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The Effect of Consumption of Kiwifruit on Constipation in Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02215785
First Posted: August 13, 2014
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
  Purpose

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.


Condition Intervention
Constipation Other: Kiwifruit

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improvement of Functional Constipation With Kiwifruit Intake in a Mediterranean Patient Population: Open Non-controlled and Non-randomized Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Proportion of patients with three or more stools per week [ Time Frame: Five weeks ]
    Number of patients with three or more stools among participants Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose

  • Frequency of stool per week [ Time Frame: Five weeks ]
    Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose

  • Number of responders (increase of ≥ 1 stool per week) [ Time Frame: Five weeks ]
    Number of people increasing more ≥ 1stool for week recorded in a self adminitered questionnaire designed for this purpose


Secondary Outcome Measures:
  • Consistency of stool [ Time Frame: Five weeks ]
    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).

  • Volume of stool [ Time Frame: Five weeks ]
    Classified as: very little (1), little (2), medium (3), reasonably much (4), a lot (5).

  • Ease of defecation [ Time Frame: Five weeks ]
    Classified as: very easy (1), easy (2), normal (3), difficult (4), very difficult (5).

  • Satisfaction of the patient. [ Time Frame: Five weeks ]
    Patients answer eight questions related to the improvement of defecation habits and quality of life.


Enrollment: 46
Study Start Date: April 2013
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: kiwifruit cohort
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.
Other: Kiwifruit
Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime.
Other Name: Green kiwifruits (Actinidia deliciosa var Hayward)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two or more of the following:

Straining during at least 25% of defecations Lumpy or hard stools in at least 25% of defecations Sensation of incomplete evacuation for at least 25% of defecations Sensation of anorectal obstruction/blockage for at least 25% of defecations Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital evacuations and support of the pelvic floor) Fewer than three defecations per week; and

  • Loose stools are rarely present without the use of laxatives;
  • Insufficient criteria for irritable bowel syndrome;
  • Criteria fulfilled for at least 3 months with symptom onset at least 6 months before diagnosis.

Exclusion Criteria:

  • Patients with allergy to kiwifruit or latex
  • Patients who have undergone gastro-intestinal surgery in the last year
  • Patients taking medication to treat constipation
  • Patients with oncological disease
  • Patients taking narcotic medication
  • Patients with organic gastroenterological diseases (except non- complicated diverticulosis).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215785


Locations
Spain
Jordi Gol Gurina Foundation
Barcelona, Catalonia, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Study Chair: Marta Besa Castellà, Dr Catalan Institute of Health (ICS)
Study Chair: Francisco Berlanga López Catalan Institute of Health (ICS)
Study Chair: Caterina Calvet Torres, Dr Catalan Institut of Health (ICS)
Study Chair: M Àngeles Cisneros Antó Catalan Institut of Health (ICS)
Study Chair: Judith Company Fontané Catalan Institut of Health (ICS)
Study Chair: Rosa Ma Clofent Vilaplana, Dr and Ph.D Catalan Institut of Health (ICS)
Study Chair: Caridad Delgado López, Dr Catalan Institu of Health (ICS)
Study Chair: Ma Isabel Denche Naranjo Catalan Institut of Health (ICS)
Study Chair: Maite Escudero Ruiz Catalan Institut of Health (ICS)
Study Chair: Angela Ferreres Castell Catalan Institut of Health (ICS)
Study Chair: Sonia Fuentes Rodriguez, Dr Catalan Institut of Health (ICS)
Study Chair: Amparo Gallart Iglesias Catalan Institut of Health (ICS)
Study Chair: M Roser Garriga Bacardí, Dr Catalan Institut of Health (ICS)
Study Chair: Isabel Marin Quilez Catalan Institut of Health (ICS)
Principal Investigator: Mercè Marzo Castillejo,, Dr and Ph.D Catalan Institut of Health (ICS) and IDIAP Jordi Gol
Study Chair: Juanjo Mascort Roca, Dr Catalan Institut of Health (ICS)
Study Chair: Maria Ollé Mitjans, Dr Catalan Institut of Health (ICS)
Study Chair: Vanesa Pérez Martín Catalan Institut of Health (ICS)
Study Chair: Francesca Peñas López, Dr Catalan Institut of Health (ICS)
Study Chair: Gemma Nerin Pueyo Catalan Institut of Health (ICS)
Study Chair: Rosa Ramírez Torralbo, Dr Catalan Institut of Health (ICS)
Study Chair: Mercedes Rodriguez Pascual Catalan Institut of Health (ICS)
Study Chair: Laura Ruipérez Martín Catalan Institut of Health (ICS)
Study Chair: Josefa Ruiz Tejero Catalan Institut of Health (ICS)
Study Chair: Sonia Varela Folgueiras Catalan Institut of Health (ICS)
Study Chair: Carmen Vela Vallespín, Dr Catalan Institut of Health (ICS)
Study Chair: Mercè Vilarrubi Estrella, Dr Catalan Institut of Health (ICS)
Study Chair: Ivan Villar Balboa, Dr Catalan Institut of Health (ICS)
  More Information

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02215785     History of Changes
Other Study ID Numbers: 4R13/055
First Submitted: August 12, 2014
First Posted: August 13, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by Jordi Gol i Gurina Foundation:
Funtional constipation
Kiwifruit
Health promotion

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms