None listed
Conditions
Brief summary
The aims of this study are to determine whether a 4-week, daily supplementation of a New Zealand kiwifruit supplement product (Actazin®) can change bowel habits in free-living adults with functional constipation over baseline (day 0) values. It is a randomised crossover placebo-controlled double-blind study. The study duration is 14 weeks; 4-week lead-in period for acclimatisation and baseline measurements, followed by a 4-week intervention period, a 2-week washout period, followed by another 4-week intervention period. Participants will be recruited from social media advertising (e.g. Facebook). The aims of the study and investigational product will be described, along with descriptions of the questionnaires and demographic data sought. It is hoped that people with functional constipation but otherwise healthy will volunteer to participate. Following confirmation of participation, receipt of informed consent, self-assessed meeting of the inclusion/exclusion criteria and appropriateness of volunteered data, participants will be sent to consume daily, for 4 weeks, a capsule of placebo containing maltodextrin to acclimatise themselves to the study and its questionnaires. After this 4 week lead-in period they will be send for the first 4-week intervention period either a capsule of 600 mg Actazin on an empty stomach 1 h before a meal, or placebo containing coloured, flavoured maltodextrin, and asked to continue to volunteer appropriate questionnaire reports on their bowel habits and stool form. After 4 weeks, participants will have a 2 week washout period on placebo, followed by another 4-week intervention period where they will be sent to consume daily , either a capsule of 600 mg Actazin on an empty stomach 1 h before a meal or placebo containing coloured, flavoured maltodextrin, and continue to volunteer appropriate questionnaire reports on their bowel habits and stool form. At baseline (day 0) and endpoint (day 28) of each intervention, participants will complete questionnaires to assess their quality of life and constipation symptoms. No biological samples will be taken from participants expressly for the purposes of this study.
Interventions
There is a 28 day lead-in period where participants will consume 1 x inactive placebo (maltodextrin) 600 mg capsule prior to the first intervention period.
Then participants will enter their first randomly allocated intervention period, comprising either 1 x Actazin 600 mg capsule intervention product or 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal, for 28 days.
The first intervention phase will be followed by a 14 day washout phase in
There is a 28 day lead-in period where participants will consume 1 x inactive placebo (maltodextrin) 600 mg capsule prior to the first intervention period. Then participants will enter their first randomly allocated intervention period, comprising either 1 x Actazin 600 mg capsule intervention product or 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal, for 28 days. The first intervention phase will be followed by a 14 day washout phase in between intervention periods, where they will consume 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal. Finally, participants will enter their second randomly allocated intervention period, comprising either 1 x Actazin 600 mg capsule intervention product or 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal, for 28 days. Compliance will be assessed by the participants returning all capsule containers in an addressed, postage-paid courier bag for a capsule usage count.
Sponsors
Anagenix Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria: a. They are an adult aged 18-65 b. They have functional constipation assessed as equal to or greater than two of the following: i. Straining (for more than 25% of defecations) ii. Lumpy of hard stools scoring 1 or 2 on Bristol Stool Score (for greater than 25% of defecations) iii. Sensation of incomplete evacuations (for greater than 25% of defecations) iv. Sensation of anorectal obstruction/blockage (for greater than 25% of defecations) v. Manual manoeuvres to facilitate defecation, e.g. digital evacuation, pelvic floor support (for greater than 25% of defecations) vi. Less than 3 spontaneous bowel movements per week. c. They are on stable medication for at least 4 weeks prior to recruitment, and unlikely to change medication during the course of this study d. They are not currently participating in another clinical interventional study e. They are not currently pregnant or lactating. f. They will provide written informed consent g. They agree to avoid eating kiwifruit or other kiwifruit-derived products for the duration of the study.
Exclusion criteria
Participants with at least one of the following criteria will be excluded: a. Current or prior (previous six months) antibiotic treatment b. Current or prior eating disorder (e.g. anorexia nervosa, bulimia) that would interfere with consumption and/or absorption of the investigational product c. Current viral hepatitis (type A, B or C), liver cirrhosis, chronic kidney disease, heart failure, thyroid disease or cancer. d. Food allergy or intolerance that would compromise compliance with the study protocol, including kiwifruit, or latex allergy e. Prior gastrointestinal surgery (e.g. cholecystectomy, gastric lap band or gastric bypass), not including appendicitis or caesarean section. f. Gastrointestinal alarm symptoms including rectal bleeding, weight loss, blood in stools, frequent diarrhoea, and unremitting abdominal pain, and major diseases of the gastrointestinal tract (such as IBS, Crohn’s disease, celiac disease, ulcerative colitis, malignant tumour of the colon, etc.), pulmonary or endocrine systems, or other GI abnormalities.
Outcome results
None listed