) within the past month or&#xD;
             antibiotic use within the past 6 weeks;&#xD;
&#xD;
         14. Active treatment for any type of cancer within 1 year prior to study start;&#xD;
&#xD;
         15. Shift worker (a system of employment where an individual's normal hours of work are in&#xD;
             part, outside the period of normal working day; 6am and 8pm);&#xD;
&#xD;
         16. Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);&#xD;
&#xD;
         17. Allergies to peas;&#xD;
&#xD;
         18. Aversion or unwillingness to eat study foods;&#xD;
&#xD;
         19. Consuming &gt;4 servings of pulses per week;&#xD;
&#xD;
         20. Use of any prescription or non-prescription drug, herbal or nutritional supplement&#xD;
             known to affect glycaemia or appetite;&#xD;
&#xD;
         21. Participation in another clinical trial, current or in the past 4 weeks;&#xD;
&#xD;
         22. Unstable body weight (defined as &gt;5% change in 3 months) or actively participating in&#xD;
             a weight loss program.&#xD;
&#xD;
         23. Physical Activity Level &gt;1.8.&#xD;
&#xD;
         24. Restraint score &gt;13 (factor 1) on the Three Factor Eating Questionnaire.&#xD;
&#xD;
         25. Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             principal Investigator may interfere with study participation or the ability to follow&#xD;
             the intervention protocol;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather Blewett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Agriculture and Agri-Food Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>I.H. Asper Clinical Research Institute</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Public Health Agency of Canada and the Canadian Institute for Health Information. Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian institute for health information. Government of Canada; 2011.</citation>
  </reference>
  <reference>
    <citation>Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011</citation>
  </reference>
  <reference>
    <citation>Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.</citation>
    <PMID>19526214</PMID>
  </reference>
  <reference>
    <citation>Hamberg O, Rumessen JJ, Gudmand-Hoyer E. Blood glucose response to pea fiber: comparisons with sugar beet fiber and wheat bran. Am J Clin Nutr. 1989 Aug;50(2):324-8. doi: 10.1093/ajcn/50.2.324.</citation>
    <PMID>2547300</PMID>
  </reference>
  <reference>
    <citation>Marinangeli CP, Jones PJ. Chronic intake of fractionated yellow pea flour reduces postprandial energy expenditure and carbohydrate oxidation. J Med Food. 2011 Dec;14(12):1654-62. doi: 10.1089/jmf.2010.0255.</citation>
    <PMID>22145774</PMID>
  </reference>
  <reference>
    <citation>Smith CE, Mollard RC, Luhovyy BL, Anderson GH. The effect of yellow pea protein and fibre on short-term food intake, subjective appetite and glycaemic response in healthy young men. Br J Nutr. 2012 Aug;108 Suppl 1:S74-80. doi: 10.1017/S0007114512000700.</citation>
    <PMID>22916818</PMID>
  </reference>
  <reference>
    <citation>Jenkins DJ, Thorne MJ, Camelon K, Jenkins A, Rao AV, Taylor RH, Thompson LU, Kalmusky J, Reichert R, Francis T. Effect of processing on digestibility and the blood glucose response: a study of lentils. Am J Clin Nutr. 1982 Dec;36(6):1093-101. doi: 10.1093/ajcn/36.6.1093.</citation>
    <PMID>6293296</PMID>
  </reference>
  <reference>
    <citation>Li H, Song F, Xing J, Tsao R, Liu Z, Liu S. Screening and structural characterization of alpha-glucosidase inhibitors from hawthorn leaf flavonoids extract by ultrafiltration LC-DAD-MS(n) and SORI-CID FTICR MS. J Am Soc Mass Spectrom. 2009 Aug;20(8):1496-503. doi: 10.1016/j.jasms.2009.04.003. Epub 2009 Apr 14.</citation>
    <PMID>19443236</PMID>
  </reference>
  <reference>
    <citation>Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.</citation>
    <PMID>21425674</PMID>
  </reference>
  <reference>
    <citation>Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.</citation>
    <PMID>20122136</PMID>
  </reference>
  <reference>
    <citation>European Food Safety Authority. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal. 2012;10(3):2604.</citation>
  </reference>
  <reference>
    <citation>Health Canada. Draft guidance document: Satiety health claims on food [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/consult/satiety-satiete/document-consultation-eng.php</citation>
  </reference>
  <reference>
    <citation>Ames N, Blewett H, Storsley J, Thandapilly SJ, Zahradka P, Taylor C. A double-blind randomised controlled trial testing the effect of a barley product containing varying amounts and types of fibre on the postprandial glucose response of healthy volunteers. Br J Nutr. 2015 May 14;113(9):1373-83. doi: 10.1017/S0007114515000367. Epub 2015 Apr 8.</citation>
    <PMID>25850814</PMID>
  </reference>
  <reference>
