A study to evaluate the effect of orlistat + resveratrol combination on weight management
| ISRCTN | ISRCTN10642495 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10642495 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | EMB/MED/PRO/ORR/22/03/MY/01 |
| Sponsor | Zydus Lifesciences Ltd |
| Funder | Zydus Lifesciences Ltd. |
- Submission date
- 22/06/2022
- Registration date
- 04/07/2022
- Last edited
- 02/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Orlistat is intended to promote weight loss in addition to lifestyle modifications in overweight and obese individuals. Several patients taking orlistat do not achieve target weight loss despite adherence to therapy but lack adherence to exercise or diet modification. The addition of resveratrol to orlistat is intended to overcome these behavioral limitations leading to incremental metabolic benefits over orlistat alone.
Who can participate?
This study involves people aged 18 years or older with obesity/overweight (BMI more than or equal to 25 kg/m²).
What does the study involve?
The study involves treating people with obesity/overweight with either orlistat or orlistat + resveratrol for a period of 12 weeks.
What are the possible benefits and risks of participating?
The benefits of participating include active participation in weight reduction, while the risks include exposure to the side effects associated with orlistat (e.g. flatus with or without discharge).
Where is the study run from?
Defence Services General Hospital (Myanmar)
When is the study starting and how long is it expected to run for?
March 2022 to January 2023
Who is funding the study?
Zydus Lifesciences Ltd. (India)
Who is the main contact?
Dr Hardik Gandhi, hardikp.gandhi@zyduslife.com
Contact information
Scientific
Zydus Corporate Park
Gujarat
382481
India
 ORCID ID |
0000-0001-8274-828X |
|---|---|
| Phone | +91 7948040331 |
| hardikp.gandhi@zyduslife.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A prospective, post-marketing study to evaluate the efficacy and safety of orlistat + resveratrol combination (Zytrim-R) |
| Study acronym | EC-FIT |
| Study objectives | Orlistat + resveratrol has better efficacy in terms of weight reduction as compared to orlistat in obese/overweight subjects |
| Ethics approval(s) | Approved 08/06/2022, Defence Services General Hospital Ethics Committee (Defence Services General Hospital, Mingaladon, Yangon 11021, Myanmar; +95 (0)95011780; tnaing69@gmail.com), ref: HRC2022/DSGH1/001 |
| Health condition(s) or problem(s) studied | Obesity and overweight |
| Intervention | Randomization: online tool for random sequence generation Control arm: orlistat 120 mg hard capsules thrice daily Test arm: orlistat 120 mg + resveratrol 100 mg hard capsules thrice daily Duration of treatment: 12 weeks, Follow-up period: 12 weeks |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Orlistat, resveratrol |
| Primary outcome measure(s) |
% of patients achieving more than or equal to 5% weight loss as compared to baseline. Weight will be measured using a digital weighing scale at baseline and 12 weeks. |
| Key secondary outcome measure(s) |
1. Mean change in weight (Δ kg) measured using a digital weighing scale at baseline and 12 weeks |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 264 |
| Key inclusion criteria | 1. Subjects of either sex (male or female) having age ≥18 years 2. Subjects with a BMI ≥25 kg/m² (overweight or obese) with or without metabolic syndrome (or components of metabolic syndrome like hypertension, type 2 diabetes, dyslipidemia or fatty liver) and prescribed orlistat or orlistat+resveratrol by their treating physician 3. Subjects and/or their legal guardian able to provide written informed consent and willing to comply with physician’s instructions |
| Key exclusion criteria | 1. Subjects receiving orlistat other than Zytrim or Zytrim-R 2. Any contraindication for orlistat or orlistat + resveratrol as per the prescribing information 3. Subject simultaneously participating in any other clinical studies or having participated in any other clinical trial in the past 3 months (except survey-based studies) 4. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV infection, or coronary artery disease) |
| Date of first enrolment | 30/07/2022 |
| Date of final enrolment | 10/10/2022 |
Locations
Countries of recruitment
- Myanmar
Study participating centre
Yangon
11021
Myanmar
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hardik Gandhi (hardikp.gandhi@zyduslife.com). The individual participant level data in anonymized will become available after publication of results. It will be available for researchers submitting a sound study design. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2022: The recruitment start date was changed from 10/07/2022 to 30/07/2022.
30/06/2022: Trial's existence confirmed by the Defence Services General Hospital Ethics Committee.
