Evaluation of Protein Bars on Weight Management and Osteoarthicular Health (COLARTIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Articular Disease; Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Barrita experimental; Dietary supplement: Barrita Placebo

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Centro de Investigacion en Nutricion. Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barrita experimental; Two bars to be consumed before lunch and before dinner	Dietary supplement: Barrita experimental; Nutritional advice, as well as administration of protein bars.
Placebo Comparator: Barrita placebo; Two bars to be consumed before lunch and before dinner	Dietary supplement: Barrita Placebo; Nutritional advice, as well as administration of placebo bars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ponderal evolution	Change in body weight between baseline and end of intervention	16 weeks
Change in fat mass	Body composition . Change in fat mass between baseline and end of intervention	16 weeks
Change in fat-free mass	Body composition . Change in fat-free mass between baseline and end of intervention	16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Viscofan

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Nutritional intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Musculoskeletal Diseases; Joint Diseases; Overweight
• Other Study ID Numbers: COLARTIC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No