<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/NCT02215785</url>
  </required_header>
  <id_info>
    <org_study_id>4R13/055</org_study_id>
    <nct_id>NCT02215785</nct_id>
  </id_info>
  <brief_title>The Effect of Consumption of Kiwifruit on Constipation in Adults</brief_title>
  <official_title>Improvement of Functional Constipation With Kiwifruit Intake in a Mediterranean Patient Population: Open Non-controlled and Non-randomized Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Constipation is a symptom suffered by a large number of people, due to multifactorial causes.&#xD;
      Some studies have proven that modifying lifestyle reduces the risk of constipation, with&#xD;
      high-fibre diets being less prone to constipation. Kiwifruit consumption, improves functional&#xD;
      constipation and some studies consistently report an increase in the frequency and ease of&#xD;
      defecation, stool volume and softness.&#xD;
&#xD;
      Although literature suggests kiwifruit consumption improves constipation symptoms, no studies&#xD;
      have been carried out in adults and in Mediterranean patient populations, characteristic for&#xD;
      its differential nutritional habits. The aim of the present study was to test the effect of&#xD;
      kiwifruit consumption on functional constipation in a Spanish adult population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Worldwide general population prevalence of constipation ranges from 0.7% to 79% (median 16%).&#xD;
      Some factors associated with constipation are sex, with higher prevalence in females&#xD;
      (especially during pregnancy, and age; in general it becomes gradually more prevalent after&#xD;
      the 70 years of age, in women the increase is considerable from a young age (18-23 years old)&#xD;
      to middle age (45-50 years old).&#xD;
&#xD;
      Constipation is characterized by difficult or infrequent deposition, often accompanied by&#xD;
      excessive straining during bowel movement or sensation of incomplete evacuation. In most&#xD;
      cases, there is no underlying organic cause, and constipation is labelled as chronic&#xD;
      idiopathic constipation and as a functional digestive disorder. The Rome III criteria is a&#xD;
      useful tool for the diagnosis of constipation that highlights the chronic nature of the&#xD;
      disorder and the importance of symptoms beyond the infrequency of bowel movements.&#xD;
&#xD;
      Understanding its causes, prevention, and treatment will help most people find constipation&#xD;
      relief. An individual's medical history is very important in determining a constipation&#xD;
      diagnosis. Primary healthcare professionals should enquire about dietary habits and&#xD;
      lifestyle, pharmacological and toxic habits, complementary and alternative medicine,&#xD;
      physiological bowel habits, use of laxatives and past disease history&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      To test the effect of kiwifruit consumption on functional constipation in a Spanish adult&#xD;
      population&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Design :Open non-controlled and non-randomized longitudinal study, of the effect of kiwifruit&#xD;
      consumption in adult patients with diagnosed constipation&#xD;
&#xD;
      Setting: The study was conducted in five primary healthcare centres in Barcelona, Catalonia,&#xD;
      Spain.&#xD;
&#xD;
      Period Study: Between April and August 2013&#xD;
&#xD;
      Population: Fifteen participating Primary Care Professionals selected patients from the&#xD;
      electronic medical records (e-HCAP) following inclusion and exclusion criteria. Each&#xD;
      professional could include a maximum of 4 patients. Forty-six subjects were selected for the&#xD;
      study&#xD;
&#xD;
      Sample size: It was calculated to detect a change in the proportion of individuals with 3 or&#xD;
      more defecations per week from 56% to 86% (evolution from an average of 3.2 to 4.4 -stable&#xD;
      Standard Deviation (SD) of 1.3- in a normal distribution). Assuming a bilateral contrast for&#xD;
      paired data, with a significance level of 0.05 and power of 0.8, a sample of 44 individuals&#xD;
      was required (covering a 10% of dropout rate).&#xD;
&#xD;
      Intervention: The duration of the study was five weeks. During the first two weeks no&#xD;
      kiwifruit patients were asked to follow their normal diet. The next three weeks they were&#xD;
      asked to consume three Zespri green kiwifruits (Actinidia deliciosa var Hayward) per day, one&#xD;
      at each main meal (breakfast, lunch and dinner). Throughout the five-week study period the&#xD;
      patient had to continue their normal eating habits and exercise regime.&#xD;
&#xD;
      Tools and instructions: Primary Care Professionals asked patients to participate in the study&#xD;
      and explained it to them. Patients who voluntarily agreed to participate signed the informed&#xD;
      consent, accepting all study procedures. Each participant in the study attended three&#xD;
      consultations: the first one before starting the study, the second one after two weeks and&#xD;
      the third one after five weeks.&#xD;
&#xD;
      To collect the information patients used a questionnaire designed for this purpose. His/her&#xD;
      Primary Care Professional provided instructions on the recording of faecal characteristics.&#xD;
      The French original version of the diary was translated into Spanish and Catalan. Patients&#xD;
      chose their own language to respond. Professionals collected data from diaries in a Google&#xD;
      Docs form.&#xD;
&#xD;
      Patients were supplied kiwifruits in a heterogeneous manner. Some patients in the study&#xD;
      bought the prescribed product. In other cases it was the professional who provided the&#xD;
      kiwifruits. In one of the Primary Care Centres, the neighbourhood shopkeeper was the&#xD;
      responsible for delivering the kiwifruits to the patients. Patients who bought their own&#xD;
      Zespri kiwifruit were refunded.&#xD;
&#xD;
      Statistical analysis: Demographics for patients were summarized calculating medians&#xD;
      [InterQuartile Range (IQR)] for continuous variables and proportions for categorical&#xD;
      variables. Categorical variables were compared from baseline (second week) to last week using&#xD;
      the Bhapkar test. For some analyses, Facility and Volume categorical variables were treated&#xD;
      as continuous in order to provide results easy to interpret and taking into account&#xD;
      individuals' correlations; in these cases, one unit of gain should be interpreted as an&#xD;
      improvement in one response category. Functional data methodology was used for some graphical&#xD;
      representations. Stacked barplots over time will be presented for categorical variables. To&#xD;
      analyse week changes in daily variables Generalized Estimating Equation (GEE) models were&#xD;
