ConstipationNCT02215785
The Effect of Consumption of Kiwifruit on Constipation in Adults
A study testing Kiwifruit in people with Constipation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- Kiwifruit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Functional Constipation With Kiwifruit Intake in a Mediterranean Patient Population: Open Non-controlled and Non-randomized Longitudinal Study
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.
Read the 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).
- Conditions
- Constipation
- Being tested
- Kiwifruit
- Keywords
- Funtional constipation, Kiwifruit, Health promotion
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KiwifruitOther
Also called Green kiwifruits (Actinidia deliciosa var Hayward)
Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kiwifruit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Five weeks
Frequency of stool per week
Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose
Measured: 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
Measured: Five weeks
Secondary outcomes (4)
Consistency of stool
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).
Measured: Five weeks
Volume of stool
Classified as: very little (1), little (2), medium (3), reasonably much (4), a lot (5).
Measured: Five weeks
Ease of defecation
Classified as: very easy (1), easy (2), normal (3), difficult (4), very difficult (5).
Measured: Five weeks
Satisfaction of the patient.
Patients answer eight questions related to the improvement of defecation habits and quality of life.
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Besa Castellà, Dr, Study chair, Catalan Institute of Health (ICS)Francisco Berlanga López, Study chair, Catalan Institute of Health (ICS)Caterina Calvet Torres, Dr, Study chair, Catalan Institut of Health (ICS)M Àngeles Cisneros Antó, Study chair, Catalan Institut of Health (ICS)Judith Company Fontané, Study chair, Catalan Institut of Health (ICS)Rosa Ma Clofent Vilaplana, Dr and Ph.D, Study chair, Catalan Institut of Health (ICS)Caridad Delgado López, Dr, Study chair, Catalan Institu of Health (ICS)Ma Isabel Denche Naranjo, Study chair, Catalan Institut of Health (ICS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215785
- Sponsor's protocol ID
- 4R13/055
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Functional Constipation With Kiwifruit Intake in a Mediterranean Patient Population: Open Non-controlled and Non-randomized Longitudinal Study
- ClinicalTrials.gov ID
- NCT02215785
- Acronym / sponsor ID
- 4R13/055
- Conditions
- Constipation
- Keywords
- Funtional constipation, Kiwifruit, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kiwifruit cohort | Experimental | Other: KiwifruitPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KiwifruitAlso: Green kiwifruits (Actinidia deliciosa var Hayward)Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime. | Other | kiwifruit cohort |
Primary outcome
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
4 secondary outcomes
Consistency of stool
Time frame: Five weeks
Volume of stool
Time frame: Five weeks
Ease of defecation
Time frame: Five weeks
Satisfaction of the patient.
Time frame: Five weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Besa Castellà, Dr study chair
Catalan Institute of Health (ICS)
Francisco Berlanga López study chair
Catalan Institute of Health (ICS)
Caterina Calvet Torres, Dr study chair
Catalan Institut of Health (ICS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kiwifruit in people with Constipation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with three or more stools per week (time frame: Five weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.