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

NCT01770808 | Completed DMC

• 1 other identifier: APC027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive System Disorders

Keywords

Bloating; Flatulence; Stomach discomfort

Outcome Measures

Primary Outcomes (1)

• Change digestive discomfort symptoms at 6 weeks

  Global symptom questionnaire

  wk 0 & wk 6

Secondary Outcomes (4)

• Change abdominal bloating at 6 weeks

  Week 0 & 6

• Change in flatulence at 6 weeks

  Weeks 0 & 6

• Change in tummy discomfort at 6 weeks

  Weeks 0 & 6

• Change in at Cytokines 6 weeks

  Weeks 0 & 6

Study Arms (3)

AquaCal

EXPERIMENTAL

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

AquaPT

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Produced by Marigot Ltd

Dietary Supplement: Placebo

Interventions

AquaCal DIETARY_SUPPLEMENT

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.

AquaCal

AquaPT DIETARY_SUPPLEMENT

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.

AquaPT

Placebo DIETARY_SUPPLEMENT

Subjects swallowed 4 capsules/day for six weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead
• Marigot Ltd.: collaborator

Study Sites (1)

Cork University Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Digestive System Diseases; Flatulence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eamonn Quigley, MD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Human Studies Manager

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: January 18, 2013
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

IE (1)