      adjusted (treating variables as continuous).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with three or more stools per week</measure>
    <time_frame>Five weeks</time_frame>
    <description>Number of patients with three or more stools among participants Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of stool per week</measure>
    <time_frame>Five weeks</time_frame>
    <description>Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of responders (increase of ≥ 1 stool per week)</measure>
    <time_frame>Five weeks</time_frame>
    <description>Number of people increasing more ≥ 1stool for week recorded in a self adminitered questionnaire designed for this purpose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consistency of stool</measure>
    <time_frame>Five weeks</time_frame>
    <description>Bristol Scale: classified as Type 1 (Separate hard lumps, like nuts -hard to pass), Type 2 (Sausage-shaped, but lumpy), Type 3 (Like a sausage but with cracks on its surface), Type 4 (Like a sausage or snake, smooth and soft), Type 5 (Soft blobs with clear cut edges -passed easily-), Type 6 (Fluffy pieces with ragged edges, a mushy stool), or Type 7 (Watery, no solid pieces. Entirely liquid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of stool</measure>
    <time_frame>Five weeks</time_frame>
    <description>Classified as: very little (1), little (2), medium (3), reasonably much (4), a lot (5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of defecation</measure>
    <time_frame>Five weeks</time_frame>
    <description>Classified as: very easy (1), easy (2), normal (3), difficult (4), very difficult (5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the patient.</measure>
    <time_frame>Five weeks</time_frame>
    <description>Patients answer eight questions related to the improvement of defecation habits and quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>kiwifruit cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients that presented at Primary Care Centres with registered -Roma III criteria based- constipation and who accepted to participate in the study were followed-up for two weeks before intervention and three weeks under 3-daily kiwifruit intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kiwifruit</intervention_name>
    <description>Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime.</description>
    <arm_group_label>kiwifruit cohort</arm_group_label>
    <other_name>Green kiwifruits (Actinidia deliciosa var Hayward)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Two or more of the following:&#xD;
&#xD;
        Straining during at least 25% of defecations Lumpy or hard stools in at least 25% of&#xD;
        defecations Sensation of incomplete evacuation for at least 25% of defecations Sensation of&#xD;
        anorectal obstruction/blockage for at least 25% of defecations Manual manoeuvres to&#xD;
        facilitate at least 25% of defecations (e.g., digital evacuations and support of the pelvic&#xD;
        floor) Fewer than three defecations per week; and&#xD;
&#xD;
          -  Loose stools are rarely present without the use of laxatives;&#xD;
&#xD;
          -  Insufficient criteria for irritable bowel syndrome;&#xD;
&#xD;
          -  Criteria fulfilled for at least 3 months with symptom onset at least 6 months before&#xD;
             diagnosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with allergy to kiwifruit or latex&#xD;
&#xD;
          -  Patients who have undergone gastro-intestinal surgery in the last year&#xD;
&#xD;
          -  Patients taking medication to treat constipation&#xD;
&#xD;
          -  Patients with oncological disease&#xD;
&#xD;
          -  Patients taking narcotic medication&#xD;
&#xD;
          -  Patients with organic gastroenterological diseases (except non- complicated&#xD;
             diverticulosis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta Besa Castellà, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institute of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Berlanga López</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institute of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Caterina Calvet Torres, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M Àngeles Cisneros Antó</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Judith Company Fontané</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosa Ma Clofent Vilaplana, Dr and Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Caridad Delgado López, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institu of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ma Isabel Denche Naranjo</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maite Escudero Ruiz</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela Ferreres Castell</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sonia Fuentes Rodriguez, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amparo Gallart Iglesias</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M Roser Garriga Bacardí, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabel Marin Quilez</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mercè Marzo Castillejo,, Dr and Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catalan Institut of Health (ICS) and IDIAP Jordi Gol</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juanjo Mascort Roca, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Ollé Mitjans, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vanesa Pérez Martín</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesca Peñas López, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gemma Nerin Pueyo</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosa Ramírez Torralbo, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mercedes Rodriguez Pascual</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Ruipérez Martín</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josefa Ruiz Tejero</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sonia Varela Folgueiras</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carmen Vela Vallespín, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mercè Vilarrubi Estrella, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ivan Villar Balboa, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Catalan Institut of Health (ICS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jordi Gol Gurina Foundation</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Funtional constipation</keyword>
  <keyword>Kiwifruit</keyword>
  <keyword>Health promotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT02215785
org study id: 4R13/055
nct id: NCT02215785
lead sponsor: 
has dmc: No
Constipation is a symptom suffered by a large number of people, due to multifactorial causes.
      Some studies have proven that modifying lifestyle reduces the risk of constipation, with
      high-fibre diets being less prone to constipation. Kiwifruit consumption, improves functional
      constipation and some studies consistently report an increase in the frequency and ease of
      defecation, stool volume and softness.

