Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study product A (Wonderlab wonder4shape) | Active Comparator | 2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU:
|
|
| Study product B (Wonderlab wonder4shape) | Active Comparator | 2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU:
|
|
| Study product C (Wonderlab wonder4shape) | Active Comparator | 2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU:
|
|
| Study product D | Placebo Comparator | 2g/bottle:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Weight | Change of Weight in Kg by Inbody S10 from baseline to 2 months | baseline day 0, day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Blood Sugar Level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weixing Wang, MD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ai'er Hospital | Shanghai | Shanghai Municipality | China | |||
| SPRIM Central Lab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30924853 | Background | 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. | |
| 32258541 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 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 D | Dietary Supplement | Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months |
|
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 |
| 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 |
| 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 |
| 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 |
| Feces SCFA | Feces SCFA for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 |
| Feces sIgA | Feces sIgA for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 |
| 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 |
| Shanghai |
| Shanghai Municipality |
| China |
| 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. |
| 33669580 | 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. |
| 33408364 | 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. |
| 33487271 | 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. |
| 34205871 | 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. |
| 27810310 | 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. |
| 25056655 | 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. |
| 21663486 | 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. |
| 23017585 | 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. |
| 33917503 | 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. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided