<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/NCT01724411</url>
  </required_header>
  <id_info>
    <org_study_id>2/040/12</org_study_id>
    <secondary_id>289800</secondary_id>
    <secondary_id>2012RW002</secondary_id>
    <nct_id>NCT01724411</nct_id>
  </id_info>
  <brief_title>Satiety Innovation- Study 793. University of Aberdeen</brief_title>
  <acronym>SATIN</acronym>
  <official_title>SATIN: Satiety Innovation, Study 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>P Burns</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Københavns Universitet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de Murcia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Rovira i Virgili</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cargill</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Coca-Cola Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Juver Alimentación S.L.U</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naturex, Spain</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Axxam S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>BioActor</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Tecnológico Nacional Agroalimentario Extremadura</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Tecnológico Nacional de la Conserva y Alimentación</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NIZO Food Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RTD Services Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ProDigest</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aberdeen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will address the effect of developed novel food products through&#xD;
      processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability&#xD;
      and gut health using in vivo studies and validating new in vivo approaches.&#xD;
&#xD;
      Specifically in this protocol we will address, in a short human intervention study the effect&#xD;
      of a potentially satiating product on appetite, appetite biomarkers, particularly the&#xD;
      influence on gut microbiota, tolerance and safety of the products in healthy obese and&#xD;
      overweight volunteers in free living conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous research has suggested that food structure and food composition has a role to play&#xD;
      in controlling consumption. Low-energy, high-fibre diets provide physical bulk in the&#xD;
      gastro-intestinal tract to sustain fullness in a way that low-volume, energy-dense foods&#xD;
      cannot. However, studies shown low long term acceptability be probably associated to its poor&#xD;
      palatability. Taste and hedonic experience remain the main drivers of consumer choice, and&#xD;
      the immediate sensory aspect of food products such as palatability to have greater salience&#xD;
      to consumers than their health promoting properties.&#xD;
&#xD;
      Changing the properties of foods merely by changing oro-sensory properties and through the&#xD;
      delay of gastric emptying deals with mechanisms critical to within-meal satiation and early&#xD;
      post meal satiety and may produce only transient suppression of hunger unless regularly&#xD;
      consumed and represent benefits in delivering nutritional stimuli to key parts of the&#xD;
      gastro-intestinal tract. The potential to manufacture change can make food structure variety&#xD;
      now seem near limitless due the numerous advances in food technology.&#xD;
&#xD;
      Several recent reports have associated satiety effects with fermentable fibre sources in&#xD;
      human dietary studies (Nillson et al., 2008, Parnell &amp; Weimer, 2009, Willis et al 2009).&#xD;
      Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might&#xD;
      contributes to obesity (Ley et al., 2006, Turnbaugh et al., 2008, Cani et al., 2007).&#xD;
      However, the different mechanisms involved in lean and obese subjects are not completely&#xD;
      resolved (Duncan et al., 2008, Schwiertz et al., 2010). Recent evidence in experimental&#xD;
      animal designs indicates that changes in gut microbiota composition may be associated with&#xD;
      increased food intake and obesity (Vijay-Kumar et al., 2010) suggesting that satiety and&#xD;
      intake are influenced by the species composition of the gut microbiota.&#xD;
&#xD;
      The proposed study will address the effect of developed novel food products through&#xD;
      processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability&#xD;
      and gut health using in vivo studies and validating new in vivo approaches. Specifically in&#xD;
      this protocol we will address the effect of a potentially satiating product on appetite,&#xD;
      appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of&#xD;
      the products in healthy obese and overweight volunteers in free living conditions. This study&#xD;
      is part of the major European project launched in early 2011: SATIN, a collaborative,&#xD;
      large-scale project that brings together the expertise of 18 participants across Europe to&#xD;
      develop food products through novel food process that enhance satiety.&#xD;
&#xD;
      This short-term human nutrition study comprises in a cross-over design testing either a&#xD;
      potentially satiety product, resistant starch type 3 (RS3) or an equivalent amount&#xD;
      heterogeneous natural fibre in 24 healthy- obese volunteers, aged 18-65 years old, Body Mass&#xD;
      Index (BMI) between 27 and 35kg/m2 from both genders after an initial 21 day weight-loss&#xD;
      programme, in free- living conditions. Dietary intake, body weight, blood pressure would be&#xD;
      monitored through the study. Faecal, urine and blood samples will be collected to monitor,&#xD;
      glucose, insulin, gut peptides and assess metabolites of dietary and microbial origin. Gut&#xD;
      transit will be monitored in six volunteers using a wireless motility device (SmartPill™)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of RS on weight loss</measure>
    <time_frame>52 days</time_frame>
    <description>During this part of the study the effect of novel fibre (RS3)on weight loss will be assessed after dietary intervention. This will consist of a weight loss plan (21 days) and two maintenance periods (11 days) either with RS3 or no.&#xD;
Changes in weight, BMI and total and regional body composition information using a two compartment model (fat mass and fat free mass by air displacement densitometry -Bod-Pod) will be assessed at the end of each dietary intervention. Resting Metabolic Rate will be assessed the beginning and at the end of the weight loss diet (Deltatrac).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of RS on gut health</measure>
    <time_frame>52 days</time_frame>
    <description>The effect of a novel RS3 on gut health: Gut microbiota, short chain fatty acids production, and gut transit will be assessed.&#xD;
To assess metabolites of dietary and microbial origin including short chain fatty acid. Bacterial community structure will be assessed by targeted quantitative polymerase chain reaction (qPCR), high throughput 454 sequencing (Walker et al., ISME J 2010) and 4',6-diamidino-2-phenylindole (DAPI) staining to estimate total bacteria. Gut transit will be assessed once at the end of each diet using a wireless motility device (SmartPill™). Only six volunteers will receive this assessment during the last 5 days of each maintenance period.&#xD;
Questionnaires will be provided to monitor qualitatively gastrointestinal wellbeing during each dietary intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of RS on gut hormones</measure>
    <time_frame>52 days</time_frame>
    <description>Analysis of glucose, insulin, lipid profile and gut peptide will be performed. during the meal test challenge at the end of each dietary intervention (4 times). This will include analysis of Peptide YY (PYY336), Cholecystokinin (CCK), Glucagon-like peptide 1 (GLP1), Ghrelin, and Amylin at 0,30,60,90,120 and 180 minutes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Effect of RS on Appetite subjective sensations</measure>
    <time_frame>52 days</time_frame>
    <description>A 4-questions and 100mm, Visual Analogue Scale (VAS) will be used to measure motivation to eat and appetite e.g. asking questions about hunger, desire to eat, fullness and prospective consumption every hour during awakening hours during 3 days of each phase of the dietary intervention.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Resistant Starch 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resistant Starch Type 3:dose of 26g/day males and 22g/day female during 11 days of the maintenance period. (C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Non- RS3</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-Resistant Starch type 3 food items during 11 days of the maintenance period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistant Starch type 3</intervention_name>
    <description>Resistant Starch 3: 26g/day males for 11 days, 22 g/day females for 11 days</description>
    <arm_group_label>Resistant Starch 3</arm_group_label>
    <other_name>C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
          -  Body Mass Index (BMI) 27-35kg/m2&#xD;
&#xD;
          -  Overall healthy&#xD;
&#xD;
          -  Weight Stable (&lt;3 kg change in the past 4 months, before the trial).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical:&#xD;
&#xD;
          -  Heavy smokers (more than 10 cigarettes/day) or heavy alcohol consumers (more than 4&#xD;
             alcohol units/day for male and more than 3 alcohol units/day for female).&#xD;
&#xD;
          -  Obesity of endocrine origin.&#xD;
&#xD;
          -  Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or&#xD;
             coagulation disease.&#xD;
&#xD;
          -  Gastrointestinal disorders: celiac disease, ulcerative colitis, irritable bowel&#xD;
             syndrome (IBS), Chron's disease, chronic constipation, diverticulitis, history of&#xD;
