Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2002
Date assigned
16/12/2002
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cliona Ni Mhurchu

ORCID ID

Contact details

Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
-
New Zealand
+64 (0)9 373 7599 ext 84494
c.nimhurchu@ctru.auckland.ac.nz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HRC 01/416

Study information

Scientific title

Acronym

ECHO

Study hypothesis

Results from trials of chitosan as a weight loss treatment have provided conflicting results. A 1998 review of 5 studies suggested that chitosan was an effective treatment for overweight and obesity. However, many more chitosan trials have been carried out since then with variable results. In order resolve the uncertainty surrounding the effectiveness of this dietary supplement, we conducted a large randomised controlled clinical trial of the effect of chitosan on body weight, lipids, and other health outcomes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Obesity

Intervention

3 g Chitosan daily versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Chitosan

Primary outcome measures

The primary aim of the ECHO study was to determine if chitosan was an effective weight loss treatment for people who were overweight or obese.

Measures included changes in body weight (kilograms); body mass index, waist circumference; body fat percentage; systolic and diastolic blood pressure; serum cholesterol and lipids; plasma glucose; fat-soluble vitamins; faecal fat losses and health-related quality of life, from baseline to 24 weeks.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Overweight/obese male or female volunteers
2. Aged greater than 18 years
3. Body Mass Index (BMI) between 28 - 50 kg/m^2

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

250

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2001

Recruitment end date

30/06/2003

Locations

Countries of recruitment

New Zealand

Trial participating centre

Clinical Trials Research Unit
Auckland
-
New Zealand

Sponsor information

Organisation

Health Research Council of New Zealand (New Zealand)

Sponsor details

PO Box 5541
Wellesley Street
Auckland
1001
New Zealand
+64 (0)9 379 8227
bscoggins@hrc.govt.nz

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

The Health Research Council of New Zealand (New Zealand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Healtheries of New Zealand Ltd (New Zealand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15311218
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15608806
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15655037

Publication citations

  1. Mhurchu CN, Poppitt SD, McGill AT, Leahy FE, Bennett DA, Lin RB, Ormrod D, Ward L, Strik C, Rodgers A, The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults., Int. J. Obes. Relat. Metab. Disord., 2004, 28, 9, 1149-1156, doi: 10.1038/sj.ijo.0802693.

  2. Ni Mhurchu C, Bennett D, Lin R, Hackett M, Jull A, Rodgers A, Obesity and health-related quality of life: results from a weight loss trial., N. Z. Med. J., 2004, 117, 1207, U1211.

  3. Mhurchu CN, Dunshea-Mooij C, Bennett D, Rodgers A, Effect of chitosan on weight loss in overweight and obese individuals: a systematic review of randomized controlled trials., Obes Rev, 2005, 6, 1, 35-42, doi: 10.1111/j.1467-789X.2005.00158.x.

Additional files

Editorial Notes