ObesityNCT02606669
The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects
A study testing Meal Replacement in people with Obesity and Fasting, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial summary
Background and Aims: The "5:2 diet", a form of intermittent energy restriction, has been popularized in Europe and USA. The rationale behind this approach is that two days of dieting is potentially more achievable, yet long enough to reduce overall weekly energy intake. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Meal Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2015to Jul 2017
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent.
- Chinese. (Both parents must be Chinese)
- Age above 21 years old. This study will focus only on adult subjects, and 21 years old is chosen as the age cut off, as it is the recognised legal age of independent consent.
- BMI ≥ 25 kg/m2
Who cannot join
- Pregnant, or any possibility of being pregnant (based on last menstrual period).
- Lactation.
- Age above 70 years old and/or suffering from cancer, diabetes, or any major cardiovascular disease, respiratory, psychiatric or musculoskeletal morbidity.
- Currently dieting or losing weight
- Unable to tolerate or complete two consecutive days of fasting during a two-day trial before recruitment.
- Unwilling to be randomised into intervention or control group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects: a Pilot Randomized Control Trial
Background and Aims: The "5:2 diet", a form of intermittent energy restriction, has been popularized in Europe and USA. The rationale behind this approach is that two days of dieting is potentially more achievable, yet long enough to reduce overall weekly energy intake. However, this specific approach is lacking in evidence. Therefore, we are keen to investigate the effectiveness of this form of intermittent energy restriction compared with a control intervention (providing dietary and exercise advice only), in overweight, Chinese subjects, for an intervention period of 12 weeks.
Design and Methods: This will be a randomized controlled trial, with 15 subjects in each arm, for an intervention period of 12 weeks. Subjects randomized to the treatment group will take three packets of a meal replacement product (Optifast®) per day during two consecutive fasting days, and take a healthy balanced diet that meet estimated energy requirements for the remaining five days. Subjects randomized to the control group will be given general diet advice and allowed to eat ad libitum throughout the study period. Measurements and laboratory tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary interventions will be assessed at 4 weeks and 12 weeks using 7-day food diaries.
Significance: This will be the first study looking at an Asian population and will serve as a pilot towards a larger randomized trial. If this approach is found to be safe, effective and easier to adhere compared to the traditional continuous energy restriction, then it will be a very valuable option in the treatment of obesity, which has become an increasing problem globally including Singapore.
Read the detailed description
- STUDY DESIGN This will be a single centre, randomized controlled trial (RCT), comparing the intervention in question (Intermittent Energy Restriction (IER), "5:2 diet", treatment: 2 consecutive days of fasting (using meal replacement, Optifast®) per week) with a control of "advice only", with 15 participants in each arm, in an adult overweight, Chinese sample, for an intervention period of 12 weeks. Each potential participant will be subjected to a pre-study assessment and a trial of 2 consecutive fasting days with Optifast® as per intervention. Potential participants will be formally enrolled into the study if they successfully tolerated the 2 consecutive fasting days with no contraindications to participation. The actual study period is 12 weeks, consisting of 4 study visits and 3 telephone calls between the study visits. This study design with a control arm (and randomisation) would provide more conclusive evidence if there is a significant difference between the two groups at the end of the study, with the difference most likely attributed to the intervention (IER, "5:2 diet", treatment).
- METHODS AND ASSESSMENTS
2.1. Randomisation and Blinding Eligible subjects will be randomised to two groups: the intervention group and the control group. This will be achieved using an online randomisation plan generator (www.randomization.com), with the plan generated by the Clinical Research Unit in Khoo Teck Puat Hospital (KTPH). Assignment will be contained within opaque sealed envelopes, and opened only in the presence of the investigator and the subject.
With regards to blinding, only personnel performing laboratory measurements will be blinded to the group allocation of the subjects. The rest of the study personnel, including the research nurse taking the anthropometric measurements, will not be blinded.
2.2. Contraception and Pregnancy Testing Females of childbearing age included in the trial will be discouraged from getting pregnant during the study period, but contraception will not be strictly enforced. However, if any participant is found to be pregnant or might be pregnant during the course of the study, she will be withdrawn from the study in view of the nutritional demands of pregnancy.
2.3. Study Visits and Procedures
- Pre-study trial and procedures Interested participants will be assessed for their suitability for the study including physical and psychological health, and their motivation to lose weight. Those who continue to be eligible will be given a trial of 2 consecutive fasting days with Optifast® as per intervention in this study. Those who successfully completed this trial and still express interest in this study will be formally recruited into the study, and the first study visit will then be arranged.
- Week 0: Study Visit 1 Measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) and laboratory tests (Fasting Lipids, Fasting Glucose, Fasting Insulin, Liver panel, Full Blood Count, B-hydroxybutyrate) will be done during this visit. Quality Of Life (QOL) will be assessed using the RAND Short Form (SF)-36 health survey during this visit.
- Week 4: Study Visit 2 Measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) and laboratory tests (Fasting Lipids, Fasting Glucose, Fasting Insulin, Liver panel, Full Blood Count, B-hydroxybutyrate) will be done during this visit. Adherence to the dietary interventions will be assessed based on 7-day food diaries done prior to study visit.
- Week 8: Study Visit 3 Only measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) will be done during this visit.
- Weeks 2, 6 and 10: Telephone Call Subjects will be contacted via telephone to reinforce compliance to study protocol and asked for any adverse effects during these calls.
- Week 12: Final Study Visit Measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) and laboratory tests (Fasting Lipids, Fasting Glucose, Fasting Insulin, Liver panel, Full Blood Count, B-hydroxybutyrate) will be done during this visit. Adherence to the dietary interventions will be assessed based on 7-day food diaries done prior to study visit. QOL will be assessed using the RAND Short Form-36 health survey.
- Discontinuation Visit and Procedures Participants may withdraw voluntarily from participation in the study at any time. If this occurs, the reason to withdraw will be documented and participants will be offered other obesity treatment options in Health For Life Centre (HFLC), KTPH. Subjects who accept other treatment options will be managed accordingly like usual patients treated in HFLC, KTPH and there will be no further trial procedures for these subjects. However, if subjects no longer wish to embark on a weight loss journey, they will be advised to continue scheduled evaluations as per protocol as far as possible to facilitate an intention to treat analysis.
- Being tested
- Meal Replacement
- Medical subject headings
- Obesity, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal ReplacementDietary supplement
Using a Meal Replacement product, supplemented by protein powder and multivitamin
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | The intervention of interest here is the Intermittent Energy Restriction (IER) or the Intermittent Fasting approach, specifically, the "5:2" diet, where adherence to this dietary intervention consists of fasting for two consecutive days and consuming enough to meet energy requirements for the remaining five non-fasting days. In this study, fasting will be achieved by using a meal replacement product (Optifast®) supplemented by two scoops of protein powder (Propass®) and a multivitamin, making a total of 540kcal (54g protein, 60g carbohydrates) for each fasting day. Receives: Dietary Supplement: Meal Replacement |
| Control | No intervention | Diet and Physical Activity advice only. No treatment plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Body Weight (in kg) at 3 months compared to baseline
Measured: Baseline to 3 months
Secondary outcomes (12)
Change in Quality of Life (as determined by RAND Short Form-36 health survey) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Insulin Sensitivity % (as determined by the Homeostasis Model Assessment (HOMA)) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Total Cholesterol levels (in mmol/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Low Density Lipoprotein (LDL)- Cholesterol levels (in mmol/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in High Density Lipoprotein (HDL)-Cholesterol levels (in mmol/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Triglyceride levels (in mmol/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Waist Circumference (in cm) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Body Fat % (as determined by bio-electrical impedance analysis) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Hip circumference (in cm) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Alanine transaminase (ALT) levels (in U/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Aspartate aminotransferase (AST) levels (in U/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Change in Gamma-glutamyl transpeptidase (GGT) levels (in U/L) at 3 months compared to baseline
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Lam, Khoo Teck Puat Hospital
- Investigators
- Benjamin Lam, MBBS, MMed, Principal investigator, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606669
- Sponsor's protocol ID
- 2015/00815
- Other IDs
- 2015
- Status last verified
- Aug 2017
- First submitted
- 13 Nov 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
PubMed 20921964Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
PubMed 23591120Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02606669
- Acronym / sponsor ID
- 2015/00815
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Nov 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.