             gastric bezoar. Suspected strictures, fistulas, or physiological GI obstruction.&#xD;
&#xD;
          -  Psychiatric disorder: severe depression, bulimia, anorexia, schizophrenia, bipolar&#xD;
             disorder.&#xD;
&#xD;
          -  Gastrointestinal procedure or surgery in the past three months.&#xD;
&#xD;
          -  Disorders of swallowing, severe dysphagia to food or pills.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
        Medication exclusion criteria&#xD;
&#xD;
          -  Appetite modulator drugs: orlistat, sibutramine, rimonabant.&#xD;
&#xD;
          -  Mood disorder medications: antidepressants, lithium.&#xD;
&#xD;
          -  Others: oral antidiabetics, insulin, digoxin, thyroid hormones, antibiotics, steroids&#xD;
             or immunosuppressants, recreational substances.&#xD;
&#xD;
          -  Use of implanted or portable electro-mechanical device such as cardiac peacemaker or&#xD;
             infusion pump.&#xD;
&#xD;
          -  Blood donor in the past 3 months.&#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>
  <overall_official>
    <last_name>Dr Alexandra M Johnstone, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rowett Institute of Nutrition and Health. University of Aberdeen</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB219SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.satin-satiety.eu/</url>
    <description>SATIN-EU Consortium web page</description>
  </link>
  <link>
    <url>http://www.abdn.ac.uk/rowett/</url>
    <description>Rowett Institute of Nutrition and Health</description>
  </link>
  <link>
    <url>http://www.abdn.ac.uk/</url>
    <description>The University of Aberdeen</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>March 26, 2015</last_update_submitted>
  <last_update_submitted_qc>March 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Aberdeen</investigator_affiliation>
    <investigator_full_name>P Burns</investigator_full_name>
    <investigator_title>Research Governance Manager R&amp;D University of Aberdeen, NHS Grampian</investigator_title>
  </responsible_party>
  <keyword>Overweight and Obesity</keyword>
  <keyword>Appetite</keyword>
  <keyword>Gut hormones and obesity</keyword>
  <keyword>Resistant Starch</keyword>
  <keyword>Gut microbiota and obesity</keyword>
  <keyword>SmartPill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT01724411
org study id: 2/040/12
secondary id: 289800
secondary id: 2012RW002
nct id: NCT01724411
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: Yes
The proposed study will address the effect of developed novel food products through
      processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability
      and gut health using in vivo studies and validating new in vivo approaches.

      Specifically in this protocol we will address, in a short human intervention study the effect
      of a potentially satiating product on appetite, appetite biomarkers, particularly the
      influence on gut microbiota, tolerance and safety of the products in healthy obese and
      overweight volunteers in free living conditions.
Previous research has suggested that food structure and food composition has a role to play
      in controlling consumption. Low-energy, high-fibre diets provide physical bulk in the
      gastro-intestinal tract to sustain fullness in a way that low-volume, energy-dense foods
      cannot. However, studies shown low long term acceptability be probably associated to its poor
      palatability. Taste and hedonic experience remain the main drivers of consumer choice, and
      the immediate sensory aspect of food products such as palatability to have greater salience
      to consumers than their health promoting properties.

      Changing the properties of foods merely by changing oro-sensory properties and through the
      delay of gastric emptying deals with mechanisms critical to within-meal satiation and early
      post meal satiety and may produce only transient suppression of hunger unless regularly
      consumed and represent benefits in delivering nutritional stimuli to key parts of the
      gastro-intestinal tract. The potential to manufacture change can make food structure variety
      now seem near limitless due the numerous advances in food technology.

      Several recent reports have associated satiety effects with fermentable fibre sources in
      human dietary studies (Nillson et al., 2008, Parnell & Weimer, 2009, Willis et al 2009).
      Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might
      contributes to obesity (Ley et al., 2006, Turnbaugh et al., 2008, Cani et al., 2007).
      However, the different mechanisms involved in lean and obese subjects are not completely
      resolved (Duncan et al., 2008, Schwiertz et al., 2010). Recent evidence in experimental
      animal designs indicates that changes in gut microbiota composition may be associated with
      increased food intake and obesity (Vijay-Kumar et al., 2010) suggesting that satiety and
      intake are influenced by the species composition of the gut microbiota.

      The proposed study will address the effect of developed novel food products through
      processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability
      and gut health using in vivo studies and validating new in vivo approaches. Specifically in
      this protocol we will address the effect of a potentially satiating product on appetite,
      appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of
      the products in healthy obese and overweight volunteers in free living conditions. This study
      is part of the major European project launched in early 2011: SATIN, a collaborative,
      large-scale project that brings together the expertise of 18 participants across Europe to
      develop food products through novel food process that enhance satiety.

      This short-term human nutrition study comprises in a cross-over design testing either a
      potentially satiety product, resistant starch type 3 (RS3) or an equivalent amount
      heterogeneous natural fibre in 24 healthy- obese volunteers, aged 18-65 years old, Body Mass
      Index (BMI) between 27 and 35kg/m2 from both genders after an initial 21 day weight-loss
      programme, in free- living conditions. Dietary intake, body weight, blood pressure would be
      monitored through the study. Faecal, urine and blood samples will be collected to monitor,
      glucose, insulin, gut peptides and assess metabolites of dietary and microbial origin. Gut
      transit will be monitored in six volunteers using a wireless motility device (SmartPill™)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Effect of RS on weight loss
time frame: 52 days
description: During this part of the study the effect of novel fibre (RS3)on weight loss will be assessed after dietary intervention. This will consist of a weight loss plan (21 days) and two maintenance periods (11 days) either with RS3 or no.
Changes in weight, BMI and total and regional body composition information using a two compartment model (fat mass and fat free mass by air displacement densitometry -Bod-Pod) will be assessed at the end of each dietary intervention. Resting Metabolic Rate will be assessed the beginning and at the end of the weight loss diet (Deltatrac).
measure: Effect of RS on gut health
time frame: 52 days
description: The effect of a novel RS3 on gut health: Gut microbiota, short chain fatty acids production, and gut transit will be assessed.
To assess metabolites of dietary and microbial origin including short chain fatty acid. Bacterial community structure will be assessed by targeted quantitative polymerase chain reaction (qPCR), high throughput 454 sequencing (Walker et al., ISME J 2010) and 4',6-diamidino-2-phenylindole (DAPI) staining to estimate total bacteria. Gut transit will be assessed once at the end of each diet using a wireless motility device (SmartPill™). Only six volunteers will receive this assessment during the last 5 days of each maintenance period.
Questionnaires will be provided to monitor qualitatively gastrointestinal wellbeing during each dietary intervention.
measure: Effect of RS on gut hormones
time frame: 52 days
description: Analysis of glucose, insulin, lipid profile and gut peptide will be performed. during the meal test challenge at the end of each dietary intervention (4 times). This will include analysis of Peptide YY (PYY336), Cholecystokinin (CCK), Glucagon-like peptide 1 (GLP1), Ghrelin, and Amylin at 0,30,60,90,120 and 180 minutes.
measure: Effect of RS on Appetite subjective sensations
time frame: 52 days
description: A 4-questions and 100mm, Visual Analogue Scale (VAS) will be used to measure motivation to eat and appetite e.g. asking questions about hunger, desire to eat, fullness and prospective consumption every hour during awakening hours during 3 days of each phase of the dietary intervention.
arm group label: Resistant Starch 3
arm group type: Experimental
description: Resistant Starch Type 3:dose of 26g/day males and 22g/day female during 11 days of the maintenance period. (C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium)
arm group label: Control Non- RS3
arm group type: No Intervention
description: Non-Resistant Starch type 3 food items during 11 days of the maintenance period.
intervention type: Other
intervention name: Resistant Starch type 3
description: Resistant Starch 3: 26g/day males for 11 days, 22 g/day females for 11 days
arm group label: Resistant Starch 3
other name: C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Alexandra M Johnstone, PhD
role: Principal Investigator
affiliation: University of Aberdeen
facility: 
country: United Kingdom
url: http://www.satin-satiety.eu/
description: SATIN-EU Consortium web page
url: http://www.abdn.ac.uk/rowett/
description: Rowett Institute of Nutrition and Health
url: http://www.abdn.ac.uk/
description: The University of Aberdeen
responsible party type: Sponsor-Investigator
investigator affiliation: University of Aberdeen
investigator full name: P Burns
investigator title: Research Governance Manager R&D University of Aberdeen, NHS Grampian
mesh term: Obesity
mesh term: Overweight