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

NCT06030999 | Completed

• 1 other identifier: 23-SM-08-WL-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Keywords

Probiotics; Prebiotics; Wonderlab

Outcome Measures

Primary Outcomes (1)

• Change of Weight

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

  baseline day 0, day 70

Secondary Outcomes (5)

• Blood lipids - Total Cholesterol Level

  baseline day 0, day 35, day 70

• Blood Sugar Level

  baseline day 0, day 35, day 70

• Blood hormone - Leptin level

  baseline day 0, day 35, day 70

• Blood hormone - Adiponectin level

  baseline day 0, day 35, day 70

• Blood inflammation

  baseline day 0, day 35, day 70

Study Arms (3)

Study product A (Wonderlab wonder4shape)

ACTIVE COMPARATOR

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

Dietary Supplement: Study product A (Wonderlab wonder4shape)

Study product B (Wonderlab wonder4shape)

ACTIVE COMPARATOR

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

Dietary Supplement: Study product B (Wonderlab wonder4shape)

Study product C (placebo)

PLACEBO COMPARATOR

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

Dietary Supplement: Study product C (placebo)

Interventions

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

Study product A (Wonderlab wonder4shape)

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 B (Wonderlab wonder4shape)

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

Study product C (placebo)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Precision Health Food Technology Co. Ltd.,: lead

Study Sites (2)

SPRIM Central Lab

Shanghai, Shanghai Municipality, China

Location

Ligang Hospital

Jinhua, Zhejiang, China

Location

Related 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.

  PMID: 32676461 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.

  PMID: 31545802 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.

  PMID: 36161997 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.

  PMID: 24912386 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.

  PMID: 28611480 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.

  PMID: 32826966 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.

  PMID: 21294743 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.

  PMID: 16807088 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.

  PMID: 18197175 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.

  PMID: 30987812 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.

  PMID: 24186773 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.

  PMID: 14762068 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.

  PMID: 16517616 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.

  PMID: 31336737 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.

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MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongwei Guo, MD

  Shanghai Fudan University, School of Public Health

  PRINCIPAL INVESTIGATOR

• Weixing Wang, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: September 18, 2023
• Primary Completion: December 2, 2023
• Study Completion: December 15, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)