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Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants

Primary Purpose

Body Weight, Body Fat, Overweight

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vigiis 101 Lactobacillus Capsules
Placebo Capsules
Sponsored by
SunWay Biotech Co., LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects are 20-65-year-old men or non-pregnant women (women of childbearing age are not allowed to become pregnant or breastfeed during the study) and adult volunteers who are conscious and able to communicate. Subjects with a body mass index (BMI) between 23 and 29.9 (kg/m2 ) and classified as overweight according to the World Health Organization Asia-Pacific criteria. Subjects who agree to participate in this trial and voluntarily agree to the test consent in writing. Exclusion Criteria: Subjects who are pregnant or lactating or expecting pregnancy. Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery. Subjects suffering from high blood pressure (≥160/100 mmHg, after resting for 10 minutes) or taking diuretics. Subjects with diabetes (fasting blood glucose (≥125 mg/dL). Suffering from heart disease, liver and kidney insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumor or any other diseases that affect the research results. Suffering from depression, schizophrenia, alcoholism, drug addiction and other mental disorders or taking drugs (such as psychotropic drugs, β receptor blockers). Subjects have taken drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional foods within 2 weeks before the screening visit. Subjects judged to be unable to exercise due to severe musculoskeletal diseases. Subjects who consumed probiotics or expected to consume probiotics within 2 weeks before the screening visit. Subjects who have participated in or are expected to participate in clinical trials within 4 weeks before the screening visit. The withdrawal criteria are as follows: (1) Unable to take the test sample on time (i.e. more than 7 days out of every 4 weeks without taking the sample) (2) Unable to cooperate with the return visit on time (after being contacted or lost contact, 7 days beyond the expected return visit time) (2) If the subject chooses to voluntarily stop participating due to personal reasons. (3) Serious violations of the research protocol. (4) Taking drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional health food with probiotics in the experiment. (5) When severe adverse reactions occur clinically. (6) The aforementioned "subject exclusion conditions" did not occur during the screening period, and must be withdrawn if they occur during the trial. (7) Other situations where continuing to participate in the research will endanger the health of the subject. When there is important new information during the execution of the trial (referring to your rights or affecting your willingness to continue participating), you will be notified and further explained. Please reconsider whether to continue participating. You can decide freely and will not cause any discomfort. Or affect their future physicians to your medical care. (8) The project host or the sponsor may also suspend the entire experiment if necessary.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vigiis 101 Lactobacillus Capsules

    Placebo Capsules

    Arm Description

    Vigiis 101 Lactic Acid Bacteria Capsules is a commercially available product for Lactobacillus paracasei subspecies paracasei NTU 101 (NTU 101) is a strain of Lactobacillus isolated from the intestinal tract of newborns in Taiwan. 10 billion CFU/cap of NTU 101 freeze-dried powder (production research and development: Chenhui Biotechnology Co., Ltd. Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in vegetable capsules were prepared.

    Maltodextrin was used as a placebo.

    Outcomes

    Primary Outcome Measures

    BMI improvement
    Improvement in BMI from baseline was used as the primary outcome.

    Secondary Outcome Measures

    Other body index improvements
    The secondary outcome was the improvement in body fat percentage (measured in %).

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    May 18, 2023
    Sponsor
    SunWay Biotech Co., LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05869799
    Brief Title
    Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants
    Official Title
    Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants: a Randomized, Double-blinded, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SunWay Biotech Co., LTD.

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
    Detailed Description
    Subjects meeting the inclusion criteria were randomly assigned to 2 groups (Vigiis 101 lactic acid bacteria: n = 50, placebo: n = 50) in a 1:1 ratio, Block : 4 randomization. Randomization was performed by a research statistician not directly involved in the trial. Researchers and subjects were unaware of treatment groups until data analysis was complete. During the 12-week use trial, subjects were asked to take Vigiis 101 Lactobacillus capsules or a placebo once a day before breakfast. The subjects were required to maintain a regular lifestyle and recorded daily Vigiis 101 Lactobacillus or placebo consumption, diet and the number of steps walked as a measure of physical activity. Body composition, anthropometric and biochemical measurements were measured at weeks 0, 4, 8, and 12 after consumption initiation. Clinical exams are done every 4 weeks in the hospital. Subjects filled out daily diaries that included questions about study product intake, other food intake, number of bowel movements, stool quality (consistency and color), any medications received, and any uncomfortable symptoms such as diarrhea, constipation, Vomiting, flatulence, discomfort, etc.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Weight, Body Fat, Overweight

