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

NCT ID: NCT02888392

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-18
• Study Completion Date: 2017-01-30

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.

Detailed Description

The study is a randomised, single-blinded, cross-over design. Both target study populations (those with functional constipation, and the matched healthy control group) will complete the 16-week trial. Each study group will be randomly selected to either begin the first intervention period on the kiwifruit treatment or the psyllium treatment, and following the washout period will then receive the opposite treatment. Researchers and analysts will be blind as to as to the order of treatment individuals will receive. A dedicated treatment administrator will be assigned to provide the treatments to participants and liaise with them during the intervention phases.

All participants will be free living and required to maintain their normal dietary and lifestyle habits for the duration of the trial.

The primary outcome measure will be quantification of CSBM (complete spontaneous bowel movement). Secondary outcome measures will include additional stool frequency measures and other questionnaires.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Kiwifruit intervention

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

Group Type: EXPERIMENTAL

Kiwifruit

Intervention Type: OTHER

2 green kiwifruit cultivar 'Hayward'

Psyllium intervention

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

Group Type: ACTIVE_COMPARATOR

Psyllium

Intervention Type: 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

Interventions

Kiwifruit

2 green kiwifruit cultivar 'Hayward'

Intervention Type: OTHER

Psyllium

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ispaghula, isabgol

Eligibility Criteria

Inclusion Criteria

• The functionally constipated (FC) study participant group will be selected based on the following criteria:

1. Presence of functional constipation according to ROME III diagnostic criteria*5b i. Must include two or more of the following:

1. Straining during at least 25% of defecations

2. Lumpy or hard stools in at least 25% of defecations

3. Sensation of incomplete evacuation for at least 25% of defecations

4. Sensation of anorectal obstruction/blockage for at least 25% of defecations

5. Manual manoeuvres to facilitate at least 25% of defecations (e.g. digital evacuation, support of pelvic floor)

6. 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

2. 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zespri International Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Barbara, MD

Role: PRINCIPAL_INVESTIGATOR

St. Orsola Hospital, University of Bologna

Locations

St. Orsola Hospital

Bologna, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36537785 (View on PubMed)

Other Identifiers

HN1525

Identifier Type: -

Identifier Source: org_study_id