ObesityNCT05000775
The Influence of GNiib® in Obesity Management in Obese Young Individuals in Hong Kong.
A study testing G-Niib in people with Obesity, run by Chinese University of Hong Kong.
Trial summary
Obesity is a global epidemic, and is an important cardio-metabolic risk factor associated with many non-communicable diseases, such as coronary artery disease (CAD), diabetes and non-alcoholic fatty liver diseases (NAFLD) (1-6). Read more about this study
- Who is it for?
- Ages 25 to 30 years
- Conditions the study is for
- Obesity
- What is being tested?
- G-Niib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Jun 2023
- 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 25 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
- Willingness to give written consent
Who cannot join
- Subjects who are allergic to any ingredients listed in G-NiiB®, microbiome immunity formula.
- Subjects with any condition that the investigator deems as a sound reason (e.g. active gastrointestinal diseases and malignancies) for disqualification from enrollment into the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of a Microbiome Immunity Formula on Alteration of Anthropometric and Glycemic Indices and Modulation of Gut Microbiome in Obese Young Individuals in Hong Kong: A Randomized, Double-blinded, Placebocontrolled Study.
Obesity is a global epidemic, and is an important cardio-metabolic risk factor associated with many non-communicable diseases, such as coronary artery disease (CAD), diabetes and non-alcoholic fatty liver diseases (NAFLD) (1-6). In 2010, our team recruited a cohort of obese adolescents [mean age at baseline: 17.2 years, mean body mass index (BMI): 30.9 kg/m2] from school surveys (7). Our group has examined the impact of dietary intervention using low glycemic index (GI) diet to reduce body weight of adolescents. We have reported that participants in the low GI group had a significantly greater reduction in obesity indices namely waist circumference after 6 months of intervention compared to counterparts in usual diet counselling group. We recently conducted a phone interview of the participants and most, if not all, of them remained obese from self-reported body weight. Pharmacological treatment options for obese individuals are limited (8-10). Amassing evidence showed that the gut microbiota plays an important role in energy harvesting and lipid metabolism. Gut microbiota dysbiosis was repeatedly reported in patients with obesity (11-13). Studies in humanized mouse models suggest that the obese gut microbiota was more efficient in harvesting energy from diet and may be a causative factor in the pathogenesis of metabolic disorders, including obesity, type 2 diabetes and NAFLD (14). Therefore, modulation of microbiota might be a potential strategy for prevention and treatment of metabolic disorders. Microbial-based therapeutics such as probiotics, prebiotics, symbiotic or fecal microbiota transplantation have shown promising effect in improving host metabolic health (15, 16). Prebiotics consumption changes the composition of gut microbiota, alters levels of satietogenic gut peptides, decreases systemic inflammation, and improves insulin sensitivity and glucose tolerance (17). Supplementation of probiotics in overweight and obese individuals with probiotics reduces body weight and obesity indices (16, 18, 19). The use of probiotics also reduces intrahepatic triglyceride (IHTG) in patients with non-alcoholic steatohepatitis (20) and improves post-prandial glucose control in subjects with type 2 diabetes (21). G-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts.
Read the detailed description
Study Design:
This will be a 24-week randomized double-blinded placebo-controlled study on the effect of G-NiiB®, CU Medicine Immunity Microbiome Formula, on young obese individuals who exited from a randomized controlled interventional trial with dietary intervention with low GI diet for 12-month that was conducted in 2010 (NCT no. 01278563). This study protocol complies with the Declaration of Helsinki and ICH-GCP guideline.
Subjects and Methods:
Inclusion Criteria:
- 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
- Willingness to give written consent
Exclusion Criteria:
- Subjects who are allergic to any ingredients listed in G-NiiB®, microbiome immunity formula.
- Subjects with any condition that the investigator deems as a sound reason (e.g. active gastrointestinal diseases and malignancies) for disqualification from enrollment into the study.
