Evaluation of Protein Bars on Weight Management and Osteoarthicular Health

Overweight and Obesity Clinical Trial

— COLARTIC  

Official title:

Evaluación Del Efecto de la Ingesta de Una Barrita Con Alto Contenido de proteína Sobre el Peso y la Salud Osteoarticular

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06248307
• Other study ID #: 2023.178
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Disease
• Joint Diseases
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Barrita experimental
Nutritional advice, as well as administration of protein bars.
• Barrita Placebo
Nutritional advice, as well as administration of placebo bars.

Locations

Country	Name	City	State
Spain	Centro de Investigacion en Nutricion. Universidad de Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Viscofan

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ponderal evolution	Change in body weight between baseline and end of intervention	16 weeks
Primary	Change in fat mass	Body composition . Change in fat mass between baseline and end of intervention	16 weeks
Primary	Change in fat-free mass	Body composition . Change in fat-free mass between baseline and end of intervention	16 weeks
Secondary	Osteoarticular changes	Measure the knee articular range between baseline and end of intervention	16 weeks
Secondary	Plasma P2P and CTX-II levels	Evaluate changes in markers between baseline and end of intervention	16 weeks