Daily postbiotic gummy plus nutrition advice for adults with overweight or obesity
Clinical Evaluation of a Postbiotic Supplement in Overweight and Obese Subjects: A Randomized Controlled Trial.
This project will test whether taking a daily postbiotic gummy together with nutritional advice helps adults with overweight or obesity improve body composition, glucose metabolism, and gut microbiota.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Locations | 1 site (Pamplona, Navarre) |
| Trial ID | NCT07165431 on ClinicalTrials.gov |
What this trial studies
Volunteers aged 18–70 with overweight or obesity will be screened online and invited for an information visit before signing consent and being randomly assigned to receive either a postbiotic gummy or a placebo alongside standardized nutritional recommendations for 12 weeks. Clinical visits occur at baseline and at the end of the 12-week intervention, with measurements of body composition, blood pressure, and collection of blood, urine, and stool samples. The study will analyze changes in body weight and composition, glucose tolerance, routine biochemical markers, specific obesity-related hormones and cytokines, urinary and serum metabolites, and gut microbiota via metagenomics. Adherence to the nutritional advice and daily gummy will be tracked, and diet, physical activity, sleep, and gastrointestinal symptoms will be recorded.
Who should consider this trial
Good fit: Adults 18–70 years old with BMI 27–39.9 kg/m² and body fat ≥30% (women) or ≥20% (men), stable weight for at least three months, able to comply with visits and daily gummy intake, and not taking insulin or other hypoglycemic drugs are ideal candidates.
Not a fit: People outside the BMI/body fat criteria, those on insulin or hypoglycemic medications, pregnant individuals, or those with unstable medical conditions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the postbiotic gummy could provide a safe, non-live microbial approach to reduce body fat and improve metabolic and gut-related markers in people with overweight or obesity.
How similar studies have performed: Small trials of postbiotics and heat-killed probiotic preparations have shown promising effects on metabolism and microbiota, but large randomized trials in overweight adults are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants aged 18 to 70 years. * Volunteers with overweight or obesity (BMI: ≥ 27-39.9 kg/m²) and a body fat percentage of ≥ 30% for women and ≥ 20% for men. * Stable body weight (±5%) for at least the three months prior to study initiation. * Normal physical examination and vital signs, or clinically non-relevant findings for the purposes of the study (i.e., not related to metabolic health). * Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements. * Continued pharmacological/hormonal treatment will be permitted provided it does not affect the study parameters and that the dosage has remained stable at least the previous three months to the start of the intervention. Treatment with insulin or any drug with a hypoglycemic effect will be excluded * Willingness to undergo all study procedures (including the daily consumption of a 1 g gummy during the intervention). * Time and geographic availability to attend the two on-site clinical evaluation sessions at the scheduled times (including a 3-hour session during visit 2). Exclusion Criteria: * Volunteers undergoing pharmacological treatment will be excluded if the treatment has not been stable for at least 3 months prior to study initiation. Excluded treatments include: * Those that alter gastrointestinal function. * Chronic use of stomach protectors. * Any hypoglycemic drugs or insulin. * Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc. * Subjects who have undergone surgical interventions resulting in permanent sequelae in the digestive tract (e.g., gastroduodenostomy) or bariatric surgery. * Subjects with chronic metabolic diseases or obesity-related conditions, or systemic intestinal, hepatic, or renal diseases, including type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (Non-alcoholic fatty liver disease will not be an exclusion criterion). * Exceeding the alcohol consumption limit established for each sex (more than 14 units per week for women and 20 units per week for men). * Pregnant or breastfeeding women, or those planning to become pregnant. * Use of nutritional supplements (such as weight loss supplements, newly initiated fiber supplements, probiotics, postbiotics, etc.) containing compounds that may affect study outcomes, unless the participant agrees to discontinue them during the 12-week intervention period and a minimum 15-day washout period prior to baseline measurements is ensured. * Blood donation within 14 days prior to the baseline visit. * Subjects with any type of cancer or undergoing cancer treatment, or for whom less than 5 years have passed since remission. * Subjects allergic to any component of the study product or to any other food that could interfere with or hinder study compliance. * Subjects presenting any type of cognitive and/or psychiatric impairment. * Subjects anticipated to have poor compliance or who, in the investigator's opinion, may have difficulty adhering to study procedures. * Subjects currently undergoing treatment for weight loss or body composition modification. * Subjects who are taking or have taken antibiotics within 60 days prior to the baseline visit.
Where this trial is running
Pamplona, Navarre
- Center for Nutrition Research — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Principal investigator: Paula Aranaz, PhD — Center for Nutrition Research
- Study coordinator: Paula Aranaz, PhD
- Email: paranaz@unav.es
- Phone: +34948425600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.