ObesityKOBINCT05428137
Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
A study testing Probiotic and Postbiotic in people with Obesity and Abdominal Obesity, run by The Archer-Daniels-Midland Company at 1 site in South Korea.
Trial summary
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal Obesity
- What is being tested?
- Probiotic and Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to Dec 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 25-33kg/m2
- Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
- written informed consent
Who cannot join
- Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
- taking antibiotics within 2 months before starting the study
- secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
- consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
- nicotine, drug or alcohol abuse,
- other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea St. Vincent's Hospital
Seoul
MI KYUNG KIM, Dr
Song Sang-wook, Doctor
About this study
Official title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
Read the detailed description
This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.
- Conditions
- Obesity, Abdominal Obesity
- Being tested
- Probiotic, Postbiotic, Placebo
- Medical subject headings
- Obesity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Live bacteria strain in a form of a capsule daily for 16 weeks
PostbioticDietary supplement
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
PlaceboOther
Placebo in a form of a capsule given for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Live bacteria strain in a form of a capsule daily for 16 weeks Receives: Dietary Supplement: Probiotic |
| Postbiotic | Active comparator | Heat treated bacteria strain in a form of a capsule daily for 16 weeks Receives: Dietary Supplement: Postbiotic |
| Placebo | Placebo comparator | Placebo in a form of a capsule administered for 16 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visceral fat area
Difference in visceral fat area (cm^2) measured using CT from week 0 to week 16
Measured: From week 0 to Week 16
Secondary outcomes (10)
Change in body weight
Body weight (kg) will be assessed at week 0, Week 12, Week 16
Measured: Week 0, Week 12, Week 16
Change in waist circumference
Change in waist circumference (cm) at week 0, week 12 and week 16
Measured: Week 0, Week 12, Week 16
Change in body fat composition
Change in body fat composition using dual-energy x-ray absorptiometry (DEXA) at week 0, Week 12, Week 16
Measured: Week 0, Week 12, Week 16
Change in peripheral blood cholesterol
Change in Cholesterol concentration (mg/dL) (total, HDL, LDL) in peripheral blood from week 0 to week 16
Measured: Week 0, Week 16
Change in serum insulin concentration
Change in serum insulin from week 0 to week 16
Measured: Week 0, Week 16
Change in peripheral blood glucose
Change in blood glucose from week 0 to week 16
Measured: Week 0, Week 16
Change in plasma leptin levels
Change in leptin week 0 to week 16
Measured: Week 0, Week 16
Dietary survey
Food cravings will be assessed using the Food Craving Questionnaires (FCQ) at week 0 and week 16. The change in score compared to baseline and between groups will be assessed at the end of the study.
Measured: Week 0, Week 16
Microbiome analysis
Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing
Measured: Week 0, Week 16
Mood questionnaire
Participants mood will be assessed using the PHQ-9 (Patient Health Questionnaire-9). The change in score compared to baseline and between groups will be assessed at the end of the study.
Measured: Week 0, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jul 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arm parallel design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Ramon Vidal, Study chair, ADM Biopolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428137
- Sponsor's protocol ID
- PCTB202014
- Acronym
- KOBI
- Status last verified
- Mar 2024
- First submitted
- 24 May 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
- ClinicalTrials.gov ID
- NCT05428137
- Acronym / sponsor ID
- KOBI / PCTB202014
- Conditions
- Obesity, Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Jun 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.
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
Detailed description
This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 3 arm parallel design
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticLive bacteria strain in a form of a capsule daily for 16 weeks |
| Postbiotic | Active comparator | Dietary Supplement: PostbioticHeat treated bacteria strain in a form of a capsule daily for 16 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo in a form of a capsule administered for 16 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index 25-33kg/m2
- Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
- written informed consent
Key exclusion criteria (6 listed)
- Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
- taking antibiotics within 2 months before starting the study
- secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
- consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
- nicotine, drug or alcohol abuse,
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 |
|---|---|---|
| ProbioticLive bacteria strain in a form of a capsule daily for 16 weeks | Dietary supplement | Probiotic |
| PostbioticHeat treated bacteria strain in a form of a capsule daily for 16 weeks | Dietary supplement | Postbiotic |
| PlaceboPlacebo in a form of a capsule given for 16 weeks | Other | Placebo |
Primary outcome
Change in visceral fat area
Time frame: From week 0 to Week 16
Difference in visceral fat area (cm^2) measured using CT from week 0 to week 16
10 secondary outcomes
Change in body weight
Time frame: Week 0, Week 12, Week 16
Change in waist circumference
Time frame: Week 0, Week 12, Week 16
Change in body fat composition
Time frame: Week 0, Week 12, Week 16
Change in peripheral blood cholesterol
Time frame: Week 0, Week 16
Change in serum insulin concentration
Time frame: Week 0, Week 16
Change in peripheral blood glucose
Time frame: Week 0, Week 16
Change in plasma leptin levels
Time frame: Week 0, Week 16
Dietary survey
Time frame: Week 0, Week 16
Microbiome analysis
Time frame: Week 0, Week 16
Mood questionnaire
Time frame: Week 0, Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Daniel Ramon Vidal study chair
ADM Biopolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Postbiotic in people with Obesity and Abdominal Obesity, run by The Archer-Daniels-Midland Company at 1 site in South Korea.
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 3 inclusion and 6 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 5 Mar 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 South Korea. 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 Vineetha Vijayakumar, PhD (07885966211, vineetha.vijayakumar@adm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visceral fat area (time frame: From week 0 to Week 16). 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 5 Mar 2024.