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Official title A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health
ClinicalTrials.gov ID: NCT06911073
What this study is testing
- What it's testing
- This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
- 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.
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.