Overweight and ObesityNCT06203834
Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects
A study testing I-Fiber Pearl in people with Overweight and Obesity, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- I-Fiber Pearl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2023to 30 Sep 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- aged 20-50 years old
- body mass index is greater than or equal to 27 kg/m2
- waist greater than or equal to 80 cm
Who cannot join
- Subjects diagnosed with cancer and on curative care.
- Subjects diagnosed with heart disease and on curative care.
- Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
- Subjects with systemic infection requiring antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects: a Randomized, Double-blind, and Placebo-controlled Trial
The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.
Read the detailed description
This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.
- Conditions
- Overweight and Obesity
- Being tested
- I-Fiber Pearl, placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-Fiber PearlDietary supplement
Eat 200g for once, and once a day.
placeboDietary supplement
Eat 200g for once, and once a day.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day. Receives: Dietary Supplement: placebo |
| I-Fiber Pearl | Experimental | I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day. Receives: Dietary Supplement: I-Fiber Pearl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body weight at week 12
Compared the difference of body weight between the week 12 and 0.
Measured: Week 0, Week 12
Change from baseline body fat at week 12
Compared the difference of body fat between the week 12 and 0.
Measured: Week 0, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Nov 2023
- Primary completion18 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- ITSWAY BIOTECH INC.
- Responsible party
- Principal investigator, Chin-Lin Hsu, Chung Shan Medical University
- Investigators
- Chin-Lin Hsu, Ph.D., Study chair, Chung Shan Medical UniversityChin-Lin Hsu, Ph.D., Principal investigator, Chung Shan Medical UniversityShiuan-Chih Chen, Dr., Principal investigator, Chung Shan Medical UniversityHung-Hsuan Kuo, Master, Principal investigator, Chung Shan Medical UniversityChun-Tse Tsai, Master, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203834
- Sponsor's protocol ID
- CS2-23093
- Status last verified
- Dec 2024
- First submitted
- 3 Jan 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects: a Randomized, Double-blind, and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06203834
- Acronym / sponsor ID
- CS2-23093
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- ITSWAY BIOTECH INC.
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Jan 2024 (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 aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.
Detailed description
This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placeboPlacebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day. |
| I-Fiber Pearl | Experimental | Dietary Supplement: I-Fiber PearlI-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female
- aged 20-50 years old
- body mass index is greater than or equal to 27 kg/m2
- waist greater than or equal to 80 cm
Key exclusion criteria (4 listed)
- Subjects diagnosed with cancer and on curative care.
- Subjects diagnosed with heart disease and on curative care.
- Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
- Subjects with systemic infection requiring antibiotics.
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 |
|---|---|---|
| I-Fiber PearlEat 200g for once, and once a day. | Dietary supplement | I-Fiber Pearl |
| placeboEat 200g for once, and once a day. | Dietary supplement | placebo |
Primary outcome
Change from baseline body weight at week 12
Time frame: Week 0, Week 12
Compared the difference of body weight between the week 12 and 0.
Change from baseline body fat at week 12
Time frame: Week 0, Week 12
Compared the difference of body fat between the week 12 and 0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
Chin-Lin Hsu, Ph.D. study chair
Chung Shan Medical University
Chin-Lin Hsu, Ph.D. principal investigator
Chung Shan Medical University
Shiuan-Chih Chen, Dr. 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 I-Fiber Pearl in people with Overweight and 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 4 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: finished, as of the sponsor's last update on 27 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body weight at week 12 (time frame: Week 0, Week 12). The study lists 2 primary outcomes in all. 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 27 Dec 2024.