Obesity and OverweightNCT06911073
A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health
A study testing Postbiotic in people with Obesity and Overweight, run by ResBiotic Nutrition, Inc. at 1 site in United States.
Trial summary
This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Postbiotic
- 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
- 1 siteUnited States
- Study dates
- 2 May 2025to 1 Mar 2026
- 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
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history.
- Age between 18 and 65 yr (inclusive).
- Body Mass Index of 25.0 - 40.0 (inclusive).
- Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- Agree to refrain from other probiotic and postbiotic supplement products throughout the duration of the trial.
- Subject is willing and able to comply with the study protocol.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- Alcohol abuse (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- Previous bariatric surgery.
- Current smokers or smoking within the past month.
- History of hyperparathyroidism or an untreated thyroid condition.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
Show all 12Show fewer
- Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- Previous medical diagnosis of gout or fibromyalgia.
- Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Any woman that is sexually active will have to take report their pregnancy status prior to enrolling and during the trial if they become pregnant.
- Known sensitivity to any ingredient in the test formulations as listed in the product label.
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized Placebo-Controlled Study to Evaluate a Postbiotic Supplement in Supporting Weight Loss and Metabolic Health
This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.
Read the detailed description
Obesity poses substantial health challenges contributing significantly to chronic metabolic disorders such as type 2 diabetes mellitus, cardiovascular disease, and diminished quality of life for people worldwide. Central to obesity-related metabolic dysfunction is dysregulation of appetite control, glucose homeostasis, insulin sensitivity, and systemic inflammation. Evidence indicates a strong connection between these metabolic disturbances and alterations in the gut microbiome, implicating microbiota dysbiosis as a potential target for intervention. Microbiome-based interventions underscore a promising approach in weight management and metabolic health.
- Conditions
- Obesity and Overweight
- Being tested
- Postbiotic, Placebo
- Keywords
- Postbiotic, Obesity, GLP-1, Metabolic health
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDietary supplement
Also called resM™ GLP-1 Postbiotic
Active ingredients:
Vitamin D (as cholecalciferol) - 10 mcg Vitamin B12 (as methylcobalamin) - 200 mcg Chromium (as chromium picolinate) - 600 mcg resM™ Postbiotic (L. plantarum RSB11® HI - 16B cells) - 40 mg White mulberry (Morus alba) leaf extract - 250 mg Fenugreek (Trigonella foenum-graecum) seed extract - 200 mg
Inactive ingredients:
Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate
PlaceboDietary supplement
Active ingredients:
N/A
Inactive ingredients:
Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 capsule of placebo, taken once daily Receives: Dietary Supplement: Placebo |
| Postbiotic Supplement | Experimental | 1 capsule of 40 mg postbiotic, 450 mg herbal blend, and 810 mcg vitamins taken once daily Receives: Dietary Supplement: Postbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of resM™ on weight
Change from baseline in weight (lb)
Measured: 8 weeks
To determine the effect of resM™ on BMI
Change from baseline in BMI. Weight and height will be combined to report BMI in kg/m^2)
Measured: 8 weeks
To determine the effect of resM™ on food cravings
Change in reported food cravings from baseline based on Food Craving Questionnaire Trait-reduced (FCQ-T-r) scores. The total score reflects the severity of food cravings where 90 indicates the most severe and 15 indicates the least severe.
Measured: 8 weeks
To determine the effect of resM™ on blood metabolic markers
Change from baseline in serum fasting glucose
Measured: 8 weeks
To determine the effect of resM™ on blood metabolic markers
Change from baseline in serum insulin levels
Measured: 8 weeks
To determine the effect of resM™ on blood metabolic markers
Change from baseline in whole blood HbA1c (glycated hemoglobin)
Measured: 8 weeks
Secondary outcomes (34)
To determine the effect of resM™ on GLP-1
Change from baseline in plasma active and inactive GLP-1 protein
Measured: 8 weeks
To determine the effect of resM™ on DPP-4
Change from baseline in plasma DPP4
Measured: 8 weeks
To determine the effect of resM™ on gut microbiome
Change from baseline in gut microbiome as assessed by 16s metagenomic sequencing on fecal samples
Measured: 8 weeks
To determine the effect of resM™ on depression
Change from baseline in reported depression levels based on Patient Health Questionnaire 9 (PHQ-9) scores. The total score reflects the severity of depression where 1 indicates minimal depression and 27 indicates severe depression.
Measured: 8 weeks
Change in Albumin after taking resM™
Change from baseline in Albumin
Measured: 8 weeks
Change in Albumin/Globulin ratio after taking resM™
Change from baseline in Albumin/Globulin ratio
Measured: 8 weeks
Change in Alkaline Phosphatase after taking resM™
Change from baseline in Alkaline Phosphatase
Measured: 8 weeks
Change in Alanine Aminotransferase (ALT) after taking resM™
Change from baseline in Alanine Aminotransferase (ALT)
Measured: 8 weeks
Change in Aspartate Aminotransferase (AST) after taking resM™
Change from baseline in Aspartate Aminotransferase (AST)
Measured: 8 weeks
Change in BUN/Creatinine ratio after taking resM™
Change from baseline in blood urea nitrogen (BUN)/creatinine ratio
Measured: 8 weeks
Change in Calcium after taking resM™
Change from baseline in calcium
Measured: 8 weeks
Change in Chloride after taking resM™
Change from baseline in chloride
Measured: 8 weeks
Change in Glucose after taking resM™
Change from baseline in glucose
Measured: 8 weeks
Change in Sodium after taking resM™
Change from baseline in sodium
Measured: 8 weeks
Change in Total Bilirubin after taking resM™
Change from baseline in total bilirubin
Measured: 8 weeks
Change in Total Protein after taking resM™
Change from baseline in total protein
Measured: 8 weeks
Change in Urea Nitrogen after taking resM™
Change from baseline in Urea Nitrogen
Measured: 8 weeks
Change in White Blood Cell (WBC) count after taking resM™
Change from baseline in white blood cell (WBC) count
Measured: 8 weeks
Change in Red Blood Cell (RBC) count after taking resM™
Change from baseline in red blood cell (RBC) count
Measured: 8 weeks
Change in Hemoglobin (Hb) after taking resM™
Change from baseline in hemoglobin (Hb)
Measured: 8 weeks
Change in Hematocrit (Hct) after taking resM™
Change from baseline in hematocrit (Hct)
Measured: 8 weeks
Change in Mean Corpuscular Volume (MCV) after taking resM™
Change from baseline in mean corpuscular volume (MCV)
Measured: 8 weeks
Change in Mean Corpuscular Hemoglobin (MCH) after taking resM™
Change from baseline in mean corpuscular hemoglobin (MCH)
Measured: 8 weeks
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resM™
Change from baseline in mean corpuscular hemoglobin concentration (MCHC)
Measured: 8 weeks
Change in Red Cell Distribution Width (RDW) after taking resM™
Change from baseline in red cell distribution width (RDW)
Measured: 8 weeks
Change in Platelet Count after taking resM™
Change from baseline in platelet count
Measured: 8 weeks
Change in Mean Platelet Volume (MPV) after taking resM™
Change from baseline in Mean Platelet Volume (MPV)
Measured: 8 weeks
Change in Neutrophils after taking resM™
Change from baseline in neutrophil count (absolute) and differential (percent)
Measured: 8 weeks
Change in Lymphocytes after taking resM™
Change from baseline in lymphocyte count (absolute) and differential (percent)
Measured: 8 weeks
Change in Monocytes after taking resM™
Change from baseline in monocyte count (absolute) and differential (percent)
Measured: 8 weeks
Change in Eosinophils after taking resM™
Change from baseline in eosinophil count (absolute) and differential (percent)
Measured: 8 weeks
Change in Basophils after taking resM™
Change from baseline in basophil count (absolute) and differential (percent)
Measured: 8 weeks
Safety - participants experiencing adverse events
The number of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Measured: 8 weeks
Safety - total adverse events
The total number of Treatment Emergent Adverse Events (TEAEs)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start2 May 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization at 1:1 ratio of active:placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResBiotic Nutrition, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Able Biolabs, LLC
- Responsible party
- Sponsor
- Investigators
- Ahmed Abdelgawad, MD, Principal investigator, Able Biolabs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911073
- Sponsor's protocol ID
- ABL-032501
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2025
- Last updated
- 14 Aug 2026
- 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Placebo-Controlled Study to Evaluate a Postbiotic Supplement in Supporting Weight Loss and Metabolic Health
- ClinicalTrials.gov ID
- NCT06911073
- Acronym / sponsor ID
- ABL-032501
- Conditions
- Obesity and Overweight
- Keywords
- Postbiotic, Obesity, GLP-1, Metabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ResBiotic Nutrition, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Able Biolabs, LLC
- Study start
- 2 May 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 4 Apr 2025 (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.
This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.
Detailed description
Obesity poses substantial health challenges contributing significantly to chronic metabolic disorders such as type 2 diabetes mellitus, cardiovascular disease, and diminished quality of life for people worldwide. Central to obesity-related metabolic dysfunction is dysregulation of appetite control, glucose homeostasis, insulin sensitivity, and systemic inflammation. Evidence indicates a strong connection between these metabolic disturbances and alterations in the gut microbiome, implicating microbiota dysbiosis as a potential target for intervention. Microbiome-based interventions underscore a promising approach in weight management and metabolic health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization at 1:1 ratio of active:placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule of placebo, taken once daily |
| Postbiotic Supplement | Experimental | Dietary Supplement: Postbiotic1 capsule of 40 mg postbiotic, 450 mg herbal blend, and 810 mcg vitamins taken once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history.
- Age between 18 and 65 yr (inclusive).
- Body Mass Index of 25.0 - 40.0 (inclusive).
- Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
Key exclusion criteria (12 listed)
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- Alcohol abuse (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- Previous bariatric surgery.
- Current smokers or smoking within the past month.
- History of hyperparathyroidism or an untreated thyroid condition.
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 |
|---|---|---|
| PostbioticAlso: resM™ GLP-1 PostbioticActive ingredients: Vitamin D (as cholecalciferol) - 10 mcg Vitamin B12 (as methylcobalamin) - 200 mcg Chromium (as chromium picolinate) - 600 mcg resM™ Postbiotic (L. plantarum RSB11® HI - 16B cells) - 40 mg White mulberry (Morus alba) leaf extract - 250 mg Fenugreek (Trigonella foenum-graecum) seed extract - 200 mg Inactive ingredients: Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate | Dietary supplement | Postbiotic Supplement |
| PlaceboActive ingredients: N/A Inactive ingredients: Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate | Dietary supplement | Placebo |
Primary outcome
To determine the effect of resM™ on weight
Time frame: 8 weeks
Change from baseline in weight (lb)
To determine the effect of resM™ on BMI
Time frame: 8 weeks
Change from baseline in BMI. Weight and height will be combined to report BMI in kg/m^2)
To determine the effect of resM™ on food cravings
Time frame: 8 weeks
Change in reported food cravings from baseline based on Food Craving Questionnaire Trait-reduced (FCQ-T-r) scores. The total score reflects the severity of food cravings where 90 indicates the most severe and 15 indicates the least severe.
To determine the effect of resM™ on blood metabolic markers
Time frame: 8 weeks
Change from baseline in serum fasting glucose
To determine the effect of resM™ on blood metabolic markers
Time frame: 8 weeks
Change from baseline in serum insulin levels
To determine the effect of resM™ on blood metabolic markers
Time frame: 8 weeks
Change from baseline in whole blood HbA1c (glycated hemoglobin)
34 secondary outcomes
To determine the effect of resM™ on GLP-1
Time frame: 8 weeks
To determine the effect of resM™ on DPP-4
Time frame: 8 weeks
To determine the effect of resM™ on gut microbiome
Time frame: 8 weeks
To determine the effect of resM™ on depression
Time frame: 8 weeks
Change in Albumin after taking resM™
Time frame: 8 weeks
Change in Albumin/Globulin ratio after taking resM™
Time frame: 8 weeks
Change in Alkaline Phosphatase after taking resM™
Time frame: 8 weeks
Change in Alanine Aminotransferase (ALT) after taking resM™
Time frame: 8 weeks
Change in Aspartate Aminotransferase (AST) after taking resM™
Time frame: 8 weeks
Change in BUN/Creatinine ratio after taking resM™
Time frame: 8 weeks
Change in Calcium after taking resM™
Time frame: 8 weeks
Change in Chloride after taking resM™
Time frame: 8 weeks
Change in Glucose after taking resM™
Time frame: 8 weeks
Change in Sodium after taking resM™
Time frame: 8 weeks
Change in Total Bilirubin after taking resM™
Time frame: 8 weeks
Change in Total Protein after taking resM™
Time frame: 8 weeks
Change in Urea Nitrogen after taking resM™
Time frame: 8 weeks
Change in White Blood Cell (WBC) count after taking resM™
Time frame: 8 weeks
Change in Red Blood Cell (RBC) count after taking resM™
Time frame: 8 weeks
Change in Hemoglobin (Hb) after taking resM™
Time frame: 8 weeks
Change in Hematocrit (Hct) after taking resM™
Time frame: 8 weeks
Change in Mean Corpuscular Volume (MCV) after taking resM™
Time frame: 8 weeks
Change in Mean Corpuscular Hemoglobin (MCH) after taking resM™
Time frame: 8 weeks
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resM™
Time frame: 8 weeks
Change in Red Cell Distribution Width (RDW) after taking resM™
Time frame: 8 weeks
Change in Platelet Count after taking resM™
Time frame: 8 weeks
Change in Mean Platelet Volume (MPV) after taking resM™
Time frame: 8 weeks
Change in Neutrophils after taking resM™
Time frame: 8 weeks
Change in Lymphocytes after taking resM™
Time frame: 8 weeks
Change in Monocytes after taking resM™
Time frame: 8 weeks
Change in Eosinophils after taking resM™
Time frame: 8 weeks
Change in Basophils after taking resM™
Time frame: 8 weeks
Safety - participants experiencing adverse events
Time frame: 8 weeks
Safety - total adverse events
Time frame: 8 weeks
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 14 Aug 2026.
- 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.
Ahmed Abdelgawad, MD principal investigator
Able Biolabs, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic in people with Obesity and Overweight, run by ResBiotic Nutrition, Inc. at 1 site in United States.
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 8 inclusion and 12 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 14 Aug 2026. 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 United States. 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?
To determine the effect of resM™ on weight (time frame: 8 weeks). The study lists 6 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 14 Aug 2026.