Efficacy of ActiPhen™ on gastrointestinal tract function in otherwise healthy adults. A randomised double blind placebo-controlled study.
RDC Global Pty Ltd
90 participants
Nov 15, 2018
Interventional
Conditions
Summary
The aim of this study is to evaluate the effect of ActiPhen,™ a kiwi fruit powder extract, on gastrointestinal tract function (including bowel movements, abdominal pain, intestinal permeability) in healthy adults over 6 weeks. It is hypothesised ActiPhen™ will enhance gastrointestinal tract function (including bowel movements, abdominal pain, intestinal permeability) and increase quality of life compared to placebo.
Eligibility
Inclusion Criteria7
- Males and females aged over 18 years
- Females using a prescribed form of birth control (e.g. oral contraceptive)
- Experiencing three or more of the following symptoms of gastrointestinal discomfort including bloating, flatulence, diarrhoea, constipation, reflux, heart burn, abdominal pain/discomfort experienced at least 3 days in the last month
- Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2 month period of self-reported dietary stability.
- Agree to not change current diet or exercise regime during entire study period
- Agree to not use any other dietary supplements or digestive enzymes during the study period
- Able to provide informed consent
Exclusion Criteria21
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland
- function Malignancy)
- People with a past or current history of inflammatory bowel disease or gastrointestinal tract
- surgery
- Pregnant or breastfeeding mothers
- Malignancy or treatment for malignancy within the previous 2 years
- Receiving/ prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other
- anticoagulation therapy including low dose aspirin
- Active smokers, nicotine, alcohol, drug abuse
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- Any history of kiwi fruit allergy
- Those suffering from insomnia or have night-shift employment and unable to have a normal
- night’s sleep
- People suffering any neurological disorders such as MS
- Any condition which in the opinion of the investigator makes the participant unsuitable for
- inclusion (including hypercholesterolemia)
- Participants who have participated in any other clinical trial during the past 3 months
- Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
- History of infection in the month prior to the study or taking antibiotic therapy
- Hydration therapy during study period
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Interventions
Approximately 90 adult male and female participants aged over 18 years will be recruited from databases and public media outlets. Participants will take the allocated product daily for 6 weeks attend the study site at week 3 and week 6 for progress assessments. Consenting participants will undergo a health assessment including lifestyle, current medications, weight and height assessment, GIT function (questionnaire), quality of life (fatigue) and medical history. Blood lutein, serotonin and zonulin concentration and MPOD will also be measured. As Kiwi fruit is a known source of Lutein, both plasma lutein and macula pigment density will be measured to assess if ActiPhen™ can supplement lutein concentration in the plasma and in turn increase macular pigment in the eye. Participants will be allocated 1 of 3 products in capsule form and the capsules are to be taken orally at breakfast time with food and 250mL water. The 3 products are as per the below: 1. ActiPhen™ 1000mg dose (over 6 capsules) 2. ActiPhen™ 3000mg dose (over 6 capsules) 3. Placebo – 4300mg maltodextrin (over 6 capsules)
Locations(1)
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ACTRN12618000875202