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NCT06710106: POSTBIOTICS
Effect of a Low-calorie Diet With a Prebiotic Supplement on Health of Overweight-obese Subjects.
NA trial testing Prebiotic + hypocaloric diet in Polyphenols in 156 participants. Completed in 23 May 2025.
23 May 2025
Quick facts
| Lead sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 156 |
| Start date | 13 December 2024 |
| Primary completion | 23 May 2025 |
| Estimated completion | 23 May 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Prebiotic + hypocaloric diet
- Placebo + hypocaloric diet
Conditions studied
- Polyphenols — all drugs for Polyphenols →
- Obesity — all drugs for Obesity →
- Weight Loss — all drugs for Weight Loss →
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Who can join
Adults 18 to 70, any sex, with Polyphenols or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of this project is to evaluate the effect of prebiotic supplementation on weight loss and other physiological and metabolic parameters related to excess weight in overweight/obese adult men and women, as well as to determine the changes in the gut microbiota associated with these changes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters: * Weight and body composition. * Changes in the gut microbiota (metagenomics). * Changes in urinary and serum metabolites. * Complete blood count, routine biochemical variables related to glucose and lipid metabolism, as well as liver health parameters. * Specific markers involved in obesity pathology (insulin, leptin, adiponectin, and cytokines MCP1, TNF, CRP, and IL10). * Satiety-related variables using a visual analog scale. * Adherence to the assigned intervention, both to the hypocaloric diet and to the supplement provided in the study. * Physical activity level. * Changes in gastrointestinal health through self-reported questionnaires. * Mental health and quality of life of participants through self-reported questionnaires. * Chronotype of participants through a self-reported questionnaire. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 156 subjects. Participants will be allocated in two groups for 8 weeks: * Experimental group (n=104): hypocaloric diet + prebiotic supplement. * Placebo group (n=52): hypocaloric diet + placebo supplement. Participants will visit nutritional intervention unit at week 1 and week 8. At week 4 they will receive a phone control call.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06710106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polyphenols
Currently open trials in the same condition.
- NCT06878612 — a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors · Phase 1 · recruiting
Other Clinica Universidad de Navarra, Universidad de Navarra trials
Trials by the same sponsor.
- NCT07370571 — NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE) · not yet recruiting
- NCT07165431 — Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2). · NA · recruiting
- NCT07447440 — Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases · recruiting
- NCT07191210 — Co-Designed Comprehensive Transition Programme for First-Line Nurse Managers · NA · not yet recruiting
- NCT07132060 — MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06710106 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Clinica Universidad de Navarra, Universidad de Navarra
- Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06710106.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing