The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
NCT ID: NCT05710055
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2023-02-06
2023-04-30
Brief Summary
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200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months.
Reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Study product A (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU:
* CECT7527, CECT7528, CECT7529, B420, HN019
* FOS
* Polydextrose
* IMO
Study product A (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Study product B (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU:
* B420, HN019, NCFM
* FOS
* Polydextrose
* IMO
Study product B (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Study product C (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU:
* CECT7527, CECT7528, CECT7529, B420, HN019
* XOS
* Polydextrose
* IMO
Study product C (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Study product D
2g/bottle:
* MD
* Cucumber powder
Study product D
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Interventions
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Study product A (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Study product B (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Study product C (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Study product D
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Eligibility Criteria
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Inclusion Criteria
* Overweight population: BMI 24-27.9;
* Blood lipids in high potential risks but without medication; TG \> 5mol/L, LDL \>= 3.4 mmol/L, 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
* 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 enrollment.
* 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.
25 Years
45 Years
ALL
Yes
Sponsors
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Shenzhen Precision Health Food Technology Co. Ltd.,
OTHER_GOV
Responsible Party
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Principal Investigators
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Weixing Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Ai'er Hospital
Shanghai, Shanghai Municipality, China
SPRIM Central Lab
Shanghai, Shanghai Municipality, China
Countries
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References
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Suzumura EA, Bersch-Ferreira AC, Torreglosa CR, da Silva JT, Coqueiro AY, Kuntz MGF, Chrispim PP, Weber B, Cavalcanti AB. Effects of oral supplementation with probiotics or synbiotics in overweight and obese adults: a systematic review and meta-analyses of randomized trials. Nutr Rev. 2019 Jun 1;77(6):430-450. doi: 10.1093/nutrit/nuz001.
Rouxinol-Dias AL, Pinto AR, Janeiro C, Rodrigues D, Moreira M, Dias J, Pereira P. Probiotics for the control of obesity - Its effect on weight change. Porto Biomed J. 2016 Mar-Apr;1(1):12-24. doi: 10.1016/j.pbj.2016.03.005. Epub 2016 Mar 1.
Perna S, Ilyas Z, Giacosa A, Gasparri C, Peroni G, Faliva MA, Rigon C, Naso M, Riva A, Petrangolini G, A Redha A, Rondanelli M. Is Probiotic Supplementation Useful for the Management of Body Weight and Other Anthropometric Measures in Adults Affected by Overweight and Obesity with Metabolic Related Diseases? A Systematic Review and Meta-Analysis. Nutrients. 2021 Feb 19;13(2):666. doi: 10.3390/nu13020666.
Michael DR, Davies TS, Jack AA, Masetti G, Marchesi JR, Wang D, Mullish BH, Plummer SF. Daily supplementation with the Lab4P probiotic consortium induces significant weight loss in overweight adults. Sci Rep. 2021 Jan 6;11(1):5. doi: 10.1038/s41598-020-78285-3.
Nasiri G, Bastani A, Haji-Aghamohammadi AA, Nooshabadi MR, Shahmirzalou P, Haghighian HK. Effects of probiotic and alpha-lipoic acid supplements, separately or in combination on the anthropometric indicators and maintenance of weight in overweight individuals. Clin Nutr ESPEN. 2021 Feb;41:242-248. doi: 10.1016/j.clnesp.2020.12.007. Epub 2020 Dec 30.
Dechelotte P, Breton J, Trotin-Picolo C, Grube B, Erlenbeck C, Bothe G, Fetissov SO, Lambert G. The Probiotic Strain H. alvei HA4597(R) Improves Weight Loss in Overweight Subjects under Moderate Hypocaloric Diet: A Proof-of-Concept, Multicenter Randomized, Double-Blind Placebo-Controlled Study. Nutrients. 2021 Jun 1;13(6):1902. doi: 10.3390/nu13061902.
Stenman LK, Lehtinen MJ, Meland N, Christensen JE, Yeung N, Saarinen MT, Courtney M, Burcelin R, Lahdeaho ML, Linros J, Apter D, Scheinin M, Kloster Smerud H, Rissanen A, Lahtinen S. Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults-Randomized Controlled Trial. EBioMedicine. 2016 Nov;13:190-200. doi: 10.1016/j.ebiom.2016.10.036. Epub 2016 Oct 26.
Magro DO, de Oliveira LM, Bernasconi I, Ruela Mde S, Credidio L, Barcelos IK, Leal RF, Ayrizono Mde L, Fagundes JJ, Teixeira Lde B, Ouwehand AC, Coy CS. Effect of yogurt containing polydextrose, Lactobacillus acidophilus NCFM and Bifidobacterium lactis HN019: a randomized, double-blind, controlled study in chronic constipation. Nutr J. 2014 Jul 24;13:75. doi: 10.1186/1475-2891-13-75.
Waller PA, Gopal PK, Leyer GJ, Ouwehand AC, Reifer C, Stewart ME, Miller LE. Dose-response effect of Bifidobacterium lactis HN019 on whole gut transit time and functional gastrointestinal symptoms in adults. Scand J Gastroenterol. 2011 Sep;46(9):1057-64. doi: 10.3109/00365521.2011.584895. Epub 2011 Jun 13.
Fuentes MC, Lajo T, Carrion JM, Cune J. Cholesterol-lowering efficacy of Lactobacillus plantarum CECT 7527, 7528 and 7529 in hypercholesterolaemic adults. Br J Nutr. 2013 May 28;109(10):1866-72. doi: 10.1017/S000711451200373X. Epub 2012 Sep 28.
Guerrero-Bonmatty R, Gil-Fernandez G, Rodriguez-Velasco FJ, Espadaler-Mazo J. A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528, and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2021 Apr 6;13(4):1206. doi: 10.3390/nu13041206.
Other Identifiers
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22-SM-12-WL-001
Identifier Type: -
Identifier Source: org_study_id