NCT02215785

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

August 12, 2014

Last Update Submit

August 12, 2014

Conditions

Constipation

Keywords

Funtional constipationKiwifruitHealth promotion

Outcome Measures

Primary Outcomes (3)

  • Proportion of patients with three or more stools per week

    Number of patients with three or more stools among participants Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose

    Five weeks

  • Frequency of stool per week

    Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose

    Five weeks

  • Number of responders (increase of ≥ 1 stool per week)

    Number of people increasing more ≥ 1stool for week recorded in a self adminitered questionnaire designed for this purpose

    Five weeks

Secondary Outcomes (4)

  • Consistency of stool

    Five weeks

  • Volume of stool

    Five weeks

  • Ease of defecation

    Five weeks

  • Satisfaction of the patient.

    Five weeks

Study Arms (1)

kiwifruit cohort

EXPERIMENTAL

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

Interventions

KiwifruitOTHER

Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime.

Also known as: Green kiwifruits (Actinidia deliciosa var Hayward)
kiwifruit cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Gol Gurina Foundation

Barcelona, Catalonia, 08007, Spain

Location

MeSH Terms

Conditions

Constipation

Interventions

alcohol acyltransferase, Actinidia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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)

    STUDY CHAIR

  • Mercè Marzo Castillejo,, Dr and Ph.D

    Catalan Institut of Health (ICS) and IDIAP Jordi Gol

    PRINCIPAL INVESTIGATOR

  • 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)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 13, 2014

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

ES(1)