The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions

NCT02888392 | Completed

• 1 other identifier: HN1525
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Secondary measures will show the consumption of kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with IBS-C.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Complete Spontaneous Bowel Motions

  A spontaneous bowel motion not induced by rescue medication and associated with a sense of complete evacuation

  Total study duration per participant of 16 weeks. CSBM was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .

Secondary Outcomes (7)

• Daily Bowel Habit

  Total study duration per participant of 16 weeks. Daily bowel habit was assessed daily from 2 week lead-in before baseline and every day through intervention 1, wash-out, intervention 2 and for a two week follow-up period .

• Weekly Gastrointestinal Symptom Rating Scale (GSRS)

  Total study duration per participant of 16 weeks. GSRS was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .

• Rome III

  Total study duration per participant of 16 weeks. Rome III was assessed at the start of the study, 2 weeks later at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .

• Irritable Bowel Syndrome Quality of Life (IBS-QoL) evaluation

  Total study duration per participant of 16 weeks. Rome III was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and the end of intervention 2.

• Profile of Mood Score (POMS)

  Total study duration per participant of 16 weeks. POMS was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .

Study Arms (2)

Kiwifruit intervention

EXPERIMENTAL

4 week intervention treatment with 2 fresh, whole green kiwifruit per day

Other: Kiwifruit

Psyllium intervention

ACTIVE COMPARATOR

4 week intervention treatment with psyllium, matched for fibre content of 2 green kiwifruit / day for 4 weeks

Dietary Supplement: Psyllium

Interventions

Kiwifruit OTHER

2 green kiwifruit cultivar 'Hayward'

Kiwifruit intervention

Psyllium DIETARY_SUPPLEMENT

Pysllium seed husk; ispaghula, isabgol, or psyllium, are portions of the seeds of the plant Plantago ovata, (genus Plantago), a native of India, Bangladesh and Pakistan. They are hygroscopic, which allows them to expand and become mucilaginous. Psyllium is a faecal bulking agent used to treat constipation. It absorbs liquid in the intestines, swells and forms a bulky soft stool that is easy to pass

Also known as: Ispaghula, isabgol

Psyllium intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The functionally constipated (FC) study participant group will be selected based on the following criteria:
• Presence of functional constipation according to ROME III diagnostic criteria\*5b i. Must include 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 evacuation, support of pelvic floor)
• Fewer than three defecations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome \* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
• Participants with IBS-C (mild). The diagnostic criteria \* for Irritable Bowel Syndrome5a 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) ≥ 25%, and loose or mushy stools ≤ 25% of bowel movements (Bristol Stool Form Scale 6-7).

You may not qualify if:

• Potential participants will be excluded if they have any 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 ≥ 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.

Sponsors & Collaborators

• Zespri International Limited: lead

Study Sites (1)

St. Orsola Hospital

Bologna, Italy

Location

Related Publications (1)

• Gearry R, Fukudo S, Barbara G, Kuhn-Sherlock B, Ansell J, Blatchford P, Eady S, Wallace A, Butts C, Cremon C, Barbaro MR, Pagano I, Okawa Y, Muratubaki T, Okamoto T, Fuda M, Endo Y, Kano M, Kanazawa M, Nakaya N, Nakaya K, Drummond L. Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort-Results of an International Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2023 Jun 1;118(6):1058-1068. doi: 10.14309/ajg.0000000000002124. Epub 2022 Dec 20.

  PMID: 36537785 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

alcohol acyltransferase, Actinidia; Psyllium

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Giovanni Barbara, MD

  St. Orsola Hospital, University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 5, 2016
• Study Start: December 18, 2015
• Primary Completion: January 30, 2017
• Study Completion: January 30, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

IT (1)