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A Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort

Primary Purpose

Digestive System Disorders

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
AquaCal
AquaPT
Placebo
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive System Disorders focused on measuring Bloating, Flatulence, Stomach discomfort

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

  1. Be able to give written informed consent.
  2. Be a female between 18 and 65 years of age.
  3. Be a non-pregnant female.
  4. Be in generally good health as determined by the investigator.
  5. Have no evidence of gastrointestinal disease or of a functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
  6. 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;

  1. Are less than 18 and greater than 65 years of age.
  2. Are pregnant females.
  3. Are currently taking probiotics, vitamin supplements or plant sterols ester supplements or have taken them in the past 14 days.
  4. Have received a diagnosis or attending a doctor for Irritable Bowel Syndrome or a functional bowel disorder.
  5. Experience bloating, flatulence and stomach discomfort greater that 2 times/week, over the last 3 months.
  6. 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).
  7. Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding.
  8. 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.
  9. Be a smoker
  10. Suffer from alcohol abuse.
  11. Suffer from psychiatric disease.
  12. Subjects are lactose intolerant or have dietary habits (slimming or vegetarian diet) which could interfere with the assessment of the study product.
  13. 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.
  14. Subjects may not be receiving treatment involving experimental drugs.
  15. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
  16. Have a malignant disease or any concomitant end-stage organ disease

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AquaCal

AquaPT

Placebo

Arm Description

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).

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.

Produced by Marigot Ltd

Outcomes

Primary Outcome Measures

Change digestive discomfort symptoms at 6 weeks
Global symptom questionnaire

Secondary Outcome Measures

Change abdominal bloating at 6 weeks
Global symptom questionnaire
Change in flatulence at 6 weeks
Global symptom questionnaire
Change in tummy discomfort at 6 weeks
Global symptom questionnaire
Change in at Cytokines 6 weeks
Plasma cytokines IL6 & IL8

Full Information

First Posted
May 14, 2012
Last Updated
January 17, 2013
Sponsor
University College Cork
Collaborators
Marigot Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01770808
Brief Title
A Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort
Official Title
A Randomised, Double-blind, Placebo-controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork
Collaborators
Marigot Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disorders
Keywords
Bloating, Flatulence, Stomach discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AquaCal
Arm Type
Experimental
Arm Description
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).
Arm Title
AquaPT
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Produced by Marigot Ltd
Intervention Type
Dietary Supplement
Intervention Name(s)
AquaCal
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AquaPT
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects swallowed 4 capsules/day for six weeks.
Primary Outcome Measure Information:
Title
Change digestive discomfort symptoms at 6 weeks
Description
Global symptom questionnaire
Time Frame
wk 0 & wk 6
Secondary Outcome Measure Information:
Title
Change abdominal bloating at 6 weeks
Description
Global symptom questionnaire
Time Frame
Week 0 & 6
Title
Change in flatulence at 6 weeks
Description
Global symptom questionnaire
Time Frame
Weeks 0 & 6
Title
Change in tummy discomfort at 6 weeks
Description
Global symptom questionnaire
Time Frame
Weeks 0 & 6
Title
Change in at Cytokines 6 weeks
Description
Plasma cytokines IL6 & IL8
Time Frame
Weeks 0 & 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eamonn Quigley, MD
Organizational Affiliation
University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland

12. IPD Sharing Statement

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A Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort

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