Effect of Chitosan on Health and Obesity
| ISRCTN | ISRCTN96702062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96702062 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HRC 01/416 |
| Sponsor | Health Research Council of New Zealand (New Zealand) |
| Funders | The Health Research Council of New Zealand (New Zealand), Healtheries of New Zealand Ltd (New Zealand) |
- 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
Scientific
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
-
New Zealand
| Phone | +64 (0)9 373 7599 ext 84494 |
|---|---|
| c.nimhurchu@ctru.auckland.ac.nz |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chitosan |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
-
New Zealand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | 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.
