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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030999
• Other study ID #: 23-SM-08-WL-001
• Status: Completed
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Shenzhen Precision Health Food Technology Co. Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 15, 2023
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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 > 5mmol/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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Study product A (Wonderlab wonder4shape)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
• Study product B (Wonderlab wonder4shape)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
• Study product C (placebo)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks

Locations

Country	Name	City	State
China	Ligang Hospital	Jinhua	Zhejiang
China	SPRIM Central Lab	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Precision Health Food Technology Co. Ltd.,

Country where clinical trial is conducted

China, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Weight	Change of Weight in Kg by Inbody S10 from baseline to 10 weeks	baseline day 0, day 70
Secondary	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
Secondary	Blood Sugar Level	Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L	baseline day 0, day 35, day 70
Secondary	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
Secondary	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
Secondary	Blood inflammation	Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)	baseline day 0, day 35, day 70