AI-Crafted gut supplement put to the test for weight loss

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 65 years, inclusive. * Body mass index of 25.0 to 40.0 kg/m2 at screening. * No previous diagnosis of prediabetes or diabetes. * Glycated hemoglobin (HbA1c) below 5.7% at screening. * Fasting plasma glucose below 100 mg/dL at screening. * Stable body weight, defined as a self-reported absolute change of no more than 5% or 3 kg, whichever is smaller, during the 3 months before screening. * Willing and able to provide written informed consent. * Willing and able to comply with study visits, assigned supplement or placebo use, and the assessment schedule. * Willing to provide fasting venous blood and stool samples according to the study schedule. * Willing to receive standardized lifestyle counseling during the 24-week blinded intervention period. * No systemic antibiotic use within 8 weeks before randomization. * No probiotic, prebiotic, synbiotic, or postbiotic supplement use within 12 weeks before randomization. * If hypertension or dyslipidemia is present, antihypertensive or lipid-lowering treatment must have been initiated and the dose must have remained unchanged for at least 3 months before randomization, with no treatment change planned at the time of randomization. Exclusion Criteria: * Prediabetes or diabetes identified by medical history, HbA1c, or fasting plasma glucose. * Use of glucose-lowering medication, including metformin, a glucagon-like peptide-1 receptor agonist, a glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 co-agonist, a sodium-glucose cotransporter-2 inhibitor, a dipeptidyl peptidase-4 inhibitor, a sulfonylurea, insulin, or another antidiabetic agent. * Use of a glucagon-like peptide-1 receptor agonist or glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 co-agonist for any indication within 12 months before randomization. * Use of another anti-obesity medication, including orlistat, naltrexone/bupropion, or phentermine/topiramate, within 6 months before randomization. * Planned initiation during the 24-week study of a weight-loss medication, structured commercial weight-loss program, very-low-calorie diet, or bariatric procedure. * History of bariatric surgery. * History of gastrointestinal surgery other than appendectomy or uncomplicated cholecystectomy. * Active inflammatory bowel disease, celiac disease, microscopic colitis, chronic pancreatitis, malabsorption syndrome, or another chronic severe gastrointestinal disease likely to affect nutrient absorption or study adherence. * Acute gastroenteritis within 4 weeks before randomization. * Colonoscopy bowel preparation within 12 weeks before randomization. * Fecal microbiota transplantation within 12 months before randomization. * Active malignancy or malignancy treated within 6 months before screening, except adequately treated non-melanoma skin cancer. * Stage 3b to 5 chronic kidney disease, defined as an estimated glomerular filtration rate below 45 mL/min/1.73 m2. * Decompensated liver disease or Child-Pugh class B or C liver disease. * Alanine aminotransferase or aspartate aminotransferase greater than 3 times the upper limit of normal at screening, unless judged clinically insignificant and approved by the investigator. * Untreated overt thyroid disease, or initiation or dose modification of thyroid medication within 3 months before randomization. Stable treated hypothyroidism is permitted. * Use of systemic corticosteroids within 4 weeks before randomization. * Use of immunosuppressive medication or biologic or immunomodulatory therapy within 5 half-lives before randomization. * Pregnancy or lactation. * For participants of childbearing potential, unwillingness to use effective contraception during the 24-week blinded intervention period. * Severe psychiatric illness or cognitive impairment that, in the investigator's judgment, would impair informed consent, participant safety, or adherence to study procedures. * Active eating disorder, defined as at least 2 affirmative responses on the SCOFF screening questionnaire or a clinical diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder. * Heavy alcohol use or active substance use disorder. * Current use of a very-low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or another highly restrictive diet that excludes major food groups. * Current cigarette smoking with a stated intention to attempt smoking cessation during the 24-week study, or initiation of nicotine-replacement or other smoking-cessation pharmacotherapy within 3 months before randomization. * Participation in another interventional clinical study within 30 days before screening. * Known hypersensitivity or clinically significant intolerance to any component of the active supplement or placebo. * Any condition that, in the investigator's judgment, would compromise participant safety, adherence, or study integrity.