OverweightNCT05710055
The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
A study testing Study product A (Wonderlab wonder4shape), Study product B (Wonderlab wonder4shape) and Study product C (Wonderlab wonder4shape) in people with Overweight, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Study product A (Wonderlab wonder4shape), Study product B (Wonderlab wonder4shape) and Study product C (Wonderlab wonder4shape)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 6 Feb 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Ai'er Hospital
Shanghai, Shanghai Municipality
SPRIM Central Lab
Shanghai, Shanghai Municipality
About this study
Official title: A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
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.
Read the detailed 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.
- Conditions
- Overweight
- Being tested
- Study product A (Wonderlab wonder4shape), Study product B (Wonderlab wonder4shape), Study product C (Wonderlab wonder4shape), Study product D
- Keywords
- Probiotics, Prebiotics, Overweight
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 DDietary supplement
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Study product C (Wonderlab wonder4shape) |
| Study product D | Placebo comparator | 2g/bottle:
* MD
* Cucumber powder Receives: Dietary Supplement: Study product D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Weight
Change of Weight in Kg by Inbody S10 from baseline to 2 months
Measured: baseline day 0, day 60
Secondary outcomes (8)
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
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Sugar Level
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval
Measured: 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
Measured: 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
Measured: 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
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces SCFA
Feces SCFA for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces sIgA
Feces sIgA for each visit interval
Measured: 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
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start6 Feb 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Precision Health Food Technology Co. Ltd.,
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Weixing Wang, MD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710055
- Sponsor's protocol ID
- 22-SM-12-WL-001
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30924853Rouxinol-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.
PubMed 32258541Perna 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.
PubMed 33669580Michael 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.
PubMed 33408364Nasiri 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.
PubMed 33487271Dechelotte 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.
PubMed 34205871Stenman 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.
PubMed 27810310Magro 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.
PubMed 25056655Waller 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.
PubMed 21663486Fuentes 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.
PubMed 23017585Guerrero-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.
PubMed 33917503
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
- ClinicalTrials.gov ID
- NCT05710055
- Acronym / sponsor ID
- 22-SM-12-WL-001
- Conditions
- Overweight
- Keywords
- Probiotics, Prebiotics, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shenzhen Precision Health Food Technology Co. Ltd.,Other government
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study product A (Wonderlab wonder4shape) | Active comparator | Dietary Supplement: 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 B (Wonderlab wonder4shape) | Active comparator | Dietary Supplement: 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 C (Wonderlab wonder4shape) | Active comparator | Dietary Supplement: 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 D | Placebo comparator | Dietary Supplement: Study product D2g/bottle: * MD * Cucumber powder |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study product A (Wonderlab wonder4shape)Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months | Dietary supplement | Study product A (Wonderlab wonder4shape) |
| Study product B (Wonderlab wonder4shape)Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months | Dietary supplement | Study product B (Wonderlab wonder4shape) |
| Study product C (Wonderlab wonder4shape)Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months | Dietary supplement | Study product C (Wonderlab wonder4shape) |
| Study product DPartipants in this arm need to consume one bottle (2g) of this product once a day for 3 months | Dietary supplement | Study product D |
Primary outcome
Change of Weight
Time frame: baseline day 0, day 60
Change of Weight in Kg by Inbody S10 from baseline to 2 months
8 secondary outcomes
Blood lipids - Total Cholesterol Level
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Sugar Level
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Hormone - Leptin Level
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Hormone - Adiponectin Level
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood inflammation
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces SCFA
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces sIgA
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Liver function test
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 30924853Suzumura 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.
- Background: PubMed 32258541Rouxinol-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.
- Background: PubMed 33669580Perna 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.
- Background: PubMed 33408364Michael 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.
- Background: PubMed 33487271Nasiri 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.
- Background: PubMed 34205871Dechelotte 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.
- Background: PubMed 27810310Stenman 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.
- Background: PubMed 25056655Magro 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.
- Background: PubMed 21663486Waller 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.
- Background: PubMed 23017585Fuentes 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.
- Background: PubMed 33917503Guerrero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weixing Wang, MD principal investigator
Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study product A (Wonderlab wonder4shape), Study product B (Wonderlab wonder4shape) and Study product C (Wonderlab wonder4shape) in people with Overweight, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Weight (time frame: baseline day 0, day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710055, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.