search
Back to results

The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Study product A (Wonderlab wonder4shape)
Study product B (Wonderlab wonder4shape)
Study product C (placebo)
Sponsored by
Shenzhen Precision Health Food Technology Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring Probiotics, Prebiotics, Wonderlab

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Chinese males or females, age between 25-45; Overweight population: BMI 24-27.9 & obesity population: BMI >=28; Blood lipids in high potential risks but without medication:TG > 5mol/L or LDL >= 3.4 mmol/L or TC >= 5.2 mmol/L. Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate; Agree to avoid medication treatment for weight management, including blood lipids and sugar control. Exclusion Criteria: Have used any medication for weight management at least one month before this study. Subject having done plastic surgery for weight management. Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product. Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently. Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease. Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study. Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment. Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis. Have any cuts/abrasions on the test site at baseline. The subject is an employee of sponsor or the site conducting the study.

Sites / Locations

  • SPRIM Central LabRecruiting
  • Ligang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Study product A (Wonderlab wonder4shape)

Study product B (Wonderlab wonder4shape)

Study product C (placebo)

Arm Description

2g/bottle, containing the following probiotics total dosage 2.0*1010 CFU: CECT7527, CECT7528, CECT7529 Maltodextrin Lactobacillus acidophilus Fructose oligosaccharides Grapefruit, Lemon and Apple powder

2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU: Maltodextrin Lactobacillus acidophilus

2g/bottle, containing the following ingredients: Maltodextrin Grapefruit powder Lemon powder

Outcomes

Primary Outcome Measures

Change of Weight
Change of Weight in Kg by Inbody S10 from baseline to 10 weeks

Secondary Outcome Measures

Blood lipids - Total Cholesterol Level
Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval
Blood Sugar Level
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L
Blood hormone - Leptin level
Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL
Blood hormone - Adiponectin level
Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL
Blood inflammation
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)

Full Information

First Posted
September 3, 2023
Last Updated
September 3, 2023
Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,
search

1. Study Identification

Unique Protocol Identification Number
NCT06030999
Brief Title
The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Official Title
Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
December 2, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this interventional study is to test whether consumption of Wonderlab probiotics with prebiotics could improve obesity and overweight in Chinese people who are aged 25-45 and overweight. The main question it aims to answer is: - whether the weight of participants can be lost after 10 weeks' intervention 150 participants will be randomized into 3 study groups (50 each group) in the two study sites, who will consume assigned product according to instructions for 10 weeks. Three site visits will be made for each participant and all relevant clinical data will be captured and recorded into CTMS(Clinical Trial Management System) for statistical analysis. Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Probiotics, Prebiotics, Wonderlab

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study product A (Wonderlab wonder4shape)
Arm Type
Active Comparator
Arm Description
2g/bottle, containing the following probiotics total dosage 2.0*1010 CFU: CECT7527, CECT7528, CECT7529 Maltodextrin Lactobacillus acidophilus Fructose oligosaccharides Grapefruit, Lemon and Apple powder
Arm Title
Study product B (Wonderlab wonder4shape)
Arm Type
Active Comparator
Arm Description
2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU: Maltodextrin Lactobacillus acidophilus
Arm Title
Study product C (placebo)
Arm Type
Placebo Comparator
Arm Description
2g/bottle, containing the following ingredients: Maltodextrin Grapefruit powder Lemon powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product A (Wonderlab wonder4shape)
Intervention Description
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product B (Wonderlab wonder4shape)
Intervention Description
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product C (placebo)
Intervention Description
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Primary Outcome Measure Information:
Title
Change of Weight
Description
Change of Weight in Kg by Inbody S10 from baseline to 10 weeks
Time Frame
baseline day 0, day 70
Secondary Outcome Measure Information:
Title
Blood lipids - Total Cholesterol Level
Description
Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval
Time Frame
baseline day 0, day 35, day 70
Title
Blood Sugar Level
Description
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L
Time Frame
baseline day 0, day 35, day 70
Title
Blood hormone - Leptin level
Description
Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL
Time Frame
baseline day 0, day 35, day 70
Title
Blood hormone - Adiponectin level
Description
Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL
Time Frame
baseline day 0, day 35, day 70
Title
Blood inflammation
Description
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)
Time Frame
baseline day 0, day 35, day 70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chinese males or females, age between 25-45; Overweight population: BMI 24-27.9 & obesity population: BMI >=28; Blood lipids in high potential risks but without medication:TG > 5mol/L or LDL >= 3.4 mmol/L or TC >= 5.2 mmol/L. Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate; Agree to avoid medication treatment for weight management, including blood lipids and sugar control. Exclusion Criteria: Have used any medication for weight management at least one month before this study. Subject having done plastic surgery for weight management. Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product. Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently. Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease. Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study. Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment. Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis. Have any cuts/abrasions on the test site at baseline. The subject is an employee of sponsor or the site conducting the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongwei Guo, MD
Organizational Affiliation
Shanghai Fudan University, School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weixing Wang, MD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
SPRIM Central Lab
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melody Hou
Phone
+8613917849430
Email
melody.hou@sprimmedical.com
Facility Name
Ligang Hospital
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie BC Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32676461
Citation
Aoun A, Darwish F, Hamod N. The Influence of the Gut Microbiome on Obesity in Adults and the Role of Probiotics, Prebiotics, and Synbiotics for Weight Loss. Prev Nutr Food Sci. 2020 Jun 30;25(2):113-123. doi: 10.3746/pnf.2020.25.2.113.
Results Reference
background
PubMed Identifier
31545802
Citation
Guirro M, Costa A, Gual-Grau A, Herrero P, Torrell H, Canela N, Arola L. Effects from diet-induced gut microbiota dysbiosis and obesity can be ameliorated by fecal microbiota transplantation: A multiomics approach. PLoS One. 2019 Sep 23;14(9):e0218143. doi: 10.1371/journal.pone.0218143. eCollection 2019.
Results Reference
background
PubMed Identifier
36161997
Citation
Gill VJS, Soni S, Shringarpure M, Anusheel, Bhardwaj S, Yadav NK, Patel A, Patel A. Gut Microbiota Interventions for the Management of Obesity: A Literature Review. Cureus. 2022 Sep 19;14(9):e29317. doi: 10.7759/cureus.29317. eCollection 2022 Sep.
Results Reference
background
PubMed Identifier
24912386
Citation
Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
Results Reference
background
PubMed Identifier
28611480
Citation
Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
Results Reference
background
PubMed Identifier
32826966
Citation
Swanson KS, Gibson GR, Hutkins R, Reimer RA, Reid G, Verbeke K, Scott KP, Holscher HD, Azad MB, Delzenne NM, Sanders ME. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nat Rev Gastroenterol Hepatol. 2020 Nov;17(11):687-701. doi: 10.1038/s41575-020-0344-2. Epub 2020 Aug 21.
Results Reference
background
PubMed Identifier
21294743
Citation
Arora T, Sharma R. Fermentation potential of the gut microbiome: implications for energy homeostasis and weight management. Nutr Rev. 2011 Feb;69(2):99-106. doi: 10.1111/j.1753-4887.2010.00365.x.
Results Reference
background
PubMed Identifier
16807088
Citation
Lee HY, Park JH, Seok SH, Baek MW, Kim DJ, Lee KE, Paek KS, Lee Y, Park JH. Human originated bacteria, Lactobacillus rhamnosus PL60, produce conjugated linoleic acid and show anti-obesity effects in diet-induced obese mice. Biochim Biophys Acta. 2006 Jul;1761(7):736-44. doi: 10.1016/j.bbalip.2006.05.007. Epub 2006 May 20.
Results Reference
background
PubMed Identifier
18197175
Citation
Martin FP, Wang Y, Sprenger N, Yap IK, Lundstedt T, Lek P, Rezzi S, Ramadan Z, van Bladeren P, Fay LB, Kochhar S, Lindon JC, Holmes E, Nicholson JK. Probiotic modulation of symbiotic gut microbial-host metabolic interactions in a humanized microbiome mouse model. Mol Syst Biol. 2008;4:157. doi: 10.1038/msb4100190. Epub 2008 Jan 15.
Results Reference
background
PubMed Identifier
30987812
Citation
Guazzelli Marques C, de Piano Ganen A, Zaccaro de Barros A, Thomatieli Dos Santos RV, Dos Santos Quaresma MVL. Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. Clin Nutr. 2020 Mar;39(3):694-704. doi: 10.1016/j.clnu.2019.03.034. Epub 2019 Apr 3.
Results Reference
background
PubMed Identifier
24186773
Citation
Bosch M, Fuentes MC, Audivert S, Bonachera MA, Peiro S, Cune J. Lactobacillus plantarum CECT 7527, 7528 and 7529: probiotic candidates to reduce cholesterol levels. J Sci Food Agric. 2014 Mar 15;94(4):803-9. doi: 10.1002/jsfa.6467. Epub 2013 Dec 4.
Results Reference
background
PubMed Identifier
14762068
Citation
Kim GB, Yi SH, Lee BH. Purification and characterization of three different types of bile salt hydrolases from Bifidobacterium strains. J Dairy Sci. 2004 Feb;87(2):258-66. doi: 10.3168/jds.S0022-0302(04)73164-1.
Results Reference
background
PubMed Identifier
16517616
Citation
Begley M, Hill C, Gahan CG. Bile salt hydrolase activity in probiotics. Appl Environ Microbiol. 2006 Mar;72(3):1729-38. doi: 10.1128/AEM.72.3.1729-1738.2006. No abstract available.
Results Reference
background
PubMed Identifier
31336737
Citation
Verhoog S, Taneri PE, Roa Diaz ZM, Marques-Vidal P, Troup JP, Bally L, Franco OH, Glisic M, Muka T. Dietary Factors and Modulation of Bacteria Strains of Akkermansia muciniphila and Faecalibacterium prausnitzii: A Systematic Review. Nutrients. 2019 Jul 11;11(7):1565. doi: 10.3390/nu11071565.
Results Reference
background
PubMed Identifier
31315227
Citation
Hills RD Jr, Pontefract BA, Mishcon HR, Black CA, Sutton SC, Theberge CR. Gut Microbiome: Profound Implications for Diet and Disease. Nutrients. 2019 Jul 16;11(7):1613. doi: 10.3390/nu11071613.
Results Reference
background

Learn more about this trial

The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

We'll reach out to this number within 24 hrs