Study Procedures:
At screening visit:
Anthropometric measurements, including body weight and height, waist and hip circumferences, percentage body fat by bioimpedance (23).
Questionnaires to document 1) demographic data including past medical and history, birth weight, 2) 3-day diet record using locally validated questionnaires (24) and 3) physical activity level/log sheet (IPAQ) ; 4) change of eating behavior and quality of life by eating disorders examinations (EDE) and 36-item short form survey (SF-36).
Pharmacist to record past and present medication history, including prescribed drugs, over-the-counter drugs and supplements, especially, 1) Subjects who have received antibiotics, antifungal, antiparasitic, or antiviral treatment within 12 weeks prior to study entry; 2) Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study; 3) Subjects using proton pump inhibitor; 4) Present use of probiotics/nutritional supplements e.g., the use of replacement doses of Vitamin D, calcium supplements, and multi-vitamin tablet.
After an overnight fast of 8-10 hours, baseline blood tests will be sampled including plasma glucose, insulin, complete blood picture, renal and liver function tests, thyroid function test, lipid profiles, high sensitivity C-reactive protein (hs-CRP) (25). Additional 15ml of blood will be collected for PBMC isolation (22). Spot urine for albumin-creatinine ratio will be collected for detection of microalbuminuria (26). Various indexes of insulin resistance (HOMA-IR) and pancreatic beta-cell function (HOMA-beta) will be calculated from the homeostasis model assessment (27). Insulin secretion will be calculated from plasma glucose and insulin during various time points of OGTT.
Liver assessment by transient elastography (Fibroscan®), in which controlled attenuation parameter (CAP) will be used to detect liver steatosis while liver stiffness measurement (LSM) will be used to assess liver fibrosis (28).
Ultrasound scan for mesenteric fat, fatty liver and carotid intimal medial thickness will be performed (29, 30).
Stool for gut microbiota will be sampled. Blood for genetic studies (5ml), plasma (350 µL) and urine (500 µL) for metabolomics investigations will also be stored.
At randomization visit:
Participants will be randomly assigned to either intervention or control arms in 1:1 ratio. Allocation will be performed using block randomization with varying block sizes to maintain a good balance of subjects between the two arms and optimize allocation concealment throughout the subject recruitment period. A random sequence of grouping identifiers (I=intervention or C=control), based on computer-generated random codes will be prepared in advance by a statistician who is independent to arm allocation. The allocation sequence list will be password-protected and stored in a computer, and only be accessible to staff who is for arm allocation. The arm allocation of each participant will be assigned sequentially according to his/her sequence of enrolment and the corresponding group identifier in the prior prepared random sequence list. The research staff responsible for data collection will be blinded to the arm allocation.
All participants will be dispensed a 12-week supply of double-blinded study intervention or placebo products. Each participant will be given an administration log to record the daily intake of G-NiiB® or its placebo-control. Patient will be counselled to take one packet of the dispensed product once daily and record the time of ingestion and any adverse reactions in the logbook daily for a total of 24 weeks. Patient will be advised to take photo of the administration logbook within first week of enrollment into this study to ensure the log entry has been filled accurately. Patient will receive monthly phone calls from a pharmacist to ensure compliance of study product administration (31).
At interim study visit (at 12-week) All participants will be dispensed a 12-week supply of double-blinded study intervention or placebo products. Administration logbook will be checked by research staff. Adherence will be documented to compare the good adherence group and bad adherence group for the efficacy of the product provided. Good adherence is defined as missing not more than one daily dose of the product provided, while poor adherence is defined as missing two or daily dose of the product provided.
Anthropometric measurements, including body weight and height, waist and hip circumferences, percentage body fat by bioimpedance (23).
Questionnaires to document 1) demographic data including past medical and history, birth weight, 2) 3-day diet record using locally validated questionnaires (24) and 3) physical activity level/log sheet (IPAQ) ; 4) change of eating behavior and quality of life by eating disorders examinations (EDE) and 36-item short form survey (SF-36).
Pharmacist to record past and present medication history, including prescribed drugs, over-the-counter drugs and supplements, especially, 1) Subjects who have received antibiotics, antifungal, antiparasitic, or antiviral treatment within 12 weeks prior to study entry; 2) Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study; 3) Subjects using proton pump inhibitor; 4) Present use of probiotics/nutritional supplements e.g., the use of replacement doses of Vitamin D, calcium supplements, and multi-vitamin tablet.
After an overnight fast of 8-10 hours, baseline blood tests will be sampled including plasma glucose, insulin, complete blood picture, renal and liver function tests, thyroid function test, lipid profiles, high sensitivity C-reactive protein (hs-CRP) (25). Additional 15ml of blood will be collected for PBMC isolation (22). Spot urine for albumin-creatinine ratio will be collected for detection of microalbuminuria (26). Various indexes of insulin resistance (HOMA-IR) and pancreatic beta-cell function (HOMA-beta) will be calculated from the homeostasis model assessment (27). Insulin secretion will be calculated from plasma glucose and insulin during various time points of OGTT.
Liver assessment by transient elastography (Fibroscan®), in which controlled attenuation parameter (CAP) will be used to detect liver steatosis while liver stiffness measurement (LSM) will be used to assess liver fibrosis (28).
Stool for gut microbiota will be sampled. Blood for genetic studies (5ml), plasma (350 µL) and urine (500 µL) for metabolomics investigations will also be stored.
At follow-up visit (at 24-week) Repeat study procedures at baseline visit. All the unused products must be returned to research team for examination.
- Conditions
- Obesity
- Being tested
- G-Niib, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-NiibDietary supplement
G-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| G-Niib | Experimental | G-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts. Receives: Dietary Supplement: G-Niib |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects achieving 5% weight loss
Proportion of subjects achieving 5% weight loss is a standard measurement for weight management using probiotics/prebiotics.
Measured: 24 weeks
changes in BMI
Measured: 24 weeks
changes in body weight
Measured: 24 weeks
changes in waist circumference
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Pik Shan KONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000775
- Sponsor's protocol ID
- 20210615-001
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Microbiome Immunity Formula on Alteration of Anthropometric and Glycemic Indices and Modulation of Gut Microbiome in Obese Young Individuals in Hong Kong: A Randomized, Double-blinded, Placebocontrolled Study.
- ClinicalTrials.gov ID
- NCT05000775
- Acronym / sponsor ID
- 20210615-001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Aug 2021 (actual)
- 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.
Obesity is a global epidemic, and is an important cardio-metabolic risk factor associated with many non-communicable diseases, such as coronary artery disease (CAD), diabetes and non-alcoholic fatty liver diseases (NAFLD) (1-6). In 2010, our team recruited a cohort of obese adolescents [mean age at baseline: 17.2 years, mean body mass index (BMI): 30.9 kg/m2] from school surveys (7). Our group has examined the impact of dietary intervention using low glycemic index (GI) diet to reduce body weight of adolescents. We have reported that participants in the low GI group had a significantly greater reduction in obesity indices namely waist circumference after 6 months of intervention compared to counterparts in usual diet counselling group. We recently conducted a phone interview of the participants and most, if not all, of them remained obese from self-reported body weight. Pharmacological treatment options for obese individuals are limited (8-10). Amassing evidence showed that the gut microbiota plays an important role in energy harvesting and lipid metabolism. Gut microbiota dysbiosis was repeatedly reported in patients with obesity (11-13). Studies in humanized mouse models suggest that the obese gut microbiota was more efficient in harvesting energy from diet and may be a causative factor in the pathogenesis of metabolic disorders, including obesity, type 2 diabetes and NAFLD (14). Therefore, modulation of microbiota might be a potential strategy for prevention and treatment of metabolic disorders. Microbial-based therapeutics such as probiotics, prebiotics, symbiotic or fecal microbiota transplantation have shown promising effect in improving host metabolic health (15, 16). Prebiotics consumption changes the composition of gut microbiota, alters levels of satietogenic gut peptides, decreases systemic inflammation, and improves insulin sensitivity and glucose tolerance (17). Supplementation of probiotics in overweight and obese individuals with probiotics reduces body weight and obesity indices (16, 18, 19). The use of probiotics also reduces intrahepatic triglyceride (IHTG) in patients with non-alcoholic steatohepatitis (20) and improves post-prandial glucose control in subjects with type 2 diabetes (21). G-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts.