      Although literature suggests kiwifruit consumption improves constipation symptoms, no studies
      have been carried out in adults and in Mediterranean patient populations, characteristic for
      its differential nutritional habits. The aim of the present study was to test the effect of
      kiwifruit consumption on functional constipation in a Spanish adult population.
Worldwide general population prevalence of constipation ranges from 0.7% to 79% (median 16%).
      Some factors associated with constipation are sex, with higher prevalence in females
      (especially during pregnancy, and age; in general it becomes gradually more prevalent after
      the 70 years of age, in women the increase is considerable from a young age (18-23 years old)
      to middle age (45-50 years old).

      Constipation is characterized by difficult or infrequent deposition, often accompanied by
      excessive straining during bowel movement or sensation of incomplete evacuation. In most
      cases, there is no underlying organic cause, and constipation is labelled as chronic
      idiopathic constipation and as a functional digestive disorder. The Rome III criteria is a
      useful tool for the diagnosis of constipation that highlights the chronic nature of the
      disorder and the importance of symptoms beyond the infrequency of bowel movements.

      Understanding its causes, prevention, and treatment will help most people find constipation
      relief. An individual's medical history is very important in determining a constipation
      diagnosis. Primary healthcare professionals should enquire about dietary habits and
      lifestyle, pharmacological and toxic habits, complementary and alternative medicine,
      physiological bowel habits, use of laxatives and past disease history

      Aims:

      To test the effect of kiwifruit consumption on functional constipation in a Spanish adult
      population

      Methods:

      Design :Open non-controlled and non-randomized longitudinal study, of the effect of kiwifruit
      consumption in adult patients with diagnosed constipation

      Setting: The study was conducted in five primary healthcare centres in Barcelona, Catalonia,
      Spain.

      Period Study: Between April and August 2013

      Population: Fifteen participating Primary Care Professionals selected patients from the
      electronic medical records (e-HCAP) following inclusion and exclusion criteria. Each
      professional could include a maximum of 4 patients. Forty-six subjects were selected for the
      study

      Sample size: It was calculated to detect a change in the proportion of individuals with 3 or
      more defecations per week from 56% to 86% (evolution from an average of 3.2 to 4.4 -stable
      Standard Deviation (SD) of 1.3- in a normal distribution). Assuming a bilateral contrast for
      paired data, with a significance level of 0.05 and power of 0.8, a sample of 44 individuals
      was required (covering a 10% of dropout rate).

      Intervention: The duration of the study was five weeks. During the first two weeks no
      kiwifruit patients were asked to follow their normal diet. The next three weeks they were
      asked to consume three Zespri green kiwifruits (Actinidia deliciosa var Hayward) per day, one
      at each main meal (breakfast, lunch and dinner). Throughout the five-week study period the
      patient had to continue their normal eating habits and exercise regime.

      Tools and instructions: Primary Care Professionals asked patients to participate in the study
      and explained it to them. Patients who voluntarily agreed to participate signed the informed
      consent, accepting all study procedures. Each participant in the study attended three
      consultations: the first one before starting the study, the second one after two weeks and
      the third one after five weeks.