    <citation>Johansson G, Westerterp KR. Assessment of the physical activity level with two questions: validation with doubly labeled water. Int J Obes (Lond). 2008 Jun;32(6):1031-3. doi: 10.1038/ijo.2008.42. Epub 2008 Apr 8.</citation>
    <PMID>18392036</PMID>
  </reference>
  <reference>
    <citation>Rabiee A, Magruder JT, Grant C, Salas-Carrillo R, Gillette A, DuBois J, Shannon RP, Andersen DK, Elahi D. Accuracy and reliability of the Nova StatStrip(R) glucose meter for real-time blood glucose determinations during glucose clamp studies. J Diabetes Sci Technol. 2010 Sep 1;4(5):1195-201. doi: 10.1177/193229681000400519.</citation>
    <PMID>20920440</PMID>
  </reference>
  <reference>
    <citation>Mollard RC, Luhovyy BL, Smith C, Anderson GH. Acute effects of pea protein and hull fibre alone and combined on blood glucose, appetite, and food intake in healthy young men--a randomized crossover trial. Appl Physiol Nutr Metab. 2014 Dec;39(12):1360-5. doi: 10.1139/apnm-2014-0170. Epub 2014 Aug 2.</citation>
    <PMID>25302637</PMID>
  </reference>
  <reference>
    <citation>Akhavan T, Anderson GH. Effects of glucose-to-fructose ratios in solutions on subjective satiety, food intake, and satiety hormones in young men. Am J Clin Nutr. 2007 Nov;86(5):1354-63. doi: 10.1093/ajcn/86.5.1354.</citation>
    <PMID>17991646</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Boniface Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Heather Blewett</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>blood sugar</keyword>
  <keyword>insulin</keyword>
  <keyword>appetite</keyword>
  <keyword>peas</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Once data has been collected until manuscript is accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Dan Ramdath, Sora Ludwig and Michel Aliani will have access to data necessary for manuscript preparation.</ipd_access_criteria>
  </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/NCT03306706
org study id: RRC/2017/1702
secondary id: HS21108 (B2017:106)
nct id: NCT03306706
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is part of a group of studies whose overall goal is to accurately define the
      physiochemical and structural effects of pea varieties and relate these to blood glucose
      attenuation and appetite related sensations in healthy human volunteers.
A randomized, controlled, cross-over study designed to examine the postprandial glycaemic
      response and appetite related sensations to peas in muffins will be conducted at the I.H.
      Asper Clinical Research Institute in Winnipeg, Manitoba. Eligible participants who have
      provided consent will be asked to attend 4 clinic visits in a fasted state. Participants will
      be given muffins containing peas at 2 visits and muffins without peas at 2 visits. At each
      visit participants will provide 7 venous blood samples via indwelling catheter, 7 capillary
      blood samples via finger poke, 2 urine samples, 5 questionnaires about their appetite and a
      questionnaire about the acceptability of the products. At the end of each visit, participants
      will eat pizza ad libitum, and the amount of pizza consumed will be measured to determine if
      the peas influenced the amount of calories consumed at lunch. Participants will record their
      food/beverage intake for the rest of the day. Each visit will last approximately 3h and be
      separated by 3-14 days.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomized, controlled, cross-over
primary purpose: Prevention
masking: None (Open Label)
measure: Post-prandial glucose response
time frame: 120 min
description: iAUC glucose
measure: Post-prandial insulin
time frame: 120 min
description: iAUC insulin
measure: Appetite ratings
time frame: 120 min
description: AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales
measure: calorie intake
time frame: 16 hours
description: Number of calories consumed post-intervention until bedtime
measure: Metabolomics
time frame: 120 min
description: Metabolite profile in plasma and urine
measure: Acceptability of test products
time frame: 15 min
description: Rating of color, aroma, flavor, texture and frequency of eating
measure: Gastrointestinal side effects
time frame: 24h
description: Incidence and duration of GI side effects
arm group label: whole yellow pea
arm group type: Experimental
description: 2 muffins containing 25g available carbohydrate from whole yellow peas. Intervention: Whole pea muffins
arm group label: split yellow pea
arm group type: Experimental
description: 2 muffins containing 25g available carbohydrate from split yellow peas. Intervention: Split pea muffins
arm group label: wheat-PPGR
arm group type: Placebo Comparator
description: 2 muffins containing 25g available carbohydrate from wheat flour. Intervention: Wheat muffins
arm group label: wheat-satiety
arm group type: Placebo Comparator
description: 2 muffins containing wheat flour to match the calories in the whole and split pea muffins.
Intervention: Wheat muffins
intervention type: Dietary Supplement
intervention name: Whole pea muffins
description: 2 muffins containing whole peas
arm group label: whole yellow pea
intervention type: Dietary Supplement
intervention name: Split pea muffins
description: 2 muffins containing split peas
arm group label: split yellow pea
intervention type: Dietary Supplement
intervention name: Wheat muffins
description: 2 muffins containing wheat
arm group label: wheat-PPGR
arm group label: wheat-satiety
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heather Blewett, PhD
role: Principal Investigator
affiliation: Agriculture and Agri-Food Canada
facility: 
country: Canada
citation: Public Health Agency of Canada and the Canadian Institute for Health Information. Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian institute for health information. Government of Canada; 2011.
citation: Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011
citation: Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
PMID: 19526214
citation: Hamberg O, Rumessen JJ, Gudmand-Hoyer E. Blood glucose response to pea fiber: comparisons with sugar beet fiber and wheat bran. Am J Clin Nutr. 1989 Aug;50(2):324-8. doi: 10.1093/ajcn/50.2.324.
PMID: 2547300
citation: Marinangeli CP, Jones PJ. Chronic intake of fractionated yellow pea flour reduces postprandial energy expenditure and carbohydrate oxidation. J Med Food. 2011 Dec;14(12):1654-62. doi: 10.1089/jmf.2010.0255.
PMID: 22145774
citation: Smith CE, Mollard RC, Luhovyy BL, Anderson GH. The effect of yellow pea protein and fibre on short-term food intake, subjective appetite and glycaemic response in healthy young men. Br J Nutr. 2012 Aug;108 Suppl 1:S74-80. doi: 10.1017/S0007114512000700.
PMID: 22916818
citation: Jenkins DJ, Thorne MJ, Camelon K, Jenkins A, Rao AV, Taylor RH, Thompson LU, Kalmusky J, Reichert R, Francis T. Effect of processing on digestibility and the blood glucose response: a study of lentils. Am J Clin Nutr. 1982 Dec;36(6):1093-101. doi: 10.1093/ajcn/36.6.1093.
PMID: 6293296
citation: Li H, Song F, Xing J, Tsao R, Liu Z, Liu S. Screening and structural characterization of alpha-glucosidase inhibitors from hawthorn leaf flavonoids extract by ultrafiltration LC-DAD-MS(n) and SORI-CID FTICR MS. J Am Soc Mass Spectrom. 2009 Aug;20(8):1496-503. doi: 10.1016/j.jasms.2009.04.003. Epub 2009 Apr 14.
PMID: 19443236
citation: Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.
PMID: 21425674
citation: Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
PMID: 20122136
citation: European Food Safety Authority. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal. 2012;10(3):2604.
citation: Health Canada. Draft guidance document: Satiety health claims on food [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/consult/satiety-satiete/document-consultation-eng.php
citation: Ames N, Blewett H, Storsley J, Thandapilly SJ, Zahradka P, Taylor C. A double-blind randomised controlled trial testing the effect of a barley product containing varying amounts and types of fibre on the postprandial glucose response of healthy volunteers. Br J Nutr. 2015 May 14;113(9):1373-83. doi: 10.1017/S0007114515000367. Epub 2015 Apr 8.
PMID: 25850814
citation: Johansson G, Westerterp KR. Assessment of the physical activity level with two questions: validation with doubly labeled water. Int J Obes (Lond). 2008 Jun;32(6):1031-3. doi: 10.1038/ijo.2008.42. Epub 2008 Apr 8.
PMID: 18392036
citation: Rabiee A, Magruder JT, Grant C, Salas-Carrillo R, Gillette A, DuBois J, Shannon RP, Andersen DK, Elahi D. Accuracy and reliability of the Nova StatStrip(R) glucose meter for real-time blood glucose determinations during glucose clamp studies. J Diabetes Sci Technol. 2010 Sep 1;4(5):1195-201. doi: 10.1177/193229681000400519.
PMID: 20920440
citation: Mollard RC, Luhovyy BL, Smith C, Anderson GH. Acute effects of pea protein and hull fibre alone and combined on blood glucose, appetite, and food intake in healthy young men--a randomized crossover trial. Appl Physiol Nutr Metab. 2014 Dec;39(12):1360-5. doi: 10.1139/apnm-2014-0170. Epub 2014 Aug 2.
PMID: 25302637
citation: Akhavan T, Anderson GH. Effects of glucose-to-fructose ratios in solutions on subjective satiety, food intake, and satiety hormones in young men. Am J Clin Nutr. 2007 Nov;86(5):1354-63. doi: 10.1093/ajcn/86.5.1354.
PMID: 17991646
responsible party type: Principal Investigator
investigator affiliation: St. Boniface Hospital
investigator full name: Dr. Heather Blewett
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Once data has been collected until manuscript is accepted for publication.
ipd access criteria: Dan Ramdath, Sora Ludwig and Michel Aliani will have access to data necessary for manuscript preparation.