Detailed description
Study Design:
This will be a 24-week randomized double-blinded placebo-controlled study on the effect of G-NiiB®, CU Medicine Immunity Microbiome Formula, on young obese individuals who exited from a randomized controlled interventional trial with dietary intervention with low GI diet for 12-month that was conducted in 2010 (NCT no. 01278563). This study protocol complies with the Declaration of Helsinki and ICH-GCP guideline.
Subjects and Methods:
Inclusion Criteria:
- 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
- Willingness to give written consent
Exclusion Criteria:
- Subjects who are allergic to any ingredients listed in G-NiiB®, microbiome immunity formula.
- Subjects with any condition that the investigator deems as a sound reason (e.g. active gastrointestinal diseases and malignancies) for disqualification from enrollment into the study.
Study Procedures:
At screening visit:
Anthropometric measurements, including body weight and height, waist and hip circumferences, percentage body fat by bioimpedance (23).
Questionnaires to document 1) demographic data including past medical and history, birth weight, 2) 3-day diet record using locally validated questionnaires (24) and 3) physical activity level/log sheet (IPAQ) ; 4) change of eating behavior and quality of life by eating disorders examinations (EDE) and 36-item short form survey (SF-36).
Pharmacist to record past and present medication history, including prescribed drugs, over-the-counter drugs and supplements, especially, 1) Subjects who have received antibiotics, antifungal, antiparasitic, or antiviral treatment within 12 weeks prior to study entry; 2) Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study; 3) Subjects using proton pump inhibitor; 4) Present use of probiotics/nutritional supplements e.g., the use of replacement doses of Vitamin D, calcium supplements, and multi-vitamin tablet.
After an overnight fast of 8-10 hours, baseline blood tests will be sampled including plasma glucose, insulin, complete blood picture, renal and liver function tests, thyroid function test, lipid profiles, high sensitivity C-reactive protein (hs-CRP) (25). Additional 15ml of blood will be collected for PBMC isolation (22). Spot urine for albumin-creatinine ratio will be collected for detection of microalbuminuria (26). Various indexes of insulin resistance (HOMA-IR) and pancreatic beta-cell function (HOMA-beta) will be calculated from the homeostasis model assessment (27). Insulin secretion will be calculated from plasma glucose and insulin during various time points of OGTT.
Liver assessment by transient elastography (Fibroscan®), in which controlled attenuation parameter (CAP) will be used to detect liver steatosis while liver stiffness measurement (LSM) will be used to assess liver fibrosis (28).
Ultrasound scan for mesenteric fat, fatty liver and carotid intimal medial thickness will be performed (29, 30).
Stool for gut microbiota will be sampled. Blood for genetic studies (5ml), plasma (350 µL) and urine (500 µL) for metabolomics investigations will also be stored.
At randomization visit:
Participants will be randomly assigned to either intervention or control arms in 1:1 ratio. Allocation will be performed using block randomization with varying block sizes to maintain a good balance of subjects between the two arms and optimize allocation concealment throughout the subject recruitment period. A random sequence of grouping identifiers (I=intervention or C=control), based on computer-generated random codes will be prepared in advance by a statistician who is independent to arm allocation. The allocation sequence list will be password-protected and stored in a computer, and only be accessible to staff who is for arm allocation. The arm allocation of each participant will be assigned sequentially according to his/her sequence of enrolment and the corresponding group identifier in the prior prepared random sequence list. The research staff responsible for data collection will be blinded to the arm allocation.
