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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Double-blind, Placebo-controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort in Healthy Subjects

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 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. 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.


Sponsor: University College Cork

Current Primary Outcome: Change digestive discomfort symptoms at 6 weeks [ Time Frame: wk 0 & wk 6 ]

Global symptom questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change abdominal bloating at 6 weeks [ Time Frame: Week 0 & 6 ]
    Global symptom questionnaire
  • Change in flatulence at 6 weeks [ Time Frame: Weeks 0 & 6 ]
    Global symptom questionnaire
  • Change in tummy discomfort at 6 weeks [ Time Frame: Weeks 0 & 6 ]
    Global symptom questionnaire
  • Change in at Cytokines 6 weeks [ Time Frame: Weeks 0 & 6 ]
    Plasma cytokines IL6 & IL8


Original Secondary Outcome: Same as current

Information By: University College Cork

Dates:
Date Received: May 14, 2012
Date Started: May 2011
Date Completion:
Last Updated: January 17, 2013
Last Verified: January 2013