Effect of Chitosan on Health and Obesity

ISRCTN	ISRCTN96702062
DOI	https://doi.org/10.1186/ISRCTN96702062
Secondary identifying numbers	HRC 01/416

Submission date: 16/12/2002
Registration date: 16/12/2002
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Cliona Ni Mhurchu
Scientific

Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
-
New Zealand

Phone	+64 (0)9 373 7599 ext 84494
Email	c.nimhurchu@ctru.auckland.ac.nz

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	Effect of Chitosan on Health and Obesity
Study acronym	ECHO
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Obesity
Intervention	3 g Chitosan daily versus placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Chitosan
Primary outcome measure	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 study start date	01/11/2001
Completion date	30/06/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	250
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2001
Date of final enrolment	30/06/2003

Locations

Countries of recruitment

New Zealand

Study participating centre

Clinical Trials Research Unit

Auckland
-
New Zealand

Sponsor information

Health Research Council of New Zealand (New Zealand)
Research council

PO Box 5541
Wellesley Street
Auckland
1001
New Zealand

Phone	+64 (0)9 379 8227
Email	bscoggins@hrc.govt.nz
"ROR"	https://ror.org/00zbf3d93

Funders

Funder type

Research council

The Health Research Council of New Zealand (New Zealand)

No information available

Healtheries of New Zealand Ltd (New Zealand)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article		01/09/2004	Yes	No
Results article		17/12/2004	Yes	No
Other publications	Systematic review	01/02/2005	Yes	No

Editorial Notes

08/11/2022: Internal review.