None listed
Conditions
Brief summary
Our hypothesis is that using the whole fruit (including skin) of SunGold kiwifruit will affect the production of the cytokines IL6 and TNFalpha that are chemicals released into the blood that may increase inflammation that results in unfavorable gastrointestinal symptoms individuals with IBS –C. It is hypothesized that SunGold kiwifruit will help reduce the production of these chemicals and provide greater relief of gastrointestinal symptoms associated with this condition. A randomised cross over study. A total of 40 individuals will be recruited. 20 participants in the healthy group and 20 participants in the irritable bowel syndrome with constipation group. Participants will be randomised to consume 3 SunGold kiwifruit minus the skin or 3 SunGold kiwifruit plus the skin daily for 4 weeks. They will then have a four week washout before commencing on 4 weeks of the other treatment. The trial will begin with a two week lead in period and finish with a two week washout. Blood samples will be taken for Chem 20 panel, Cytokine (TNFa, IL6) and CRP. Participants will be asked to complete GSRS and Birmingham IBS questionnaire at the beginning of the study and the end of each treatment phase. Stool frequency, form and associated symptoms will be recorded in a daily dairy throughout the trial. Three day diet record will be collected at the beginning and end of each treatment phase. Endpoints will be changes in the levels of pro inflammatory cytokines, changes in stool frequency and improvement in GI wellbeing. Stool form, GSRS and Birmingham IBS symptom questionnaire , HBA1c levels will be secondary endpoints.
Interventions
A randomised cross over study. A total of 40 individuals will be recruited. 20 participants in the healthy group and 20 participants in the irritable bowel syndrome with constipation group. Participants will be randomised to consume 3 SunGold kiwifruit minus the skin or 3 SunGold kiwifruit plus the skin daily for 4 weeks. The kiwifruit will be in addition to their usual daily diet. They will then have a four week washout before commencing on 4 weeks of the other treatment. The trial will begin
A randomised cross over study. A total of 40 individuals will be recruited. 20 participants in the healthy group and 20 participants in the irritable bowel syndrome with constipation group. Participants will be randomised to consume 3 SunGold kiwifruit minus the skin or 3 SunGold kiwifruit plus the skin daily for 4 weeks. The kiwifruit will be in addition to their usual daily diet. They will then have a four week washout before commencing on 4 weeks of the other treatment. The trial will begin with a two week lead in period and finish with a two week washout. Blood samples will be taken for Chem 20 panel, Cytokine (TNFa, IL6) and CRP at baseline as an indication of overall health and to ensure that the eligibility criteria are met. Chem 20 and CRP measurements are not an outcome of the study. Participants will be asked to complete GSRS and Birmingham IBS questionnaire at the beginning of the study and the end of each treatment phase. Stool frequency, form and associated symptoms will be recorded in a daily diary throughout the trial. Three day diet record will be collected at the beginning and end of each treatment phase. The intervention will be administered by a registered nutritionist with over 30 years experience in science and research. Participants will be seen in individual sessions where treatments will be administered and discussions held around the trial and questionnaires that are required to be filled in during the study. Visits will be for up to 1 hour in duration and will occur at each time point throughout the study (Baseline, two weeks, six weeks, ten weeks, 14 weeks and 16 weeks. The study visits will be held at a clinical trial facility in central Christchurch, NZ. All kiwifruit will be delivered to each participants home/work address on a weekly basis during the duration of the study interventions. Compliance with the study product will be self- monitored by filling in the questions of the the daily diary but participants will be asked at each clinic visit about compliance with the product.
Sponsors
The New Zealand Institute for Plant and Food Research Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participants a. Adult (18-65 years) b. BMI 18-35 kgm2 c. Generally healthy d. Normal bowel habits IBS-C participants a. Adult (18-65 years) b. BMI 18-35 kgm2 c. Meet the criteria for IBS-C as described by the Rome III criteria Participants with IBS-C (mild). The diagnostic criteria * for Irritable Bowel Syndrome is: Recurrent abdominal pain or discomfort** at least 3 days per month in the last 3 months associated with 2 or more of the following: i. Improvement with defecation ii. Onset associated with a change in frequency of stool iii. Onset associated with a change in form (appearance of stool) * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis ** Discomfort means an uncomfortable sensation not described as pain. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation for subject eligibility. IBS-C requires meeting the IBS criteria together with – hard or lumpy stools (Bristol Stool Form Scale 1-2) greater than or equal to 25%, and loose or mushy stools greater than or equal to 25% of bowel movements (Bristol Stool Form Scale 6-7).
Exclusion criteria
Potential participants will be excluded if they have any alarm features associated with bowel habit (recent changes in bowel habit (less than 3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD. Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal cord injury, stroke). All patients will be screened at recruitment for fasting blood glucose. Those with results greater than or equal to 6.1 mmol/l will not be accepted into the trial as they are at risk of having impaired glucose tolerance, which is an exclusion criteria for the study. Participants with diagnosed and stable conditions requiring the use of SSRI’s (selective serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be permitted into the trial on condition the medication has been in use continually and the condition has been stable for greater than 3 months. Similarly those with stable and controlled diabetes (greater than 3 months) will be permitted to participate. Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded. Potential participants with known kiwifruit or latex allergy will be excluded. The reason for excluding latex allergy is because people with this allergy are more likely to have an allergy to food including kiwifruit. Potential participants using laxatives who are not prepared to stop using the laxatives for the study will be excluded.
Outcome results
None listed