The Effect of Consumption of Kiwifruit on Constipation in Adults

• ClinicalTrials.gov Identifier: NCT02215785
• Recruitment Status: Completed
• First Posted: August 13, 2014
• Last Update Posted: August 13, 2014
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Information provided by (Responsible Party): Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Tracking Information

• First Submitted Date: August 12, 2014
• First Posted Date: August 13, 2014
• Last Update Posted Date: August 13, 2014
• Study Start Date: April 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 12, 2014)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 12, 2014)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Consumption of Kiwifruit on Constipation in Adults
• Official Title: Improvement of Functional Constipation With Kiwifruit Intake in a Mediterranean Patient Population: Open Non-controlled and Non-randomized Longitudinal Study

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.

Detailed Description

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).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Constipation

Intervention

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)

Study Arms

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.

Intervention: Other: Kiwifruit

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 12, 2014): 46
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02215785
• Other Study ID Numbers: 4R13/055
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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)

• PRS Account: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Verification Date: August 2014