Satiating protein or fiber bars with a reduced-calorie diet for weight, joint, and cardiometabolic health

Evaluation of the Effect of Supplementation With Satiating Compounds Integrated Into a Hypocaloric Diet on Weight and Cardiometabolic and Osteoarticular Health in Overweight/Obese Subjects

We will test whether eating three satiating protein or fiber bars per day along with a modest reduced-calorie diet helps adults with overweight or obesity lose weight and improve joint and cardiometabolic health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra (other)
• Locations: 1 site (Pamplona, Navarre)
• Trial ID: NCT07165548 on ClinicalTrials.gov

What this trial studies

Adults with overweight or obesity will be randomly assigned to one of four groups (three different experimental bar formulations or a placebo bar), and all groups will follow a 10% hypocaloric diet while consuming three bars per day for 12 weeks. Participants attend visits at baseline, week 8, and week 12, where weight, body composition, blood pressure, and knee range of motion are measured. Blood, urine, and stool samples are collected and validated questionnaires capture dietary intake, physical activity, sleep, and gastrointestinal symptoms. The trial compares weight, body composition, osteoarticular measures, and cardiometabolic biomarkers across groups to see if the bars add benefit to modest calorie reduction.

Who should consider this trial

Good fit: Adults aged 18–65 years with BMI 27.0–39.9 kg/m2, stable weight for the prior three months, able to follow a modest hypocaloric diet and take three bars daily, and not treated for diabetes are the intended participants.

Not a fit: People with diabetes, significant functional or structural digestive disorders, unstable medical conditions, BMI outside 27.0–39.9 kg/m2, or inability to attend the Pamplona visits are unlikely to be eligible or benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could provide a simple, food-based way to boost weight loss and improve metabolic and joint-related measures for people with overweight or obesity.

How similar studies have performed: Previous trials of higher-protein or higher-fiber snacks have produced modest improvements in satiety and weight control, but combined effects on joint health and cardiometabolic biomarkers remain less well studied.

Eligibility criteria

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 or structural abnormalities of the digestive system, including but not limited to congenital malformations, angiodysplasia, active peptic ulcer disease, chronic inflammatory or malabsorption disorders, hiatal hernia, or chronic gastroesophageal reflux.
* High alcohol consumption, defined as \>14 units per week for women and \>20 units per week for men.
* Pregnancy or lactation at the time of screening.
* History of surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or joint replacement surgery (hip or knee).
* Diagnosis of arthritis.
* History of any liver disease, with the exception of non-alcoholic fatty liver disease.
* Diagnosis of any type of cancer, current cancer treatment, or history of cancer treatment within the past five years.
* Known allergy or hypersensitivity to any component of the investigational product or to any food that could interfere with study participation and follow-up.
* Presence of cognitive and/or psychological impairment that could affect study compliance.
* Anticipated poor adherence or, in the opinion of the investigator, inability to comply with study procedures.
* Engagement in night-shift work.
* Current use of dietary supplements that may interfere with study outcomes (e.g., nutraceuticals containing compounds with potential weight loss effects).
* Ongoing treatment for weight loss or diabetes.

Where this trial is running

Pamplona, Navarre

• Center for Nutrition Research — Pamplona, Navarre, Spain (RECRUITING)

Study contacts

• Principal investigator: María Ángeles Zulet, PhD — Center for Nutrition Research
• Study coordinator: María Ángeles Zulet, PhD

Conditions: Obesity, Overweight, Nutritional intervention, Dietary supplement, Protein bar, Fiber bar, Hypocaloric Diet, Weight loss