All participants will be dispensed a 12-week supply of double-blinded study intervention or placebo products. Each participant will be given an administration log to record the daily intake of G-NiiB® or its placebo-control. Patient will be counselled to take one packet of the dispensed product once daily and record the time of ingestion and any adverse reactions in the logbook daily for a total of 24 weeks. Patient will be advised to take photo of the administration logbook within first week of enrollment into this study to ensure the log entry has been filled accurately. Patient will receive monthly phone calls from a pharmacist to ensure compliance of study product administration (31).
At interim study visit (at 12-week) All participants will be dispensed a 12-week supply of double-blinded study intervention or placebo products. Administration logbook will be checked by research staff. Adherence will be documented to compare the good adherence group and bad adherence group for the efficacy of the product provided. Good adherence is defined as missing not more than one daily dose of the product provided, while poor adherence is defined as missing two or daily dose of the product provided.
Anthropometric measurements, including body weight and height, waist and hip circumferences, percentage body fat by bioimpedance (23).
Questionnaires to document 1) demographic data including past medical and history, birth weight, 2) 3-day diet record using locally validated questionnaires (24) and 3) physical activity level/log sheet (IPAQ) ; 4) change of eating behavior and quality of life by eating disorders examinations (EDE) and 36-item short form survey (SF-36).
Pharmacist to record past and present medication history, including prescribed drugs, over-the-counter drugs and supplements, especially, 1) Subjects who have received antibiotics, antifungal, antiparasitic, or antiviral treatment within 12 weeks prior to study entry; 2) Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study; 3) Subjects using proton pump inhibitor; 4) Present use of probiotics/nutritional supplements e.g., the use of replacement doses of Vitamin D, calcium supplements, and multi-vitamin tablet.
After an overnight fast of 8-10 hours, baseline blood tests will be sampled including plasma glucose, insulin, complete blood picture, renal and liver function tests, thyroid function test, lipid profiles, high sensitivity C-reactive protein (hs-CRP) (25). Additional 15ml of blood will be collected for PBMC isolation (22). Spot urine for albumin-creatinine ratio will be collected for detection of microalbuminuria (26). Various indexes of insulin resistance (HOMA-IR) and pancreatic beta-cell function (HOMA-beta) will be calculated from the homeostasis model assessment (27). Insulin secretion will be calculated from plasma glucose and insulin during various time points of OGTT.
Liver assessment by transient elastography (Fibroscan®), in which controlled attenuation parameter (CAP) will be used to detect liver steatosis while liver stiffness measurement (LSM) will be used to assess liver fibrosis (28).
Stool for gut microbiota will be sampled. Blood for genetic studies (5ml), plasma (350 µL) and urine (500 µL) for metabolomics investigations will also be stored.
At follow-up visit (at 24-week) Repeat study procedures at baseline visit. All the unused products must be returned to research team for examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-Niib | Experimental | Dietary Supplement: G-NiibG-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
- Willingness to give written consent
Key exclusion criteria (2 listed)
- Subjects who are allergic to any ingredients listed in G-NiiB®, microbiome immunity formula.
- Subjects with any condition that the investigator deems as a sound reason (e.g. active gastrointestinal diseases and malignancies) for disqualification from enrollment into the study.
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 |
|---|---|---|
| G-NiibG-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts. | Dietary supplement | G-Niib |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
proportion of subjects achieving 5% weight loss
Time frame: 24 weeks
Proportion of subjects achieving 5% weight loss is a standard measurement for weight management using probiotics/prebiotics.
changes in BMI
Time frame: 24 weeks
changes in body weight
Time frame: 24 weeks
changes in waist circumference
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing G-Niib in people with Obesity, run by Chinese University of Hong Kong.
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 2 inclusion and 2 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 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Cheung (61898616, jamie.cheung@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of subjects achieving 5% weight loss (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2021.