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

University of Navarra

Status: Completed

Conditions: Articular Disease; Overweight and Obesity

Treatments: Dietary Supplement: Barrita Placebo; Dietary Supplement: Barrita experimental

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06248307

COLARTIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

Barrita experimental

Experimental group

Description:

Two bars to be consumed before lunch and before dinner

Treatment:

Dietary Supplement: Barrita experimental

Barrita placebo

Placebo Comparator group

Description:

Two bars to be consumed before lunch and before dinner

Treatment:

Dietary Supplement: Barrita Placebo