The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

NCT05710055 | Completed

• 1 other identifier: 22-SM-12-WL-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Overweight

Keywords

Probiotics; Prebiotics; Overweight

Outcome Measures

Primary Outcomes (1)

• Change of Weight

  Change of Weight in Kg by Inbody S10 from baseline to 2 months

  baseline day 0, day 60

Secondary Outcomes (8)

• Blood lipids - Total Cholesterol Level

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

• Blood Sugar Level

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

• Blood Hormone - Leptin Level

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

• Blood Hormone - Adiponectin Level

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

• Blood inflammation

  baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

Study Arms (4)

Study product A (Wonderlab wonder4shape)

ACTIVE COMPARATOR

2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU: * CECT7527, CECT7528, CECT7529, B420, HN019 * FOS * Polydextrose * IMO

Dietary Supplement: Study product A (Wonderlab wonder4shape)

Study product B (Wonderlab wonder4shape)

ACTIVE COMPARATOR

2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU: * B420, HN019, NCFM * FOS * Polydextrose * IMO

Dietary Supplement: Study product B (Wonderlab wonder4shape)

Study product C (Wonderlab wonder4shape)

ACTIVE COMPARATOR

2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU: * CECT7527, CECT7528, CECT7529, B420, HN019 * XOS * Polydextrose * IMO

Dietary Supplement: Study product C (Wonderlab wonder4shape)

Study product D

PLACEBO COMPARATOR

2g/bottle: * MD * Cucumber powder

Dietary Supplement: Study product D

Interventions

Study product A (Wonderlab wonder4shape) DIETARY_SUPPLEMENT

Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months

Study product A (Wonderlab wonder4shape)

Study product B (Wonderlab wonder4shape) DIETARY_SUPPLEMENT

Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months

Study product B (Wonderlab wonder4shape)

Study product C (Wonderlab wonder4shape) DIETARY_SUPPLEMENT

Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months

Study product C (Wonderlab wonder4shape)

Study product D DIETARY_SUPPLEMENT

Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months

Study product D

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;
• 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.

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 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.

Sponsors & Collaborators

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

Study Sites (2)

Ai'er Hospital

Shanghai, Shanghai Municipality, China

Location

SPRIM Central Lab

Shanghai, Shanghai Municipality, China

Location

Related Publications (11)

• 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.

  PMID: 30924853 BACKGROUND

• 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.

  PMID: 32258541 BACKGROUND

• 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.

  PMID: 33669580 BACKGROUND

• 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.

  PMID: 33408364 BACKGROUND

• 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.

  PMID: 33487271 BACKGROUND

• 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.

  PMID: 34205871 BACKGROUND

• 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.

  PMID: 27810310 BACKGROUND

• 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.

  PMID: 25056655 BACKGROUND

• 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.

  PMID: 21663486 BACKGROUND

• 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.

  PMID: 23017585 BACKGROUND

• 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.

  PMID: 33917503 BACKGROUND

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• 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: January 5, 2023
• First Posted: February 2, 2023
• Study Start: February 6, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)