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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mazulet@unav.es
• Phone: +34948425600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.