Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05000775
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2021-08-02
Brief Title:
The Influence of GNiib in Obesity Management in Obese Young Individuals in Hong Kong
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 In 2010 our team recruited a cohort of obese adolescents mean age at baseline 172 years mean body mass index BMI 309 kgm2 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
1 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
2 Willingness to give written consent
Exclusion Criteria
1 Subjects who are allergic to any ingredients listed in G-NiiB microbiome immunity formula
2 Subjects with any condition that the investigator deems as a sound reason eg 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 levellog 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 probioticsnutritional supplements eg 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 11 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 Iintervention or Ccontrol 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 hisher 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 levellog 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 probioticsnutritional supplements eg 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
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
1 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
2 Willingness to give written consent
Exclusion Criteria
1 Subjects who are allergic to any ingredients listed in G-NiiB microbiome immunity formula
2 Subjects with any condition that the investigator deems as a sound reason eg 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 levellog 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 probioticsnutritional supplements eg 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 11 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 Iintervention or Ccontrol 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 hisher 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 levellog 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 probioticsnutritional supplements eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None