<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/NCT02258750</url>
  </required_header>
  <id_info>
    <org_study_id>ULKLSA002</org_study_id>
    <nct_id>NCT02258750</nct_id>
  </id_info>
  <brief_title>Assessing a Polydextrose Containing Soup on Food Intake, Appetite and Biomarkers of Satiation and Satiety</brief_title>
  <official_title>Experimental Study to Investigate the Effect of a High Fibre, Polydextrose-enriched Tomato Soup on Food Intake, the Experience of Appetite and Biomarkers of Satiation and Satiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liverpool</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the impact of a soluble fibre (polydextrose) incorporated into a high&#xD;
      fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers of&#xD;
      satiation and satiety over 4-weeks. Specifically, the impact on the development of satiation&#xD;
      within the fixed-load tomato soup containing the fibre, the development of satiety after the&#xD;
      fixed-load meal containing fibre and intake at subsequent ad libitum meals will be examined&#xD;
      as well as the insulin response and carbohydrate fermentation before and after 4-week dosing&#xD;
      of the preload soup.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The science underpinning both short (episodic) and long (tonic) term appetite regulation&#xD;
      demonstrates that foods higher in macronutrients such as fibre can, under certain&#xD;
      experimental conditions, produce great decreases in feelings of hunger and increases in&#xD;
      fullness, post consumption, compared to equi-caloric loads of high carbohydrate or high fat.&#xD;
      Given that fibre increases the release of GLP-1, slows down gastric emptying, prolongs&#xD;
      nutrient absorption and, over long-term use increases the generation of short chain fatty&#xD;
      acids (SCFAs) which have been linked to improved satiety responding, it is plausible that it&#xD;
      will produce strong effects on within meal processes of satiation and satiety over the short-&#xD;
      and long-term. Fibre has also been suggested to influence carbohydrate fermentation (via&#xD;
      generation of these SCFAs) and improve the insulin response, additionally improving satiety.&#xD;
      Ingredients may be added to boost fibre content such as the use of polydextrose, which is a&#xD;
      non-digestible polysaccharide usually used as a dietary fibre in foods. Polydextrose has also&#xD;
      been shown to increase levels of SCFAs due to its slow fermentation and has been related to&#xD;
      reductions in subsequent intake and/or reduced hunger.&#xD;
&#xD;
      The aim of the current study is to assess the impact of a high fibre, polydextrose enriched&#xD;
      tomato soup (experimental) or a low fibre tomato soup (control) on food intake, the&#xD;
      experience of appetite and biomarkers of satiation and satiety.&#xD;
&#xD;
      Sample size: 86 males aged between 18 and 55 years with a body mass index (BMI) of between&#xD;
      23.0 and 28.0 kg/m2. A subset of 28 participants will undergo additional finger prick blood&#xD;
      glucose and hydrogen breath test measures to assess biomarkers of satiation and satiety.&#xD;
      Power calculations to ensure sufficient participants are included were based on power&#xD;
      expected for a medium effect (0.25) at 80% power for a 2 condition between-measures design&#xD;
      using G*power.&#xD;
&#xD;
      Methods: Participants will be invited to three full test day (baseline control, session 1;&#xD;
      first dosing, session 2; one day prior to final dosing, session 3) sessions in which they&#xD;
      will be provided with breakfast (tailored to individual resting metabolic rate (RMR) using&#xD;
      the Schofield equation), the preload condition (receiving a high fibre polydextrose enriched&#xD;
      or control tomato soup) one hour before an ad-libitum lunch and followed four hours later by&#xD;
      an ad-libitum dinner and snack box. All test days will involve the use of standard operating&#xD;
      proceedures. Pre-packaged portions of soup will be provided for a 4-week dosing period&#xD;
      between study sessions 2 and 3 for all participants.&#xD;
&#xD;
      A subset of participants (N=28) will additionally undergo 3 further testing sessions&#xD;
      (baseline control, session 0; second dosing, session 3; final dosing, session 4) in which a&#xD;
      breakfast will be provided followed by the test product with additional glucose and&#xD;
      carbohydrate fermentation measures collected for 3 hours before a light fixed portion meal.&#xD;
&#xD;
      Throughout test days participants will complete visual analogue scales (VAS) for appetite and&#xD;
      palatability as well as questionnaires pertaining to eating behaviour and current sensations&#xD;
      (including a gastrointestinal distress questionnaire).&#xD;
&#xD;
      Statistical analysis: Primary analysis will be comparison of subsequent ad-libitum energy&#xD;
      intake between high fibre polydextrose enriched tomato soup compared to control using ANOVA&#xD;
      and post-hoc tests. Meal duration and various appetite ratings will also be analysed as will&#xD;
      biomarkers of satiety. The specified participant numbers (n=86) give an 80% probability of&#xD;
