<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/NCT03257449</url>
  </required_header>
  <id_info>
    <org_study_id>Body Weight Loss Meta</org_study_id>
    <nct_id>NCT03257449</nct_id>
  </id_info>
  <brief_title>Effect of Viscous Soluble Fibres on Body Weight</brief_title>
  <official_title>Effect of Viscous Soluble Fibres on Body Weight Parameters: Review and Meta-analyses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abstract:&#xD;
&#xD;
      Background: Obesity is a global pandemic affects all age groups and is independent risk&#xD;
      factors for most chronic diseases. Dietary intervention is an essential component of obesity&#xD;
      management. Dietary fibre supplements have the potential to facilitate weight reduction based&#xD;
      on their viscosity. Up to date, the evidence of effects of some fibres on weight is&#xD;
      inadequate, and literature provides insufficient information about the effects of the fibre&#xD;
      viscosity in weight management.&#xD;
&#xD;
      Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the&#xD;
      effectiveness of viscous fibres, (agar, alginate, b-glucan from oat and barley, guar gum,&#xD;
      glucomannan, pectin, PGX, psyllium), on body weight reduction.&#xD;
&#xD;
      Methods: Only randomised controlled trials are accepted. The trails must have one of the&#xD;
      selected fibres as a supplement, and the outcomes must have body weight, BMI, waist&#xD;
      circumference, or body fat percentage. Studies shorter than 4 weeks are excluded. Three&#xD;
      databases, (Medline, EMBASE, and Cochrane library), were searched through 04/03/2016.&#xD;
&#xD;
      Results: After removing duplicates, 82 studies will be reviewed in full. Significance: This&#xD;
      meta-analysis is the first meta-analysis that is based on fibre viscosity, and it will&#xD;
      quantify the effect of each fibre in improving weight loss. It will also direct future&#xD;
      research in the best direction to further explore this area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Obesity is a global pandemic and is an independent risk factor for chronic&#xD;
      disease. Dietary intervention is an essential component of obesity management. Observational&#xD;
      studies show an inverse relationship between dietary fibres and body weight. Therefore,&#xD;
      supplements of dietary fibres have the potential to facilitate weight reduction, possibly on&#xD;
      the basis of the viscous properties of the fibre. Viscosity is the ability of gel forming&#xD;
      that holds water and increase satiety and decreases the amount of intake food. This ability&#xD;
      makes dietary fibre supplements considered as appetite suppressants. To date, the evidence of&#xD;
      the effect of dietary fibre on weight is inconsistent and controversial and may be dependent&#xD;
      on the ability of fibre to induce viscosity. Three previous meta-analyses on Konjac show&#xD;
      inconsistency on the effect and its significance. In addition, other meta-analyses on&#xD;
      individual viscous fibres show that some viscous fibre does not has an effect on body weight.&#xD;
      This is the first meta-analysis that studies the effect of all these fibres together based on&#xD;
      their viscosity.&#xD;
&#xD;
      Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the&#xD;
      effect of viscous and non-viscous fibres on body weight, BMI, waist circumference, and body&#xD;
      fat percentage.&#xD;
&#xD;
      Methods: To meet eligibility criteria, the study should be: randomized, controlled, include&#xD;
      one of the selected fibres (agar, alginate, b-glucan from oat and barley, guar gum, konjac,&#xD;
      pectin, PGX, Psyllium, and xanthan) as a supplement and one of the required outcomes (body&#xD;
      weight, BMI, waist circumference or body fat percentage). Studies shorter than 4 weeks in&#xD;
      duration will be excluded. Three databases (Medline, EMBASE, and Cochrane Library) were&#xD;
      searched. After the search, a title/abstract screening was done to exclude the ineligible&#xD;
      articles before extracting data from full eligible studies. Data were extracted using a&#xD;
      PROFORMA. Review Manager 5.3 (RevMan) was used to carry out the analysis using generic&#xD;
      inverse variance method (GIVM). Change from baseline and standard deviation were utilized in&#xD;
      random effect model to get the pooled mean difference effect. Subgroup analyses were done&#xD;
      using meta-regression in STATA to explore confounders. GRADE approach was conducted to&#xD;
      evaluate the quality of evidence and the strength of recommendations.&#xD;
&#xD;
      Results: Databases were searched through 04/03/2016 and updated on 11/04/2017. Twenty-seven&#xD;
