None listed
Conditions
Brief summary
The aim of this study is to determine the effect of encapsulated kiwifruit extract on bowel habits, gut comfort, change in faecal microbiota, and quality of life in men and women with self-reported constipation, but otherwise healthy. This will be a 2 treatment, double blind, randomised, crossover trial, comparing the active treatment, NZ Extracts encapsulated kiwifruit extract, with a matched placebo. Each treatment will be administered for a 3 week period, separated by a minimum 3 week washout period. The total trial length will be between 9-15 weeks; allowing for a maximum washout period of 9 weeks.
Interventions
The intervention is an encapsulated kiwifruit extract, extracted via a water extraction process from Actinidia deliciosa (from both the skin and flesh). It contains an excipient maltodextrin. The daily dosage will be 1,000mg (2 x 500mg; morning and evening) taken orally with food. This will be taken for a period of 21 days.
A washout period will take place inbetween the intervention (21day) blocks. The washout period will be a minimum of 3 weeks and a maximum of 9 weeks. The washout period
The intervention is an encapsulated kiwifruit extract, extracted via a water extraction process from Actinidia deliciosa (from both the skin and flesh). It contains an excipient maltodextrin. The daily dosage will be 1,000mg (2 x 500mg; morning and evening) taken orally with food. This will be taken for a period of 21 days. A washout period will take place inbetween the intervention (21day) blocks. The washout period will be a minimum of 3 weeks and a maximum of 9 weeks. The washout period will be determined by the participant and when they are able to complete each leg of the study over the study. Capsule count for complience assessment will conducted after 21days. Telephone follow up at 1week and 2week of treatment. Daily assessment of bowel habits by participant self report diary. Capsules will be labelled A or B (treatment or placebo) by NZ Extracts Ltd. Arm One - Treatment A or Treatment B Arm Two - Washout period (break) minimum of 3 weeks and maximum of 9 weeks Arm Three - Treatment A or Treatment B (crossover)
Sponsors
New Zealand Extracts Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Self reported as healthy Male/Female 20-65 yrs Suffer constipation and bowel discomfort
Exclusion criteria
Significant GI disease including IBD, Crohn’s disease, ulcerative colitis, coeliac disease, or inflammatory or malabsorptive condition
Outcome results
None listed