- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770808
A Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort
A Randomised, Double-blind, Placebo-controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort in Healthy Subjects
Digestive discomfort includes gastrointestinal symptoms such as abdominal pain, altered bowel habit, flatulence and bloating and can sometimes result from slower intestinal transit and other digestive irregularities.
The objective of this study is to investigate the effect of consuming Aquamin (as AquaCal and AquaPT) on digestive discomfort and symptoms amongst adults without diagnosed gastrointestinal disorders.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Digestive discomfort includes gastrointestinal symptoms such as abdominal pain, altered bowel habit, flatulence and bloating and can sometimes result from slower intestinal transit and other digestive irregularities. Digestive discomfort may lead to health issues in the long-term. In a recent survey of over 1,000 women in the UK, 88% reported having experienced digestive discomfort from time to time, but the majority of them (70%) had never consulted a doctor or nurse. Digestive discomfort is often a source of embarrassment for people; they therefore may be reluctant to address these issues with a healthcare professional.
Aquamin is a seaweed-derived mineral source, which is rich in calcium, magnesium and 74 other trace minerals including zinc, iron and selenium. It is produced from the red algae, Lithothamnion Calcareum, which is found in just three locations in the world, including the south-west coast of Ireland and Iceland. During a five-year life span, these algae absorb essential minerals from the sea - this gives Aquamin its unique multimineral content. The algae then break down naturally and settle on the sea bed. These calcified skeletal remains are harvested, washed, dried and milled and provided in a capsule formulation. Aquamin is proven to deliver digestive health benefits. In a recent study, mice feed on a high-fat 'Western-style' diet (HFWD) and Aquamin, suppressed colon polyp formation and a reduction in systemic inflammatory changes in comparison to those not receiving Aquamin.
The objective of this study is to investigate the effect of consuming Aquamin (as AquaCal and AquaPT) on digestive discomfort and symptoms amongst adults without diagnosed gastrointestinal disorders.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cork, Ireland
- Cork University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must;
- Be able to give written informed consent.
- Be a female between 18 and 65 years of age.
- Be a non-pregnant female.
- Be in generally good health as determined by the investigator.
- Have no evidence of gastrointestinal disease or of a functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
- Experience occasional bloating and stomach discomfort, defined as 1-2 times/weeks, but not greater that 2 times/week over the last 3 months.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
- Are less than 18 and greater than 65 years of age.
- Are pregnant females.
- Are currently taking probiotics, vitamin supplements or plant sterols ester supplements or have taken them in the past 14 days.
- Have received a diagnosis or attending a doctor for Irritable Bowel Syndrome or a functional bowel disorder.
- Experience bloating, flatulence and stomach discomfort greater that 2 times/week, over the last 3 months.
- Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study).
- Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding.
- Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include anti-inflammatory drugs, corticosteroids, laxatives, enemas, antibiotics (within 1 month), probiotics, anti-coagulants, vitamin supplements and over-the counter non-steroidal analgesics.
- Be a smoker
- Suffer from alcohol abuse.
- Suffer from psychiatric disease.
- Subjects are lactose intolerant or have dietary habits (slimming or vegetarian diet) which could interfere with the assessment of the study product.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- Subjects may not be receiving treatment involving experimental drugs.
- If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
- Have a malignant disease or any concomitant end-stage organ disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AquaCal
AquaCal is produced by Marigot Ltd.
The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg).
|
AquaCal is produced by Marigot Ltd.
The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg).
Subjects swallowed 4 capsules/day for six weeks.
|
Experimental: AquaPT
AquaPT are produced by Marigot Ltd.
The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract.
|
AquaPT is produced by Marigot Ltd according to EU and FDA requirements.
The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract.
Subjects swallowed 4 capsules/day for six weeks.
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Placebo Comparator: Placebo
Produced by Marigot Ltd
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Subjects swallowed 4 capsules/day for six weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change digestive discomfort symptoms at 6 weeks
Time Frame: wk 0 & wk 6
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Global symptom questionnaire
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wk 0 & wk 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change abdominal bloating at 6 weeks
Time Frame: Week 0 & 6
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Global symptom questionnaire
|
Week 0 & 6
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Change in flatulence at 6 weeks
Time Frame: Weeks 0 & 6
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Global symptom questionnaire
|
Weeks 0 & 6
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Change in tummy discomfort at 6 weeks
Time Frame: Weeks 0 & 6
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Global symptom questionnaire
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Weeks 0 & 6
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Change in at Cytokines 6 weeks
Time Frame: Weeks 0 & 6
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Plasma cytokines IL6 & IL8
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Weeks 0 & 6
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eamonn Quigley, MD, University College Cork
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APC027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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