      studies were eligible for analyses . The overall effect of viscous fibres on body weight was&#xD;
      a significant reduction of -0.38 kg [95%CI: -0.3, -0.13] (P=0.003). BMI, waist circumference&#xD;
      and body fat were also significantly reduced: -0.41 kg/m2 [95% CI: -0.61, -0.21](p = 0.0001)&#xD;
      -0.78 cm[95%CI: -1.33, -0.24] (p = ) and -1.28 %[95% CI: -2.09, -0.46] (p = ), respectively.&#xD;
&#xD;
      Significance: This study is the first systematic review and meta-analysis that evaluated&#xD;
      separately the effect of viscous and non-viscous fibres on weight in the general population.&#xD;
      The analysis may help guide diet recommendations for obesity and identify the effect of&#xD;
      fibres to direct future research this area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight chang</measure>
    <time_frame>in 4 weeks or more</time_frame>
    <description>unit of measure: Kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI change</measure>
    <time_frame>in 4 weeks or more</time_frame>
    <description>unit of measure: Kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist circumference change</measure>
    <time_frame>in 4 weeks or more</time_frame>
    <description>unit of measure: Cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat percentage change</measure>
    <time_frame>in 4 weeks or more</time_frame>
    <description>unit of measure: %</description>
  </primary_outcome>
  <enrollment type="Anticipated">1268</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>T2DM (Type 2 Diabetes Mellitus)</condition>
  <condition>General Population</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Viscous Fibre</intervention_name>
    <description>Meta-analysis of Randomized Controlled Trials</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study includes all population types.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be a randomized controlled clinical trial with either a parallel or cross-over&#xD;
             design&#xD;
&#xD;
          2. Must have a treatment period of at least 4 week.&#xD;
&#xD;
          3. Healthy children and adults, overweight and obese individuals or individuals with&#xD;
             diabetes were all acceptable&#xD;
&#xD;
          4. Must have one of the selected viscous fibres, (agar, alginate, β-glucan, guar gum,&#xD;
             pectin, polyglycoplex(PGX), Psyllium, Xanthan), as a supplemented treatment.&#xD;
&#xD;
          5. Only β-glucan sources from barley or oat were accepted The amount of barley product or&#xD;
             barley β-glucan must be reported or measured, or must be computable. β-glucan was&#xD;
             considered to be 4.75% in barley, and 3-5% in oat.&#xD;
&#xD;
          6. Must be appropriately controlled.&#xD;
&#xD;
          7. Must measure one of outcomes: body weight, BMI, waist circumference, or Body fat&#xD;
             percentage.&#xD;
&#xD;
          8. These Anthropometry measures can be either primary or secondary outcomes.&#xD;
&#xD;
          9. Enough information must be provided to calculate the magnitude of effect, i.e. end of&#xD;
             treatment measures and/or change from baseline measures&#xD;
&#xD;
         10. Ad lipitum diet only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If the soluble fibre was not one of the selected viscous fibre or a combination.&#xD;
&#xD;
          2. supplement where these fibers could not be isolated each one alone.&#xD;
&#xD;
          3. If the study was insufficiently controlled, i.e. the control was another soluble&#xD;
             fibre.&#xD;
&#xD;
          4. If the outcome measures did not include body weight, BMI, waist circumference, or Body&#xD;
             fat percentage.&#xD;
&#xD;
          5. If the intervention was a diet with no supplemented fibre.&#xD;
&#xD;
          6. If the study provided insufficient information to calculate a magnitude of effect&#xD;
&#xD;
          7. If the study protocol maintains baseline weight.&#xD;
&#xD;
          8. Secondary information such as reviews, editorials, commentaries, were excluded&#xD;
&#xD;
          9. If the diet is hypo-caloric, energy restricted diet, or metabolically controlled diet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nourah Mazhar, MSc (C)</last_name>
    <role>Study Director</role>
    <affiliation>St.Michael Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Body Weight</keyword>
  <keyword>Weight loss</keyword>
  <keyword>BMI</keyword>
  <keyword>Waist Circumference</keyword>
  <keyword>Body Fat Percentage</keyword>
  <keyword>Viscofiber</keyword>
  <keyword>Viscous Fibres</keyword>
  <keyword>supplement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</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/NCT03257449
org study id: Body Weight Loss Meta
nct id: NCT03257449
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Abstract:

