ObesityPhase 2NCT06578143
Effects of Synbiotics on Obesity
A Phase 2 study testing Synbiotics in people with Obesity, run by Leeuwenhoek Laboratories Co. Ltd..
Trial summary
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Synbiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 1 Mar 2025
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-60 years.
- Body weight ≥ 50 kg.
- Body Mass Index (BMI) ≥ 24.
- Body fat percentage ≥ 30% for females or ≥ 25% for males.
- Waist circumference ≥ 80 cm for females or ≥ 90 cm for males.
- No remarkable medical history within the past six months.
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- Willing to comply with the nutritional instructions during the study period.
- Willing to report body weight once a week.
- Willing to report dietary and activity records.
- Willing to comply with the instruction of "not using" other products containing probiotics or enzymes (excluding yogurt and yogurt drinks).
- Willing to sign Clinical Trial Informed Consent Form before the trial.
Who cannot join
- Pregnant or breastfeeding.
- Without statutory notifiable diseases, including HIV, syphilis, hepatitis B, hepatitis C, etc.
- Judged by a physician to have "secondary obesity" (obesity caused by endocrine disorders or metabolic abnormalities).
- Presence of endocrine disorders, hypertension, diabetes, cerebrovascular diseases, cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases, or mental disorders.
- Currently taking medications for lipid-lowering, blood sugar control, or weight loss.
- Currently taking antibiotic-related medications.
- Determined unsuitable for participation in this trial by a physician.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Synbiotics on Obesity and Obesity-related Parameters
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.
- Conditions
- Obesity
- Being tested
- Placebo, Synbiotics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
SynbioticsOther
Synbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: Placebo |
| Synbiotics | Experimental | Not described Receives: Other: Synbiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percentage
The difference in body fat percentage between experimental group and control group.
Measured: Up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeuwenhoek Laboratories Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578143
- Sponsor's protocol ID
- LL-IRB-2402
- Status last verified
- Oct 2024
- First submitted
- 27 Aug 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Synbiotics on Obesity and Obesity-related Parameters
- ClinicalTrials.gov ID
- NCT06578143
- Acronym / sponsor ID
- LL-IRB-2402
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Leeuwenhoek Laboratories Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 29 Aug 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.
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Placebo |
| Synbiotics | Experimental | Other: Synbiotics |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age between 20-60 years.
- Body weight ≥ 50 kg.
- Body Mass Index (BMI) ≥ 24.
- Body fat percentage ≥ 30% for females or ≥ 25% for males.
- Waist circumference ≥ 80 cm for females or ≥ 90 cm for males.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding.
- Without statutory notifiable diseases, including HIV, syphilis, hepatitis B, hepatitis C, etc.
- Judged by a physician to have "secondary obesity" (obesity caused by endocrine disorders or metabolic abnormalities).
- Presence of endocrine disorders, hypertension, diabetes, cerebrovascular diseases, cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases, or mental disorders.
- Currently taking medications for lipid-lowering, blood sugar control, or weight loss.
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 |
|---|---|---|
| PlaceboPlacebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks. | Other | Control |
| SynbioticsSynbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks. | Other | Synbiotics |
Primary outcome
Body fat percentage
Time frame: Up to six weeks
The difference in body fat percentage between experimental group and control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synbiotics in people with Obesity, run by Leeuwenhoek Laboratories Co. Ltd..
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 11 inclusion and 7 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chiwo-Wei Lin, PhD (+886-2-2377-2318 ext. #201, cwlin@lwhklab.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat percentage (time frame: Up to six weeks). 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 9 Oct 2024.