ObesityNCT05607524
Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial
A study testing probiotics in people with Obesity, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Sep 2022to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female participants
- aged 20-40 years old
- body mass index in 25-27 kg/m2
- body fat > 25% for men and > 30% for women
Who cannot join
- cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity
- having systemic infections
- using probiotics.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University
Taichung, South, 402
Chin-Lin Hsu, Professor, 04-24730022 ext. 12222, clhsu@csmu.edu.tw
About this study
Official title: Effects of Grape King Bio Probiotic Capsules in Promoting Fat Excretion by Human Trial
The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test.
Read the detailed description
This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 60 subjects were randomized, 20 to placebo and 40 to probiotics. The subjects took two capsules of Grape King probiotics daily, a total of 1000 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.
- Conditions
- Obesity
- Being tested
- probiotics, placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
Eat a capsule for once, and twice a day
placeboDietary supplement
Eat a capsule for once, and twice a day
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Probiotic capsules, 500 mg each, two daily for a total of 1000 mg for 4 weeks Receives: Dietary Supplement: probiotics |
| Placebo | Placebo comparator | The placebo capsules had the same composition as the experimental capsules, except that they did not contain probiotics, and should be used for 4 weeks. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fecel lipid weight at week 4
Compared the difference of fecel lipid weight level between the week 4 and 0
Measured: Week0, Week4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start29 Sep 2022
- Primary completion29 Dec 2022 (estimated)
- Study completion16 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Principal investigator, Chin-Lin Hsu, Chung Shan Medical University
- Investigators
- Yu-Jou Chien, PhD student, Principal investigator, Chung Shan Medical UniversityXin-Bei Lin, MS student, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607524
- Sponsor's protocol ID
- CS2-22068
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Grape King Bio Probiotic Capsules in Promoting Fat Excretion by Human Trial
- ClinicalTrials.gov ID
- NCT05607524
- Acronym / sponsor ID
- CS2-22068
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 29 Dec 2022 (estimated)
- Study completion
- 16 Jan 2023 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test.
Detailed description
This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 60 subjects were randomized, 20 to placebo and 40 to probiotics. The subjects took two capsules of Grape King probiotics daily, a total of 1000 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: probioticsProbiotic capsules, 500 mg each, two daily for a total of 1000 mg for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: placeboThe placebo capsules had the same composition as the experimental capsules, except that they did not contain probiotics, and should be used for 4 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male or female participants
- aged 20-40 years old
- body mass index in 25-27 kg/m2
- body fat > 25% for men and > 30% for women
Key exclusion criteria (3 listed)
- cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity
- having systemic infections
- using probiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticsEat a capsule for once, and twice a day | Dietary supplement | Probiotics |
| placeboEat a capsule for once, and twice a day | Dietary supplement | Placebo |
Primary outcome
Change from baseline fecel lipid weight at week 4
Time frame: Week0, Week4
Compared the difference of fecel lipid weight level between the week 4 and 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Jou Chien, PhD student principal investigator
Chung Shan Medical University
Xin-Bei Lin, MS student principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Obesity, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Lin Hsu, Professor (04-24730022 ext. 12222, clhsu@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline fecel lipid weight at week 4 (time frame: Week0, Week4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.