Condition category
Digestive System
Date applied
13/01/2015
Date assigned
28/01/2015
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Manucol LD is an alginate which comes from seaweed. Eating seaweeds is good for you. People in Asia who eat lots of it have less chance of developing certain disease such as bowel cancer and inflammatory bowel disease. Seaweeds are essentially a fibre and this product that is extracted from it (the alginate) is used throughout the food industry in products such as ice creams, sauces and jams, and in a number of medicines such as Gaviscon. The active ingredient in seaweed is not accurately known, however alginates are thought to play a key role in its beneficial effects. Through scientific research, it has been found that these alginates can bind iron and other heavy metals and are not broken down by digestive processes in the gut. It is also known that iron which is unabsorbed can have negative effects on the bowel such as inflammation and changes in the levels of good and bad bacteria in the gut. The researchers carrying out this study are interested in using a form of alginate which is altered for delivery to the human colon. This alginate can bind iron in the colon and so reduce the damaging effects of this highly reactive metal. Here, the effect of various doses of alginates in normal healthy people are studied with a view to taking this forward in patients with inflammatory bowel disease or those at risk of developing bowel cancer. This alginate is found in a range of foods and therefore safe for consumption. This study will test this foodstuff at a higher concentrations to see if it is acceptable and easy to consume on a daily basis.

Who can participate?
The study aims to recruit 16 healthy male or female volunteers over the age of 18 years through advertising at the University of Birmingham and the University Hospitals of Birmingham.

What does the study involve?
Participants are asked to attend 3 visits over a 1 month period. Participants are requested to take the Manucol LD on a daily basis, keep a record of when it is taken and if there are any changes in their bowel habit e.g. frequency. At each of these 3 visits they are asked to provide a stool sample (to assess the levels of good and bad bacteria), have blood tests (as markers of general health) and fill in a quality of life questionnaire.

What are the potential benefits and risks of participating?
There will be no direct benefit to individuals taking part in the study. As the Manucol LD is essentially a foodstuff and found in a number of products on the market no problems are anticipated. However as it is a fibre it may cause some bloating and change to participants’ bowel habit. The disadvantages of taking part are the inconvenience entailed in adhering to study protocol and visit schedule. Another drawback is the minor discomfort associated with the two blood tests at the beginning, middle and end of the study.

Where is the study run from?
University of Birmingham in collaboration with the Wellcome Trust Clinical Research Facility at the Queen Elizabeth Hospital in Birmingham (UK)

When is the study starting and how long is it expected to run for?
October 2014 to August 2015

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
1. Dr Chris Tselepis (scientific)
c.tselepis@bham.ac.uk
2. Dr Tariq Iqbal (public)
t.h.iqbal@bham.ac.uk
3. Mr Pritesh Mistry (public)
p.mistry.1@bham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Tariq Iqbal

ORCID ID

Contact details

School of Cancer Sciences
Vincent Drive
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
07713 575156
t.h.iqbal@bham.ac.uk

Type

Scientific

Additional contact

Dr Chris Tselepis

ORCID ID

Contact details

School of Cancer Sciences
Vincent Drive
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0) 121 414 2972
c.tselepis@bham.ac.uk

Type

Public

Additional contact

Mr Pritesh Mistry

ORCID ID

http://orcid.org/0000-0002-7066-0472

Contact details

School of Cancer Sciences
Vincent Drive
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
0121 414 2228
p.mistry.1@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

A physiological study to assess the acceptability of daily alginate (Manucol LD) consumption in healthy volunteers

Acronym

ALENCOL

Study hypothesis

Consuming a daily alginate (Manucol LD) is acceptable

Ethics approval

NRES Committee West Midlands - Edgbaston, 20/08/2015, ref: 15/WM/0221

Study design

Prospective single-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

This physiological study aims to look at the acceptability of consuming a daily alginate which is thought to improve colonic health.

Intervention

Objectives
1. To evaluate the acceptability of supplementation of Manucol LD in healthy subjects for 28 days.
2. To explore the benefit of Manucol LD on bifidobacteria.

Participants take Manucol LD daily for 28 days. They keep a record of when it is taken and if there are any changes in bowel habit. They attend the study centre 3 times over this period where they provide stool and blood samples and complete a quality of life questionnaire..

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

General acceptability of Manucol LD by the end of the study period.

Secondary outcome measures

1. Effect of Manucol LD on quality of life measured over the 1 month period using the SF36 questionnaire
2. Level of bifidobacteria (a bacterium associated with gut health) in stool

Overall trial start date

06/10/2014

Overall trial end date

03/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy male or female participants aged 18 years or above
2. In the opinion of the investigator, capable of complying with the study requirements and completing the study
3. Willing and able to give informed consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

16

Participant exclusion criteria

Participants who have a current or previous history of gastrointestinal disease will not be eligible to take part in the study.

Recruitment start date

01/04/2015

Recruitment end date

01/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Wellcome Trust
1st Floor Wellcome Trust Building (Blue Zone) Old Queen Elizabeth Hospital Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
0121 414 7618
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.