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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study product A (Wonderlab wonder4shape) | Active Comparator | 2g/bottle, containing the following probiotics total dosage 2.0*1010 CFU:
|
|
| Study product B (Wonderlab wonder4shape) | Active Comparator | 2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU:
|
|
| Study product C (placebo) | Placebo Comparator | 2g/bottle, containing the following ingredients:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study product A (Wonderlab wonder4shape) | Dietary Supplement | Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Weight | Change of Weight in Kg by Inbody S10 from baseline to 10 weeks | baseline day 0, day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline day 0, day 35, day 70 |
| Blood Sugar Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongwei Guo, MD | Shanghai Fudan University, School of Public Health | Principal Investigator |
| Weixing Wang, MD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPRIM Central Lab | Shanghai | Shanghai Municipality | China | |||
| Ligang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32676461 | Background | 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. | |
| 31545802 | Background | 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. |
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| Study product B (Wonderlab wonder4shape) | Dietary Supplement | Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks |
|
| Study product C (placebo) | Dietary Supplement | Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks |
|
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L
| baseline day 0, day 35, day 70 |
| Blood hormone - Leptin level | Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL | baseline day 0, day 35, day 70 |
| Blood hormone - Adiponectin level | Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL | baseline day 0, day 35, day 70 |
| Blood inflammation | Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) | baseline day 0, day 35, day 70 |
| Jinhua |
| Zhejiang |
| China |
| 36161997 | Background | 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. |
| 24912386 | Background | 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. |
| 28611480 | Background | 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. |
| 32826966 | Background | 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. |
| 21294743 | Background | 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. |
| 16807088 | Background | 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. |
| 18197175 | Background | 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. |
| 30987812 | Background | 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. |
| 24186773 | Background | 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. |
| 14762068 | Background | 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. |
| 16517616 | Background | 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. |
| 31336737 | Background | 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. |
| 31315227 | Background | 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. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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