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

This study has been completed.
Sponsor:
Collaborator:
Marigot Ltd.
Information provided by (Responsible Party):
Andrea Doolan, University College Cork
ClinicalTrials.gov Identifier:
NCT01770808
First received: May 14, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Digestive System Disorders
Dietary Supplement: AquaCal
Dietary Supplement: AquaPT
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University College Cork:

Primary Outcome Measures:
  • Change digestive discomfort symptoms at 6 weeks [ Time Frame: wk 0 & wk 6 ] [ Designated as safety issue: No ]
    Global symptom questionnaire


Secondary Outcome Measures:
  • Change abdominal bloating at 6 weeks [ Time Frame: Week 0 & 6 ] [ Designated as safety issue: No ]
    Global symptom questionnaire

  • Change in flatulence at 6 weeks [ Time Frame: Weeks 0 & 6 ] [ Designated as safety issue: No ]
    Global symptom questionnaire

  • Change in tummy discomfort at 6 weeks [ Time Frame: Weeks 0 & 6 ] [ Designated as safety issue: No ]
    Global symptom questionnaire

  • Change in at Cytokines 6 weeks [ Time Frame: Weeks 0 & 6 ] [ Designated as safety issue: No ]
    Plasma cytokines IL6 & IL8


Enrollment: 60
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Dietary Supplement: 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). 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.
Dietary Supplement: AquaPT
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.
Placebo Comparator: Placebo
Produced by Marigot Ltd
Dietary Supplement: Placebo
Subjects swallowed 4 capsules/day for six weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770808

Locations
Ireland
Cork University Hospital
Cork, Ireland
Sponsors and Collaborators
University College Cork
Marigot Ltd.
Investigators
Principal Investigator: Eamonn Quigley, MD University College Cork
  More Information

No publications provided

Responsible Party: Andrea Doolan, Human Studies Manager, University College Cork
ClinicalTrials.gov Identifier: NCT01770808     History of Changes
Other Study ID Numbers: APC027
Study First Received: May 14, 2012
Last Updated: January 17, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Cork:
Bloating
Flatulence
Stomach discomfort

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014