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The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

Primary Purpose

Weight Reduction

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
TCI378
TCI507
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Reduction

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
  2. For those with BMI ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30%
  3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
  4. Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history).

Exclusion Criteria:

  1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
  2. Those who had undergone major surgery or bariatric surgery (according to medical history).
  3. Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo

    TCI378

    TCI507

    Arm Description

    Placebo without TCI378 and TCI507

    probiotics TCI378 (Lactobacillus plantarum TCI378)

    TCI507 (Lactobacillus plantarum TCI507)

    Outcomes

    Primary Outcome Measures

    To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2021
    Last Updated
    May 27, 2021
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04910620
    Brief Title
    The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
    Official Title
    The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2021 (Anticipated)
    Primary Completion Date
    June 14, 2024 (Anticipated)
    Study Completion Date
    June 14, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Obesity is a serious global public health issue. Many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. Clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc. TCI378 (Lactobacillus plantarum TCI378) is a probiotic extracted from Korean kimchi, and TCI507 (Lactobacillus plantarum TCI507) is a probiotic extracted from the oranges peels. These two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. Therefore, we want to evaluate whether the probiotics TCI308 and TCI507 have effects on reduction of body weight.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo without TCI378 and TCI507
    Arm Title
    TCI378
    Arm Type
    Experimental
    Arm Description
    probiotics TCI378 (Lactobacillus plantarum TCI378)
    Arm Title
    TCI507
    Arm Type
    Experimental
    Arm Description
    TCI507 (Lactobacillus plantarum TCI507)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo only
    Intervention Type
    Drug
    Intervention Name(s)
    TCI378
    Intervention Description
    TCI378 (Lactobacillus plantarum TCI378)
    Intervention Type
    Drug
    Intervention Name(s)
    TCI507
    Intervention Description
    TCI507 (Lactobacillus plantarum TCI507)
    Primary Outcome Measure Information:
    Title
    To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject. For those with BMI ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30% Those who are not pregnant and are willing to cooperate with contraception during the trial period. Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history). Exclusion Criteria: Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history). Those who had undergone major surgery or bariatric surgery (according to medical history). Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jyh-Ming Liou
    Phone
    23123456
    Ext
    63541
    Email
    jyhmingliou@gmail.com

    12. IPD Sharing Statement

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    The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

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