ObesityObelixNCT05440630
Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals
A study testing Probiotics and Postbiotic in people with Obesity, run by The Archer-Daniels-Midland Company at 1 site in Mexico.
Trial summary
The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Probiotics and Postbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2022to 30 Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects from 18 to 65 years old.
- Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)
- Waist circumference ≥ 102 cm for men
- Waist circumference ≥ 88 cm for women
- Signature of the informed consent letter.
- Agreement to comply with the protocol and study restrictions
Who cannot join
- Diagnosed and pharmacologically-treated type 1 or type 2 diabetes
- Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease
- Immunosuppression or ongoing therapy causing immunosuppression
- Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia
- Subjects consuming antibiotics in the previous 2 months
- Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
Show all 10Show fewer
- History of chronic active inflammatory disorders
- History of bariatric surgery
- History of any chronic gastrointestinal disease (e.g. IBD).
- Known hypersensitivity to any ingredients in the active or placebo products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Probiotic Strain Bifidobacterium Animalis Subsp. Lactis CECT 8145 Probiotic in the Reduction of Abdominal/Visceral Fat in Overweight and Obese Patients: Double-blind, Randomised, Placebo-controlled Trial
The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.
Read the detailed description
Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.
- Conditions
- Obesity
- Being tested
- Probiotics, Postbiotic, 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
Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks.
PostbioticDietary supplement
Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain postbiotic (Heat treated bacteria) for 16 weeks.
PlaceboDietary supplement
Participants in this arm will receive an equivalent placebo for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks. Receives: Dietary Supplement: Probiotics |
| Postbiotic | Experimental | Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (Heat treated bacteria) for 16 weeks. Receives: Dietary Supplement: Postbiotic |
| Placebo | Placebo comparator | Participants in this arm will receive an equivalent placebo for 16 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal/visceral fat area
Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups.
Measured: 0 week to 16 week
Secondary outcomes (10)
Change in abdominal subcutaneous fat area
Difference in abdominal subcutaneous fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups.
Measured: 0 week to 16 week
Change in body composition
Difference in total body fat mass (kg) from baseline to 4 months of product intake within and between groups (relative and absolute, measured by bioelectrical impedance at V1 and V4).
Measured: 0 week to 16 week
Change in body weight
Body weight change (percent and kg) at all visits - difference within and between groups.
Measured: week 0, week 4, week 8, week 16
Change in BMI
BMI change (units and percent) at all visits - difference within and between groups.
Measured: week 0, week 4, week 8, week 16
Change in waist circumference
Change in waist circumference (all visits V1-4)
Measured: week 0, week 4, week 8, week 16
Change in hip circumference
Change in hip circumference at all visits difference within and between groups (absolute and relative)
Measured: week 0, week 4, week 8, week 16
Change in lipid profile
Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months)
Measured: week 0, week 16
Change in systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure (mmHg)
Measured: week 0, week 4, week 8, week 16
Changes in glucose profile
Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5)
Measured: week 0, week 16
Change in cortisol levels
Change in cortisol levels (nmol/L)
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 posted1 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Why it stopped: Unable to ship investigational product to trial site.
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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nois de México
- Responsible party
- Sponsor
- Investigators
- Joshue Covarrubia Esquer, Dr, Principal investigator, NOIS DE MEXICO S.A. DE C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440630
- Sponsor's protocol ID
- PCTB202015
- Acronym
- Obelix
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2022
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Probiotic Strain Bifidobacterium Animalis Subsp. Lactis CECT 8145 Probiotic in the Reduction of Abdominal/Visceral Fat in Overweight and Obese Patients: Double-blind, Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05440630
- Acronym / sponsor ID
- Obelix / PCTB202015
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to ship investigational product to trial site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Nois de México
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 1 Jul 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 study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.
Detailed description
Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticsParticipants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks. |
| Postbiotic | Experimental | Dietary Supplement: PostbioticParticipants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (Heat treated bacteria) for 16 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive an equivalent placebo for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects from 18 to 65 years old.
- Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)
- Waist circumference ≥ 102 cm for men
- Waist circumference ≥ 88 cm for women
- Signature of the informed consent letter.
Key exclusion criteria (10 listed)
- Diagnosed and pharmacologically-treated type 1 or type 2 diabetes
- Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease
- Immunosuppression or ongoing therapy causing immunosuppression
- Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia
- Subjects consuming antibiotics in the previous 2 months
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 |
|---|---|---|
| ProbioticsParticipants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks. | Dietary supplement | Probiotic |
| PostbioticParticipants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain postbiotic (Heat treated bacteria) for 16 weeks. | Dietary supplement | Postbiotic |
| PlaceboParticipants in this arm will receive an equivalent placebo for 16 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in abdominal/visceral fat area
Time frame: 0 week to 16 week
Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups.
10 secondary outcomes
Change in abdominal subcutaneous fat area
Time frame: 0 week to 16 week
Change in body composition
Time frame: 0 week to 16 week
Change in body weight
Time frame: week 0, week 4, week 8, week 16
Change in BMI
Time frame: week 0, week 4, week 8, week 16
Change in waist circumference
Time frame: week 0, week 4, week 8, week 16
Change in hip circumference
Time frame: week 0, week 4, week 8, week 16
Change in lipid profile
Time frame: week 0, week 16
Change in systolic and diastolic blood pressure
Time frame: week 0, week 4, week 8, week 16
Changes in glucose profile
Time frame: week 0, week 16
Change in cortisol levels
Time frame: week 0, week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- 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.
Joshue Covarrubia Esquer, Dr principal investigator
NOIS DE MEXICO S.A. DE C.V.
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 and Postbiotic in people with Obesity, run by The Archer-Daniels-Midland Company at 1 site in Mexico.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Mar 2025. 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 Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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 in abdominal/visceral fat area (time frame: 0 week to 16 week). 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 6 Mar 2025.