Background and Aims: The "5:2 diet", a form of intermittent energy restriction, has been popularized in Europe and USA. The rationale behind this approach is that two days of dieting is potentially more achievable, yet long enough to reduce overall weekly energy intake. However, this specific approach is lacking in evidence. Therefore, we are keen to investigate the effectiveness of this form of intermittent energy restriction compared with a control intervention (providing dietary and exercise advice only), in overweight, Chinese subjects, for an intervention period of 12 weeks.
Design and Methods: This will be a randomized controlled trial, with 15 subjects in each arm, for an intervention period of 12 weeks. Subjects randomized to the treatment group will take three packets of a meal replacement product (Optifast®) per day during two consecutive fasting days, and take a healthy balanced diet that meet estimated energy requirements for the remaining five days. Subjects randomized to the control group will be given general diet advice and allowed to eat ad libitum throughout the study period. Measurements and laboratory tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary interventions will be assessed at 4 weeks and 12 weeks using 7-day food diaries.
Significance: This will be the first study looking at an Asian population and will serve as a pilot towards a larger randomized trial. If this approach is found to be safe, effective and easier to adhere compared to the traditional continuous energy restriction, then it will be a very valuable option in the treatment of obesity, which has become an increasing problem globally including Singapore.
Detailed description
- STUDY DESIGN This will be a single centre, randomized controlled trial (RCT), comparing the intervention in question (Intermittent Energy Restriction (IER), "5:2 diet", treatment: 2 consecutive days of fasting (using meal replacement, Optifast®) per week) with a control of "advice only", with 15 participants in each arm, in an adult overweight, Chinese sample, for an intervention period of 12 weeks. Each potential participant will be subjected to a pre-study assessment and a trial of 2 consecutive fasting days with Optifast® as per intervention. Potential participants will be formally enrolled into the study if they successfully tolerated the 2 consecutive fasting days with no contraindications to participation. The actual study period is 12 weeks, consisting of 4 study visits and 3 telephone calls between the study visits. This study design with a control arm (and randomisation) would provide more conclusive evidence if there is a significant difference between the two groups at the end of the study, with the difference most likely attributed to the intervention (IER, "5:2 diet", treatment).
- METHODS AND ASSESSMENTS
2.1. Randomisation and Blinding Eligible subjects will be randomised to two groups: the intervention group and the control group. This will be achieved using an online randomisation plan generator (www.randomization.com), with the plan generated by the Clinical Research Unit in Khoo Teck Puat Hospital (KTPH). Assignment will be contained within opaque sealed envelopes, and opened only in the presence of the investigator and the subject.
With regards to blinding, only personnel performing laboratory measurements will be blinded to the group allocation of the subjects. The rest of the study personnel, including the research nurse taking the anthropometric measurements, will not be blinded.
2.2. Contraception and Pregnancy Testing Females of childbearing age included in the trial will be discouraged from getting pregnant during the study period, but contraception will not be strictly enforced. However, if any participant is found to be pregnant or might be pregnant during the course of the study, she will be withdrawn from the study in view of the nutritional demands of pregnancy.
2.3. Study Visits and Procedures
- Pre-study trial and procedures Interested participants will be assessed for their suitability for the study including physical and psychological health, and their motivation to lose weight. Those who continue to be eligible will be given a trial of 2 consecutive fasting days with Optifast® as per intervention in this study. Those who successfully completed this trial and still express interest in this study will be formally recruited into the study, and the first study visit will then be arranged.
- Week 0: Study Visit 1 Measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) and laboratory tests (Fasting Lipids, Fasting Glucose, Fasting Insulin, Liver panel, Full Blood Count, B-hydroxybutyrate) will be done during this visit. Quality Of Life (QOL) will be assessed using the RAND Short Form (SF)-36 health survey during this visit.
- Week 4: Study Visit 2 Measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) and laboratory tests (Fasting Lipids, Fasting Glucose, Fasting Insulin, Liver panel, Full Blood Count, B-hydroxybutyrate) will be done during this visit. Adherence to the dietary interventions will be assessed based on 7-day food diaries done prior to study visit.