      detecting an effect on energy intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    End of EU funding for the work package under investigation&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake</measure>
    <time_frame>90 minutes</time_frame>
    <description>Calorie intake at ad-libitum lunch, dinner, and evening snack pack intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>More stable blood glucose response immediately after and after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control</measure>
    <time_frame>180 minutes</time_frame>
    <description>Finger prick blood glucose measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Larger short chain fatty acid fermentation of carbohydrate after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control</measure>
    <time_frame>180 minutes</time_frame>
    <description>Hydrogen breath test measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective experience of satiation after ingestion of high fibre polydextrose enriched tomato soup compared to control</measure>
    <time_frame>30 minutes</time_frame>
    <description>Visual Analogue Scale questionnaires (for appetite) completed before and after the soup and ad-libitum main meals. Questionnaire responses will be compared pre- and post-intervention across the 3 time points (Baseline day, Day 1 and final dosing day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective experience of appetite and palatability in polydextrose tomato soup compared to control</measure>
    <time_frame>60 minutes</time_frame>
    <description>Visual Analogue Scale questionnaires (for appetite and palatability taken before and after each meal (breakfast, soup, lunch, dinner) and at hourly intervals throughout the day. Questionnaire responses will be compared pre- and post-intervention across the 3 time points (Baseline day, Day 1 and final dosing day)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Satiation, Satiety</condition>
  <arm_group>
    <arm_group_label>Polydextrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tomato soup enriched with added polydextrose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tomato soup without added polydextrose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Polydextrose</intervention_name>
    <description>High fibre polydextrose enriched tomato soup (matched for sensory and nutritional characteristics to control) and eaten one hour before an ad-libitum lunch on study days. A 410g pre-packaged portion will be provided which contains 6% polydextrose compared to control.</description>
    <arm_group_label>Polydextrose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Tomato soup (matched for sensory and nutritional characteristics to control) served in a 410g portion and eaten one hour before an ad-libitum lunch on study days.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI of 23-28 kg/m2&#xD;
&#xD;
          -  Not dieting within the last month and not having lost significant amount of weight in&#xD;
             the previous year.&#xD;
&#xD;
          -  Not increased physical activity levels in the past 2-4 weeks or intending to modify&#xD;
             them during the study&#xD;
&#xD;
          -  Able to eat most everyday foods&#xD;
&#xD;
          -  Breakfast eaters&#xD;
&#xD;
          -  Soup consumers&#xD;
&#xD;
          -  Written informed consent to be given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with significant health problems&#xD;
&#xD;
          -  BMI &lt; 23.0 kg/m2 or &gt; 28.0 kg/m2&#xD;
&#xD;
          -  Participants who self-report dieting currently or within the last month or having lost&#xD;
             a significant amount of weight over the previous 6 months.&#xD;
&#xD;
          -  Volunteers who have significantly changed their physical activity patterns in the past&#xD;
             2-4 weeks or who intend to change them during the study&#xD;
&#xD;
          -  Gastrointestinal symptoms requiring treatment.&#xD;
&#xD;
          -  Smokers or those who have recently ceased smoking (including electric cigarettes).&#xD;
&#xD;
          -  Participants receiving systemic or local treatment likely to interfere with evaluation&#xD;
             of the study parameters.&#xD;
&#xD;
          -  Participants who work in the following areas: Nutrition, Dietetics, Food Research,&#xD;
             Food Manufacturing or Supplements Industry.&#xD;
&#xD;
          -  Participants currently adhering to any specific food avoidance diets such as Atkins,&#xD;
             the South Beach diet or low Glycaemic Index (GI).&#xD;
&#xD;
          -  Participants who have had bariatric surgery for weight control or other reason.&#xD;
&#xD;
          -  Non breakfast eaters.&#xD;
&#xD;
          -  Those reporting a history of anaphylaxis to food, significant general food allergies&#xD;
             or specific allergies to any of the study foods.&#xD;
&#xD;