      To collect the information patients used a questionnaire designed for this purpose. His/her
      Primary Care Professional provided instructions on the recording of faecal characteristics.
      The French original version of the diary was translated into Spanish and Catalan. Patients
      chose their own language to respond. Professionals collected data from diaries in a Google
      Docs form.

      Patients were supplied kiwifruits in a heterogeneous manner. Some patients in the study
      bought the prescribed product. In other cases it was the professional who provided the
      kiwifruits. In one of the Primary Care Centres, the neighbourhood shopkeeper was the
      responsible for delivering the kiwifruits to the patients. Patients who bought their own
      Zespri kiwifruit were refunded.

      Statistical analysis: Demographics for patients were summarized calculating medians
      [InterQuartile Range (IQR)] for continuous variables and proportions for categorical
      variables. Categorical variables were compared from baseline (second week) to last week using
      the Bhapkar test. For some analyses, Facility and Volume categorical variables were treated
      as continuous in order to provide results easy to interpret and taking into account
      individuals' correlations; in these cases, one unit of gain should be interpreted as an
      improvement in one response category. Functional data methodology was used for some graphical
      representations. Stacked barplots over time will be presented for categorical variables. To
      analyse week changes in daily variables Generalized Estimating Equation (GEE) models were
      adjusted (treating variables as continuous).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of patients with three or more stools per week
time frame: Five weeks
description: Number of patients with three or more stools among participants Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose
measure: Frequency of stool per week
time frame: Five weeks
description: Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose
measure: Number of responders (increase of ≥ 1 stool per week)
time frame: Five weeks
description: Number of people increasing more ≥ 1stool for week recorded in a self adminitered questionnaire designed for this purpose
measure: Consistency of stool
time frame: Five weeks
description: Bristol Scale: classified as Type 1 (Separate hard lumps, like nuts -hard to pass), Type 2 (Sausage-shaped, but lumpy), Type 3 (Like a sausage but with cracks on its surface), Type 4 (Like a sausage or snake, smooth and soft), Type 5 (Soft blobs with clear cut edges -passed easily-), Type 6 (Fluffy pieces with ragged edges, a mushy stool), or Type 7 (Watery, no solid pieces. Entirely liquid).
measure: Volume of stool
time frame: Five weeks
description: Classified as: very little (1), little (2), medium (3), reasonably much (4), a lot (5).
measure: Ease of defecation
time frame: Five weeks
description: Classified as: very easy (1), easy (2), normal (3), difficult (4), very difficult (5).
measure: Satisfaction of the patient.
time frame: Five weeks
description: Patients answer eight questions related to the improvement of defecation habits and quality of life.
arm group label: kiwifruit cohort
arm group type: Experimental
description: Patients that presented at Primary Care Centres with registered -Roma III criteria based- constipation and who accepted to participate in the study were followed-up for two weeks before intervention and three weeks under 3-daily kiwifruit intake.
intervention type: Other
intervention name: Kiwifruit
description: Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime.
arm group label: kiwifruit cohort
other name: Green kiwifruits (Actinidia deliciosa var Hayward)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Marta Besa Castellà, Dr
role: Study Chair
affiliation: Catalan Institute of Health (ICS)
last name: Francisco Berlanga López
role: Study Chair
affiliation: Catalan Institute of Health (ICS)
last name: Caterina Calvet Torres, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: M Àngeles Cisneros Antó
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Judith Company Fontané
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Rosa Ma Clofent Vilaplana, Dr and Ph.D
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Caridad Delgado López, Dr
role: Study Chair
affiliation: Catalan Institu of Health (ICS)
last name: Ma Isabel Denche Naranjo
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Maite Escudero Ruiz
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Angela Ferreres Castell
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Sonia Fuentes Rodriguez, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Amparo Gallart Iglesias
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: M Roser Garriga Bacardí, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Isabel Marin Quilez
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Mercè Marzo Castillejo,, Dr and Ph.D
role: Principal Investigator
affiliation: Catalan Institut of Health (ICS) and IDIAP Jordi Gol
last name: Juanjo Mascort Roca, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Maria Ollé Mitjans, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Vanesa Pérez Martín
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Francesca Peñas López, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Gemma Nerin Pueyo
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Rosa Ramírez Torralbo, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Mercedes Rodriguez Pascual
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Laura Ruipérez Martín
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Josefa Ruiz Tejero
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Sonia Varela Folgueiras
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Carmen Vela Vallespín, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Mercè Vilarrubi Estrella, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
last name: Ivan Villar Balboa, Dr
role: Study Chair
affiliation: Catalan Institut of Health (ICS)
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Constipation