The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06030999 |
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Recruitment Status :
Completed
First Posted : September 11, 2023
Last Update Posted : February 21, 2024
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The goal of this interventional study is to test whether consumption of Wonderlab probiotics with prebiotics could improve obesity and overweight in Chinese people who are aged 25-45 and overweight. The main question it aims to answer is:
- whether the weight of participants can be lost after 10 weeks' intervention
150 participants will be randomized into 3 study groups (50 each group) in the two study sites, who will consume assigned product according to instructions for 10 weeks. Three site visits will be made for each participant and all relevant clinical data will be captured and recorded into CTMS(Clinical Trial Management System) for statistical analysis.
Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight and Obesity | Dietary Supplement: Study product A (Wonderlab wonder4shape) Dietary Supplement: Study product B (Wonderlab wonder4shape) Dietary Supplement: Study product C (placebo) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics |
| Actual Study Start Date : | September 18, 2023 |
| Actual Primary Completion Date : | December 2, 2023 |
| Actual Study Completion Date : | December 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Study product A (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 2.0*1010 CFU:
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Dietary Supplement: Study product A (Wonderlab wonder4shape)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks |
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Active Comparator: Study product B (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU:
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Dietary Supplement: Study product B (Wonderlab wonder4shape)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks |
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Placebo Comparator: Study product C (placebo)
2g/bottle, containing the following ingredients:
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Dietary Supplement: Study product C (placebo)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks |
- Change of Weight [ Time Frame: baseline day 0, day 70 ]Change of Weight in Kg by Inbody S10 from baseline to 10 weeks
- Blood lipids - Total Cholesterol Level [ Time Frame: baseline day 0, day 35, day 70 ]Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval
- Blood Sugar Level [ Time Frame: baseline day 0, day 35, day 70 ]Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L
- Blood hormone - Leptin level [ Time Frame: baseline day 0, day 35, day 70 ]Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL
- Blood hormone - Adiponectin level [ Time Frame: baseline day 0, day 35, day 70 ]Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL
- Blood inflammation [ Time Frame: baseline day 0, day 35, day 70 ]Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 25 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Chinese males or females, age between 25-45;
- Overweight population: BMI 24-27.9 & obesity population: BMI >=28;
- Blood lipids in high potential risks but without medication:TG > 5mmol/L or LDL >= 3.4 mmol/L or 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 enrolment.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030999
| China, Shanghai | |
| SPRIM Central Lab | |
| Shanghai, Shanghai, China | |
| China, Zhejiang | |
| Ligang Hospital | |
| Jinhua, Zhejiang, China | |
| Principal Investigator: | Hongwei Guo, MD | Shanghai Fudan University, School of Public Health | |
| Principal Investigator: | Weixing Wang, MD | Shanghai Jiao Tong University School of Medicine |
| Responsible Party: | Shenzhen Precision Health Food Technology Co. Ltd., |
| ClinicalTrials.gov Identifier: | NCT06030999 |
| Other Study ID Numbers: |
23-SM-08-WL-001 |
| First Posted: | September 11, 2023 Key Record Dates |
| Last Update Posted: | February 21, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Probiotics Prebiotics Wonderlab |
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Obesity Overweight Overnutrition Nutrition Disorders Body Weight |