          -  Participants with abnormal eating behaviour&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne A Harrold, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Liverpool</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason CG Halford, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Liverpool</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Liverpool</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L69 7ZA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Flood MT, Auerbach MH, Craig SA. A review of the clinical toleration studies of polydextrose in food. Food Chem Toxicol. 2004 Sep;42(9):1531-42. doi: 10.1016/j.fct.2004.04.015.</citation>
    <PMID>15234083</PMID>
  </reference>
  <reference>
    <citation>King NA, Craig SA, Pepper T, Blundell JE. Evaluation of the independent and combined effects of xylitol and polydextrose consumed as a snack on hunger and energy intake over 10 d. Br J Nutr. 2005 Jun;93(6):911-5. doi: 10.1079/bjn20051431.</citation>
    <PMID>16022761</PMID>
  </reference>
  <reference>
    <citation>Ranawana V, Muller A, Henry CJ. Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males-a randomized controlled cross-over study. Eur J Nutr. 2013 Apr;52(3):885-93. doi: 10.1007/s00394-012-0395-4. Epub 2012 Jun 21.</citation>
    <PMID>22717960</PMID>
  </reference>
  <reference>
    <citation>Schwab U, Louheranta A, Torronen A, Uusitupa M. Impact of sugar beet pectin and polydextrose on fasting and postprandial glycemia and fasting concentrations of serum total and lipoprotein lipids in middle-aged subjects with abnormal glucose metabolism. Eur J Clin Nutr. 2006 Sep;60(9):1073-80. doi: 10.1038/sj.ejcn.1602421. Epub 2006 Mar 8.</citation>
    <PMID>16523204</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>January 6, 2016</last_update_submitted>
  <last_update_submitted_qc>January 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liverpool</investigator_affiliation>
    <investigator_full_name>Dr. Una Masic</investigator_full_name>
    <investigator_title>Post-Doctoral Associate</investigator_title>
  </responsible_party>
  <!-- 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/NCT02258750
org study id: ULKLSA002
nct id: NCT02258750
lead sponsor: 
has dmc: No
This study will examine the impact of a soluble fibre (polydextrose) incorporated into a high
      fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers of
      satiation and satiety over 4-weeks. Specifically, the impact on the development of satiation
      within the fixed-load tomato soup containing the fibre, the development of satiety after the
      fixed-load meal containing fibre and intake at subsequent ad libitum meals will be examined
      as well as the insulin response and carbohydrate fermentation before and after 4-week dosing
      of the preload soup.
The science underpinning both short (episodic) and long (tonic) term appetite regulation
      demonstrates that foods higher in macronutrients such as fibre can, under certain
      experimental conditions, produce great decreases in feelings of hunger and increases in
      fullness, post consumption, compared to equi-caloric loads of high carbohydrate or high fat.
      Given that fibre increases the release of GLP-1, slows down gastric emptying, prolongs
      nutrient absorption and, over long-term use increases the generation of short chain fatty
      acids (SCFAs) which have been linked to improved satiety responding, it is plausible that it
      will produce strong effects on within meal processes of satiation and satiety over the short-
      and long-term. Fibre has also been suggested to influence carbohydrate fermentation (via
      generation of these SCFAs) and improve the insulin response, additionally improving satiety.
      Ingredients may be added to boost fibre content such as the use of polydextrose, which is a
      non-digestible polysaccharide usually used as a dietary fibre in foods. Polydextrose has also
      been shown to increase levels of SCFAs due to its slow fermentation and has been related to
      reductions in subsequent intake and/or reduced hunger.

      The aim of the current study is to assess the impact of a high fibre, polydextrose enriched
      tomato soup (experimental) or a low fibre tomato soup (control) on food intake, the
      experience of appetite and biomarkers of satiation and satiety.

      Sample size: 86 males aged between 18 and 55 years with a body mass index (BMI) of between
      23.0 and 28.0 kg/m2. A subset of 28 participants will undergo additional finger prick blood
      glucose and hydrogen breath test measures to assess biomarkers of satiation and satiety.
      Power calculations to ensure sufficient participants are included were based on power
      expected for a medium effect (0.25) at 80% power for a 2 condition between-measures design
      using G*power.

      Methods: Participants will be invited to three full test day (baseline control, session 1;
      first dosing, session 2; one day prior to final dosing, session 3) sessions in which they
      will be provided with breakfast (tailored to individual resting metabolic rate (RMR) using
      the Schofield equation), the preload condition (receiving a high fibre polydextrose enriched
      or control tomato soup) one hour before an ad-libitum lunch and followed four hours later by
      an ad-libitum dinner and snack box. All test days will involve the use of standard operating
      proceedures. Pre-packaged portions of soup will be provided for a 4-week dosing period
      between study sessions 2 and 3 for all participants.

