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Completed

NCT Number: NCT06248307

Evaluation of Protein Bars on Weight Management and Osteoarthicular Health

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.

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Key information

Conditions

Overweight and Obesity Articular Disease Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Barrita experimental

Dietary Supplement

Nutritional advice, as well as administration of protein bars.

Barrita Placebo

Dietary Supplement

Nutritional advice, as well as administration of placebo bars.

Primary outcomes

  1. Ponderal evolution

    Time frame: 16 weeks

    Change in body weight between baseline and end of intervention

  2. Change in fat mass

    Time frame: 16 weeks

    Body composition . Change in fat mass between baseline and end of intervention

  3. Change in fat-free mass

    Time frame: 16 weeks

    Body composition . Change in fat-free mass between baseline and end of intervention

Secondary outcomes

  1. Osteoarticular changes

    Time frame: 16 weeks

    Measure the knee articular range between baseline and end of intervention

  2. Plasma P2P and CTX-II levels

    Time frame: 16 weeks

    Evaluate changes in markers between baseline and end of intervention

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Viscofan

Registry information

Official study title

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

Acronym: COLARTIC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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