None listed
Conditions
Brief summary
The proposed study will be a randomised, controlled, cross-over clinical intervention study. The cross-over design will be completed using the kiwifruit intervention of two green kiwifruit per day, compared to a positive control intervention of psyllium (2.5 teaspoons of Metamucil® per day providing 5.0 g fibre to match that fibre content of two green kiwifruit), and the combination of kiwifruit and psyllium (1 green kiwifruit per day and 1.25 teaspoons of Metamucil per day providing a total of 5.0 g of fibre). The study duration is a total of 17 weeks; 2-week lead in, 3-week intervention, 2-week washout, 3-week intervention, 2-week washout, 3-week intervention and final 2-week follow-up. 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 (spontaneous bowel movements (SBM), complete bowel movements (CBM) bowel movements (BM)), and habitual dietary fibre intake.
Interventions
This is a 17-week cross-over study. Participants will consume three treatments; 2 kiwifruit daily, one kiwifruit plus 1.25 tsp of Metamucil® daily or 2.5 tsp of Metamucil® daily. There is two week lead-in period, a three week intervention, a two week wash-out, a second three week intervention, a two week wash-out, a third three week intervention and a two week follow-up period. Venous blood samples (20 ml) will be collected at the beginning and end of the study. Bowel health and dietary intake w
This is a 17-week cross-over study. Participants will consume three treatments; 2 kiwifruit daily, one kiwifruit plus 1.25 tsp of Metamucil® daily or 2.5 tsp of Metamucil® daily. There is two week lead-in period, a three week intervention, a two week wash-out, a second three week intervention, a two week wash-out, a third three week intervention and a two week follow-up period. Venous blood samples (20 ml) will be collected at the beginning and end of the study. Bowel health and dietary intake will be assessed using faecal samples and three-day diet records. A daily bowel habit diary will be completed for 11 weeks of the trial. The trial involves 8 visits to Plant & Food Research. At the end of each trial period, participants will return unused kiwifruit or Metamucil® to the trial coordinators as a measure of compliance. Particpants will also be directly asked whether or not they adhered to the protocol.
Sponsors
Plant and Food Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults between ages of 18-65 years inclusive with a BMI between 18-35 kg/m2.
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 cord injury, stroke). All participants will be screened at recruitment for fasting blood glucose. Those with results great than or equal to 6.0 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 the condition that the medication has been in use continually and that 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. The reason for excluding latex allergy is because people with this allergy are more likely to have an allergy to food including kiwifruit.
Outcome results
None listed