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    This experiment adopts a block random assignment design, and the system assignment table (Block randomization, block size = 6) randomly generated by the program is given serial numbers and assigned to groups. The probability of assignment to each group is 1/2.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vigiis 101 Lactobacillus Capsules
    Arm Type
    Experimental
    Arm Description
    Vigiis 101 Lactic Acid Bacteria Capsules is a commercially available product for Lactobacillus paracasei subspecies paracasei NTU 101 (NTU 101) is a strain of Lactobacillus isolated from the intestinal tract of newborns in Taiwan. 10 billion CFU/cap of NTU 101 freeze-dried powder (production research and development: Chenhui Biotechnology Co., Ltd. Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in vegetable capsules were prepared.
    Arm Title
    Placebo Capsules
    Arm Type
    Placebo Comparator
    Arm Description
    Maltodextrin was used as a placebo.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vigiis 101 Lactobacillus Capsules
    Intervention Description
    Product ingredients: microcrystalline cellulose, corn starch, NTU 101 lactic acid bacteria powder (1.0 x 10^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Capsules
    Intervention Description
    Maltodextrin was used as a placebo
    Primary Outcome Measure Information:
    Title
    BMI improvement
    Description
    Improvement in BMI from baseline was used as the primary outcome.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Other body index improvements
    Description
    The secondary outcome was the improvement in body fat percentage (measured in %).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects are 20-65-year-old men or non-pregnant women (women of childbearing age are not allowed to become pregnant or breastfeed during the study) and adult volunteers who are conscious and able to communicate. Subjects with a body mass index (BMI) between 23 and 29.9 (kg/m2 ) and classified as overweight according to the World Health Organization Asia-Pacific criteria. Subjects who agree to participate in this trial and voluntarily agree to the test consent in writing. Exclusion Criteria: Subjects who are pregnant or lactating or expecting pregnancy. Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery. Subjects suffering from high blood pressure (≥160/100 mmHg, after resting for 10 minutes) or taking diuretics. Subjects with diabetes (fasting blood glucose (≥125 mg/dL). Suffering from heart disease, liver and kidney insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumor or any other diseases that affect the research results. Suffering from depression, schizophrenia, alcoholism, drug addiction and other mental disorders or taking drugs (such as psychotropic drugs, β receptor blockers). Subjects have taken drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional foods within 2 weeks before the screening visit. Subjects judged to be unable to exercise due to severe musculoskeletal diseases. Subjects who consumed probiotics or expected to consume probiotics within 2 weeks before the screening visit. Subjects who have participated in or are expected to participate in clinical trials within 4 weeks before the screening visit. The withdrawal criteria are as follows: (1) Unable to take the test sample on time (i.e. more than 7 days out of every 4 weeks without taking the sample) (2) Unable to cooperate with the return visit on time (after being contacted or lost contact, 7 days beyond the expected return visit time) (2) If the subject chooses to voluntarily stop participating due to personal reasons. (3) Serious violations of the research protocol. (4) Taking drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional health food with probiotics in the experiment. (5) When severe adverse reactions occur clinically. (6) The aforementioned "subject exclusion conditions" did not occur during the screening period, and must be withdrawn if they occur during the trial. (7) Other situations where continuing to participate in the research will endanger the health of the subject. When there is important new information during the execution of the trial (referring to your rights or affecting your willingness to continue participating), you will be notified and further explained. Please reconsider whether to continue participating. You can decide freely and will not cause any discomfort. Or affect their future physicians to your medical care. (8) The project host or the sponsor may also suspend the entire experiment if necessary.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Lin
    Phone
    02-27929568
    Ext
    612
    Email
    sean.lin@sunway.cc
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    WEN-HUI FANG, Ph. D.
    Organizational Affiliation
    Chief of Family medicine department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    35208906
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    Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants

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