Evaluation of Protein Bars on Weight Management and Osteoarthicular Health

NCT ID: NCT06248307

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-07-30

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.

Conditions

Overweight and Obesity; Articular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Barrita experimental

Two bars to be consumed before lunch and before dinner

Group Type: EXPERIMENTAL

Barrita experimental

Intervention Type: DIETARY_SUPPLEMENT

Nutritional advice, as well as administration of protein bars.

Barrita placebo

Two bars to be consumed before lunch and before dinner

Group Type: PLACEBO_COMPARATOR

Barrita Placebo

Intervention Type: DIETARY_SUPPLEMENT

Nutritional advice, as well as administration of placebo bars.

Interventions

Barrita experimental

Nutritional advice, as well as administration of protein bars.

Intervention Type: DIETARY_SUPPLEMENT

Barrita Placebo

Nutritional advice, as well as administration of placebo bars.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Viscofan

INDUSTRY

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Santiago Navas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

COLARTIC

Identifier Type: -

Identifier Source: org_study_id