- Week 8: Study Visit 3 Only measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) will be done during this visit.
- Weeks 2, 6 and 10: Telephone Call Subjects will be contacted via telephone to reinforce compliance to study protocol and asked for any adverse effects during these calls.
- Week 12: Final Study Visit Measurements (height, weight, waist circumference, hip circumference, %body fat by bio-electrical impedance analysis, blood pressure) and laboratory tests (Fasting Lipids, Fasting Glucose, Fasting Insulin, Liver panel, Full Blood Count, B-hydroxybutyrate) will be done during this visit. Adherence to the dietary interventions will be assessed based on 7-day food diaries done prior to study visit. QOL will be assessed using the RAND Short Form-36 health survey.
- Discontinuation Visit and Procedures Participants may withdraw voluntarily from participation in the study at any time. If this occurs, the reason to withdraw will be documented and participants will be offered other obesity treatment options in Health For Life Centre (HFLC), KTPH. Subjects who accept other treatment options will be managed accordingly like usual patients treated in HFLC, KTPH and there will be no further trial procedures for these subjects. However, if subjects no longer wish to embark on a weight loss journey, they will be advised to continue scheduled evaluations as per protocol as far as possible to facilitate an intention to treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Dietary Supplement: Meal ReplacementThe intervention of interest here is the Intermittent Energy Restriction (IER) or the Intermittent Fasting approach, specifically, the "5:2" diet, where adherence to this dietary intervention consists of fasting for two consecutive days and consuming enough to meet energy requirements for the remaining five non-fasting days. In this study, fasting will be achieved by using a meal replacement product (Optifast®) supplemented by two scoops of protein powder (Propass®) and a multivitamin, making a total of 540kcal (54g protein, 60g carbohydrates) for each fasting day. |
| Control | No intervention | –Diet and Physical Activity advice only. No treatment plan. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide informed consent.
- Chinese. (Both parents must be Chinese)
- Age above 21 years old. This study will focus only on adult subjects, and 21 years old is chosen as the age cut off, as it is the recognised legal age of independent consent.
- BMI ≥ 25 kg/m2
Key exclusion criteria (6 listed)
- Pregnant, or any possibility of being pregnant (based on last menstrual period).
- Lactation.
- Age above 70 years old and/or suffering from cancer, diabetes, or any major cardiovascular disease, respiratory, psychiatric or musculoskeletal morbidity.
- Currently dieting or losing weight
- Unable to tolerate or complete two consecutive days of fasting during a two-day trial before recruitment.
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 ReplacementUsing a Meal Replacement product, supplemented by protein powder and multivitamin | Dietary supplement | Intermittent Fasting |
Primary outcome
Change in Total Body Weight (in kg) at 3 months compared to baseline
Time frame: Baseline to 3 months
12 secondary outcomes
Change in Quality of Life (as determined by RAND Short Form-36 health survey) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Insulin Sensitivity % (as determined by the Homeostasis Model Assessment (HOMA)) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Total Cholesterol levels (in mmol/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Low Density Lipoprotein (LDL)- Cholesterol levels (in mmol/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in High Density Lipoprotein (HDL)-Cholesterol levels (in mmol/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Triglyceride levels (in mmol/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Waist Circumference (in cm) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Body Fat % (as determined by bio-electrical impedance analysis) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Hip circumference (in cm) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Alanine transaminase (ALT) levels (in U/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Aspartate aminotransferase (AST) levels (in U/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Change in Gamma-glutamyl transpeptidase (GGT) levels (in U/L) at 3 months compared to baseline
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Background: PubMed 20921964Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
- Background: PubMed 23591120Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
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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.
Benjamin Lam, MBBS, MMed principal investigator
Khoo Teck Puat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Replacement in people with Obesity and Fasting, run by Khoo Teck Puat Hospital at 1 site in Singapore.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Aug 2017. 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 Singapore. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Body Weight (in kg) at 3 months compared to baseline (time frame: Baseline to 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 NCT02606669, which also lists 3 linked publications.
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 22 Aug 2017.