None listed
Conditions
Brief summary
The consumption of Kiwifruit has been used to reduce constipation and digestive discomfort in New Zealand for several decades and provides a natural, gentle alternative to pharmacological laxative products. Although clinical trials evaluating the effectiveness of kiwifruit are limited, some have shown significant improvements in digestive health (e.g stool frequency, reduced constipation and general overall well being) in both healthy and constipated individuals as well as those suffering from irritable bowel syndrome (IBS). Actazin(TM) is a dietary supplement/food ingredient from powdered New Zealand kiwifruit which retains the natural bioactive componenents found in the whole fruit to offer a safe, convenient form of kiwifruit for everyday consumption. This study aims to examine the effect of daily consumption of Actazin(TM) in healthy individuals and individuals with IBS as part of their everyday diet and lifestyle to determine if the product is effective at improving bowel regularity, digestive discomfort, digestive health and function and gut health. Participants will be given four different interventions, lasting four weeks each with a two week break in-between. Interventions will consist of Actazin(TM) green standard dose, Actazin(TM) Green high dose, Actazin(TM) gold high dose and placebo. Participants will be asked to consume the supplements daily at breakfast time and to complete a daily study diary (either online or by hand) to record daily bowel movement and general wellbeing. Blood samples will be collected at the beginning and end of the study. Additionally, stool samples will be collected at the beginning and end of each treatment and participants will also be asked to complete two questionnaires relating to bowel health and quality of life at this point (every four week period).
Interventions
Randomised single blind placebo controlled cross- over trial with participants consuming four different treatments for four weeks, with a 2 week wash out in between each treatment. The treatments are as follows:
1. Actazin(TM) (640mg)/ day
2. Actazin(TM) (2400mg)/ day
3. Actazin(TM) Gold. (2400mg)/ day
4. Placebo
Actazin(TM) is a kiwi fruit based food supplement. Treatments will be delivered in 4 capsules which will be formulated to have the same appearance to maintain blinding to treatments
Randomised single blind placebo controlled cross- over trial with participants consuming four different treatments for four weeks, with a 2 week wash out in between each treatment. The treatments are as follows: 1. Actazin(TM) (640mg)/ day 2. Actazin(TM) (2400mg)/ day 3. Actazin(TM) Gold. (2400mg)/ day 4. Placebo Actazin(TM) is a kiwi fruit based food supplement. Treatments will be delivered in 4 capsules which will be formulated to have the same appearance to maintain blinding to treatments. - Placebo = 4 x placebo capsules - 600mg dose = 3 placebo + 1 Actazin(TM) capsule - 2400mg = 4 Actazin(TM) capsules The wash out period of two weeks has been chosen to allow sufficient time to return bowel habit to baseline for the parameters we are measuring (stool frequency, wellbeing questionnaires and microbial ecology). Venous blood samples will be collected at the beginning and end of the study for baseline biochemical analysis. For each day from baseline until the end of the study the participants will record their symptoms including stool frequency, form and associated symptoms in a study diary provided by the investigators. At the beginning and end of each four week intervention period, participants will be asked to provide a faecal sample and complete a GR-IBS questionnaire as well as an IBS-specific Quality of Life (QoL) questionnaire relating to wellness. Participants will also be asked to complete a 3 day food diary at the beginning and end of the trial to assess individual’s normal dietary intake
Sponsors
Stratum Nutrition
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Aged 18 – 55 years (to avoid age groups where possible undiagnosed cancer may start to be an issue). BMI limits between 19 and 30 k/m2. Fasting blood glucose under 5.6mmol /L. Subjects will be required to be willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity pattern throughout the study period. Subjects will be asked to exclude high fibre supplements such as Metamucil (Registered Trademark), Benefibre (Registered Trademark) and Phloe(TM) as well as refraining from eating fresh kiwifruit for the study period. Participants will also have to avoid overseas travel for the period of the study due to the impact this may have on diet.
Exclusion criteria
Presence of gastrointestinal alarm symptoms (including blood in stools, frequent diarrhoea, unremitting abdominal pain) Dieters or people who are following vegan, raw food diets or very high fibre diets Gastroparesis or lactose intolerance Surgery for weight loss (lapband or gastric bypass) Pregnant women Clinically significant renal, hepatic, endocrine, cardiac, pulmonary, pancreatic, neurological, hematologic or biliary disorders Known allergy or sensitivity to kiwifruit
Outcome results
None listed