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NCT Number: NCT06030999

The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

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.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SPRIM Central Lab, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study product A (Wonderlab wonder4shape)

Dietary Supplement

Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks

Study product B (Wonderlab wonder4shape)

Dietary Supplement

Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks

Study product C (placebo)

Dietary Supplement

Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks

Primary outcomes

  1. Change of Weight

    Time frame: baseline day 0, day 70

    Change of Weight in Kg by Inbody S10 from baseline to 10 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Blood inflammation

    Time frame: baseline day 0, day 35, day 70

    Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)

Sponsors and collaborators

Lead sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Other Gov

Registry information

Official study title

Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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