      A subset of participants (N=28) will additionally undergo 3 further testing sessions
      (baseline control, session 0; second dosing, session 3; final dosing, session 4) in which a
      breakfast will be provided followed by the test product with additional glucose and
      carbohydrate fermentation measures collected for 3 hours before a light fixed portion meal.

      Throughout test days participants will complete visual analogue scales (VAS) for appetite and
      palatability as well as questionnaires pertaining to eating behaviour and current sensations
      (including a gastrointestinal distress questionnaire).

      Statistical analysis: Primary analysis will be comparison of subsequent ad-libitum energy
      intake between high fibre polydextrose enriched tomato soup compared to control using ANOVA
      and post-hoc tests. Meal duration and various appetite ratings will also be analysed as will
      biomarkers of satiety. The specified participant numbers (n=86) give an 80% probability of
      detecting an effect on energy intake.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake
time frame: 90 minutes
description: Calorie intake at ad-libitum lunch, dinner, and evening snack pack intake
measure: More stable blood glucose response immediately after and after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control
time frame: 180 minutes
description: Finger prick blood glucose measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)
measure: Larger short chain fatty acid fermentation of carbohydrate after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control
time frame: 180 minutes
description: Hydrogen breath test measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)
measure: Changes in subjective experience of satiation after ingestion of high fibre polydextrose enriched tomato soup compared to control
time frame: 30 minutes
description: Visual Analogue Scale questionnaires (for appetite) completed before and after the soup and ad-libitum main meals. Questionnaire responses will be compared pre- and post-intervention across the 3 time points (Baseline day, Day 1 and final dosing day)
measure: Changes in subjective experience of appetite and palatability in polydextrose tomato soup compared to control
time frame: 60 minutes
description: Visual Analogue Scale questionnaires (for appetite and palatability taken before and after each meal (breakfast, soup, lunch, dinner) and at hourly intervals throughout the day. Questionnaire responses will be compared pre- and post-intervention across the 3 time points (Baseline day, Day 1 and final dosing day)
arm group label: Polydextrose
arm group type: Experimental
description: Tomato soup enriched with added polydextrose
arm group label: Control
arm group type: Placebo Comparator
description: Tomato soup without added polydextrose
intervention type: Dietary Supplement
intervention name: Polydextrose
description: High fibre polydextrose enriched tomato soup (matched for sensory and nutritional characteristics to control) and eaten one hour before an ad-libitum lunch on study days. A 410g pre-packaged portion will be provided which contains 6% polydextrose compared to control.
arm group label: Polydextrose
intervention type: Other
intervention name: Control
description: Tomato soup (matched for sensory and nutritional characteristics to control) served in a 410g portion and eaten one hour before an ad-libitum lunch on study days.
arm group label: Control
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne A Harrold, Doctor
role: Principal Investigator
affiliation: University of Liverpool
last name: Jason CG Halford, Professor
role: Principal Investigator
affiliation: University of Liverpool
facility: 
country: United Kingdom
citation: Flood MT, Auerbach MH, Craig SA. A review of the clinical toleration studies of polydextrose in food. Food Chem Toxicol. 2004 Sep;42(9):1531-42. doi: 10.1016/j.fct.2004.04.015.
PMID: 15234083
citation: King NA, Craig SA, Pepper T, Blundell JE. Evaluation of the independent and combined effects of xylitol and polydextrose consumed as a snack on hunger and energy intake over 10 d. Br J Nutr. 2005 Jun;93(6):911-5. doi: 10.1079/bjn20051431.
PMID: 16022761
citation: Ranawana V, Muller A, Henry CJ. Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males-a randomized controlled cross-over study. Eur J Nutr. 2013 Apr;52(3):885-93. doi: 10.1007/s00394-012-0395-4. Epub 2012 Jun 21.
PMID: 22717960
citation: Schwab U, Louheranta A, Torronen A, Uusitupa M. Impact of sugar beet pectin and polydextrose on fasting and postprandial glycemia and fasting concentrations of serum total and lipoprotein lipids in middle-aged subjects with abnormal glucose metabolism. Eur J Clin Nutr. 2006 Sep;60(9):1073-80. doi: 10.1038/sj.ejcn.1602421. Epub 2006 Mar 8.
PMID: 16523204
responsible party type: Principal Investigator
investigator affiliation: University of Liverpool
investigator full name: Dr. Una Masic
investigator title: Post-Doctoral Associate