Green kiwifruit and Gut Health

Not Applicable

Completed

• Conditions: Constipation; Irritable bowel syndrome with constipation; Oral and Gastrointestinal - Inflammatory bowel disease; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12614000460606
• Lead Sponsor: Zespri International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Healthy group: Adult (18-65 years); BMI 18-35; Generally healthy; Normal bowel habits
Functionally constipated group: 1.Adult (18-65 years); Females will be required to declare stage of menstrual cycle during the different trial phases; BMI between 18-35; Presence of functional constipation according to ROME III diagnostic criteria for functional constipation.

IBS-C group: 1.Adult (18-65 years); Females will be required to declare stage of menstrual cycle during the different trial phases; BMI between 18-35; Presence of functional constipation according to ROME III diagnostic criteria for IBSC.

Exclusion Criteria

Individuals with alarm features associated with bowel habit (recent changes in bowel habit (<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 chord injury, stroke).
All patients will be screened at recruitment for fasting blood glucose. Those with results greater than 7.2 mmol/l will not be accepted into the trial.
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 > 3 months. Similarly those with stable and controlled diabetes (> 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.
Potential participants using laxatives who are not prepared to stop using the laxatives for the 2 week lead-in period will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary measurement of the trial is Complete Spontaneous Bowel Motion frequency (CSBM /week) as a measure of overall bowel function in constipation.<br>The number, or occurrence, of CSBM is recorded by all participants in a daily diary recording bowel habits.<br>A spontaneous bowel movement (SBM) is defined as a stool not induced by rescue medication, whereas a CSBM was defined as an SBM associated with a sensation of complete evacuation<br>[CBSM will be measured daily across the 16 week study]