The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Overweight Clinical Trial

Official title:

A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05710055
• Other study ID #: 22-SM-12-WL-001
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• 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 evaluate the efficacy of probiotics with prebiotics on overweight.

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.

Description:

This study is a multi-center, four arms, randomized, double-blind controlled trial. 200 Eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. All participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS (Clinical Trial Management System). Data will be analyzed and reported after the completion of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 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;

• 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:

• 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 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.

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
China	Ai'er Hospital	Shanghai	Shanghai
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 (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 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 2 months	baseline day 0, day 60
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, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Blood Sugar Level	Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Blood Hormone - Leptin Level	Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Blood Hormone - Adiponectin Level	Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Blood inflammation	Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Feces SCFA	Feces SCFA for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Feces sIgA	Feces sIgA for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Secondary	Liver function test	Liver function test for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90