Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoart
The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity. To achieve this objective, volunteers will be instructed to co
| Condition(s) | Obesity, Overweight |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity. To achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period. The main questions to answer are: * Does the regular consumption of these protein and/or fiber bars help to lose weight? * Does the regular consumption of these protein and/or fiber bars help to improve the osteoarticular health? * Does the regular consumption of these protein and/or fiber bars help to improve the cardiometabolic health? The specif |
| Who can participate | Inclusion Criteria: * Volunteers of both sexes between the ages of 18 and 65 years old. * Volunteers with grade II overweight or obesity (BMI: 27.0-39.9 kg/m2). * Physical examination and vital signs are normal or clinically irrelevant to the study. * Volunteers receiving pharmacological treatment may be included if the dosage has remained stable for at least three months prior to study initiation. * Individuals undergoing treatment for diabetes will be excluded. * Participants must be capable of understanding the study requirements, willing to provide written informed consent, and able to comply with all study procedures and timelines. * Body weight must have remained stable (±5%) during the three months preceding study initiation. Exclusion Criteria: * Presence of significant functional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
| Locations | Pamplona, Navarre, Spain |
| Start date | 2025-08-20 |
| NCT ID | NCT07165548 |
| Official listing | https://clinicaltrials.gov/study/NCT07165548 |