Evaluation of Protein Bars on Weight Management and Osteoarthicular Health

Not Applicable

Completed

• Conditions: Articular Disease; Overweight and Obesity
• Interventions: Dietary Supplement: Barrita experimental; Dietary Supplement: Barrita Placebo

• Registration Number: NCT06248307
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

The goal of this intervention study is to evaluate the efficacy in subjects with overweight or obesity of protein bars consumption. The main questions it aims to answer are:

* Does the regular consumption of these protein bars help to loose weight?

* Does the regular consumption of these protein bars help to improve the osteoarticular health? Participants will be asked to follow the indications of consumption of the bars togather with healthy nutritional advice during 16 weeks.

Researchers will compare exparimental Versus placebo groups to see if weight is lost in similar or different ways.

Detailed Description

The intervention is designed to evaluate the efficacy of the consumption of a protein bar vs placebo on weight control and osteoarticular health.

For this purpose, a total of 102 subjects will be randomised to either the experimental group or the placebo group, the only stratification performed will be acording to sex.

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-08
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• BMI between 25 and 37.5 kg/m2
• Normal physical examination and vital signs according to clinical examiners.
• Chronic pharmacological treatment is permitted if dosage is stable within at least three months prior the start of the intervention.

Exclusion Criteria

• Any funcitonal or structural impairment in digestive system (hitus hernia, ulcers, inflammatory bowel disease, etc.)
• Excessive alcohol consumption (> 14 units/week in women and > 20 units per week in men)
• Bariatric surgery or similar
• Arthritis, hepatic diseases, cancer.
• Alergy to any component of the products
• Subjects presenting any cognitive or psichiatric impairment, that may impel them to follow the protocol.
• Subjects following any weight loss program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barrita experimental	Barrita experimental	Two bars to be consumed before lunch and before dinner
Barrita placebo	Barrita Placebo	Two bars to be consumed before lunch and before dinner

Primary Outcome Measures

Name	Time	Method
Change in fat mass	16 weeks	Body composition . Change in fat mass between baseline and end of intervention
Ponderal evolution	16 weeks	Change in body weight between baseline and end of intervention
Change in fat-free mass	16 weeks	Body composition . Change in fat-free mass between baseline and end of intervention

Secondary Outcome Measures

Name	Time	Method
Osteoarticular changes	16 weeks	Measure the knee articular range between baseline and end of intervention
Plasma P2P and CTX-II levels	16 weeks	Evaluate changes in markers between baseline and end of intervention

Trial Locations

Locations (1)

Centro de Investigacion en Nutricion. Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain