Abdominal Obesity-Metabolic SyndromePhase 3SlimWellNCT02626741
Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome
A Phase 3 study testing meal replacement group in people with Abdominal Obesity-Metabolic Syndrome, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Obesity-Metabolic Syndrome
- What is being tested?
- meal replacement group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index more than or equal to 25 kg/m2
- Patients with metabolic syndrome
- Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.
Who cannot join
- Uncontrolled diabetes patients
- Patients with gastrointestinal abnormalities
- Patients with cardiovascular diseases
- Patients with hematologic disorders
- Patients with Glomerular filtration rate less than 60 ml/min/1.73m2
- Patients with drug or alcohol abuse
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Kusuma Chaiyasoot, MD, +66819304743, kusuma.chs@mahidol.ac.th
Kusuma Chaiyasoot, MD
About this study
Official title: Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial
The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.
Read the detailed description
The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification.
Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.
- Conditions
- Abdominal Obesity-Metabolic Syndrome
- Being tested
- meal replacement group, control group
- Medical subject headings
- Abdominal obesity metabolic syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal replacement groupDietary supplement
Also called SlimWell
The participants will receive SlimWell 60 grams per meal for 2 meals per day plus life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
control groupBehavioural
Also called only life style modification
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
| Study group | Role | What they receive |
|---|---|---|
| meal replacement group | Experimental | the participants receive a meal replacement plus life style modification Receives: Dietary Supplement: meal replacement group; Behavioral: control group |
| control group | Experimental | the participants receive life style modification only. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with weight loss unit in kilograms
Change from baseline body weight at 3 months
Measured: 3 months
Secondary outcomes (3)
Participants with waist circumference change in centimeters
Change from baseline waist circumference at 3 months
Measured: 3 months
Participants with triglyceride change in mg/dl.
Change from baseline triglyceride at 3 months
Measured: 3 months
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0 focus on Gastrointestinal side effects.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Obesity-Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kusuma Chaiyasoot, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626741
- Sponsor's protocol ID
- 647-2557-EC4
- Acronym
- SlimWell
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Leader NJ, Ryan L, Molyneaux L, Yue DK. How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. Obesity (Silver Spring). 2013 Feb;21(2):251-3. doi: 10.1002/oby.20057.
PubMed 23404963
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02626741
- Acronym / sponsor ID
- SlimWell / 647-2557-EC4
- Conditions
- Abdominal Obesity-Metabolic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.
Detailed description
The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification.
Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meal replacement group | Experimental | Dietary Supplement: meal replacement group, Behavioral: control groupthe participants receive a meal replacement plus life style modification |
| control group | Experimental | Behavioral: control groupthe participants receive life style modification only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index more than or equal to 25 kg/m2
- Patients with metabolic syndrome
- Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.
Key exclusion criteria (7 listed)
- Uncontrolled diabetes patients
- Patients with gastrointestinal abnormalities
- Patients with cardiovascular diseases
- Patients with hematologic disorders
- Patients with Glomerular filtration rate less than 60 ml/min/1.73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meal replacement groupAlso: SlimWellThe participants will receive SlimWell 60 grams per meal for 2 meals per day plus life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months. | Dietary supplement | meal replacement group |
| control groupAlso: only life style modificationThe participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months. | Behavioural | control group, meal replacement group |
Primary outcome
Participants with weight loss unit in kilograms
Time frame: 3 months
Change from baseline body weight at 3 months
3 secondary outcomes
Participants with waist circumference change in centimeters
Time frame: 3 months
Participants with triglyceride change in mg/dl.
Time frame: 3 months
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Background: PubMed 23404963Leader NJ, Ryan L, Molyneaux L, Yue DK. How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. Obesity (Silver Spring). 2013 Feb;21(2):251-3. doi: 10.1002/oby.20057.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kusuma Chaiyasoot, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing meal replacement group in people with Abdominal Obesity-Metabolic Syndrome, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kusuma Chaiyasoot, MD (+66819304743, kusuma.chs@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with weight loss unit in kilograms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.