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Completed

NCT Number: NCT05710055

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.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ai'er Hospital, Shanghai, Shanghai Municipality, China

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About this study

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.

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;
  • 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.

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 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.

Treatment and study plan

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 D

Dietary Supplement

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

Primary outcomes

  1. Change of Weight

    Time frame: baseline day 0, day 60

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

Secondary outcomes

  1. Blood lipids - Total Cholesterol Level

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

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

    Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval

  3. Blood Hormone - Leptin Level

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

    Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL for each visit interval

  4. Blood Hormone - Adiponectin Level

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

    Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval

  5. Blood inflammation

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

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

  6. Feces SCFA

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

    Feces SCFA for each visit interval

  7. Feces sIgA

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

    Feces sIgA for each visit interval

  8. Liver function test

    Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

    Liver function test for each visit interval

Sponsors and collaborators

Lead sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Other Gov

Registry information

Official study title

A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
Nov 24, 2023

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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