      Background: Obesity is a global pandemic affects all age groups and is independent risk
      factors for most chronic diseases. Dietary intervention is an essential component of obesity
      management. Dietary fibre supplements have the potential to facilitate weight reduction based
      on their viscosity. Up to date, the evidence of effects of some fibres on weight is
      inadequate, and literature provides insufficient information about the effects of the fibre
      viscosity in weight management.

      Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the
      effectiveness of viscous fibres, (agar, alginate, b-glucan from oat and barley, guar gum,
      glucomannan, pectin, PGX, psyllium), on body weight reduction.

      Methods: Only randomised controlled trials are accepted. The trails must have one of the
      selected fibres as a supplement, and the outcomes must have body weight, BMI, waist
      circumference, or body fat percentage. Studies shorter than 4 weeks are excluded. Three
      databases, (Medline, EMBASE, and Cochrane library), were searched through 04/03/2016.

      Results: After removing duplicates, 82 studies will be reviewed in full. Significance: This
      meta-analysis is the first meta-analysis that is based on fibre viscosity, and it will
      quantify the effect of each fibre in improving weight loss. It will also direct future
      research in the best direction to further explore this area.
Background: Obesity is a global pandemic and is an independent risk factor for chronic
      disease. Dietary intervention is an essential component of obesity management. Observational
      studies show an inverse relationship between dietary fibres and body weight. Therefore,
      supplements of dietary fibres have the potential to facilitate weight reduction, possibly on
      the basis of the viscous properties of the fibre. Viscosity is the ability of gel forming
      that holds water and increase satiety and decreases the amount of intake food. This ability
      makes dietary fibre supplements considered as appetite suppressants. To date, the evidence of
      the effect of dietary fibre on weight is inconsistent and controversial and may be dependent
      on the ability of fibre to induce viscosity. Three previous meta-analyses on Konjac show
      inconsistency on the effect and its significance. In addition, other meta-analyses on
      individual viscous fibres show that some viscous fibre does not has an effect on body weight.
      This is the first meta-analysis that studies the effect of all these fibres together based on
      their viscosity.

      Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the
      effect of viscous and non-viscous fibres on body weight, BMI, waist circumference, and body
      fat percentage.

      Methods: To meet eligibility criteria, the study should be: randomized, controlled, include
      one of the selected fibres (agar, alginate, b-glucan from oat and barley, guar gum, konjac,
      pectin, PGX, Psyllium, and xanthan) as a supplement and one of the required outcomes (body
      weight, BMI, waist circumference or body fat percentage). Studies shorter than 4 weeks in
      duration will be excluded. Three databases (Medline, EMBASE, and Cochrane Library) were
      searched. After the search, a title/abstract screening was done to exclude the ineligible
      articles before extracting data from full eligible studies. Data were extracted using a
      PROFORMA. Review Manager 5.3 (RevMan) was used to carry out the analysis using generic
      inverse variance method (GIVM). Change from baseline and standard deviation were utilized in
      random effect model to get the pooled mean difference effect. Subgroup analyses were done
      using meta-regression in STATA to explore confounders. GRADE approach was conducted to
      evaluate the quality of evidence and the strength of recommendations.

      Results: Databases were searched through 04/03/2016 and updated on 11/04/2017. Twenty-seven
      studies were eligible for analyses . The overall effect of viscous fibres on body weight was
      a significant reduction of -0.38 kg [95%CI: -0.3, -0.13] (P=0.003). BMI, waist circumference
      and body fat were also significantly reduced: -0.41 kg/m2 [95% CI: -0.61, -0.21](p = 0.0001)
      -0.78 cm[95%CI: -1.33, -0.24] (p = ) and -1.28 %[95% CI: -2.09, -0.46] (p = ), respectively.

      Significance: This study is the first systematic review and meta-analysis that evaluated
      separately the effect of viscous and non-viscous fibres on weight in the general population.
      The analysis may help guide diet recommendations for obesity and identify the effect of
      fibres to direct future research this area.
observational model: Other
time perspective: Prospective
measure: Body weight chang
time frame: in 4 weeks or more
description: unit of measure: Kg
measure: BMI change
time frame: in 4 weeks or more
description: unit of measure: Kg/m2
measure: Waist circumference change
time frame: in 4 weeks or more
description: unit of measure: Cm
measure: Body fat percentage change
time frame: in 4 weeks or more
description: unit of measure: %
intervention type: Dietary Supplement
intervention name: Viscous Fibre
description: Meta-analysis of Randomized Controlled Trials
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nourah Mazhar, MSc (C)
role: Study Director
affiliation: St.Michael Hospital
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight
mesh term: Body Weight