Evaluation of Protein Bars on Weight Management and Osteoarthicular Health

NCT06248307 | Completed

• 1 other identifier: COLARTIC
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Articular Disease

Keywords

Nutritional intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Osteoarticular changes

  16 weeks

• Plasma P2P and CTX-II levels

  16 weeks

Study Arms (2)

Barrita experimental

EXPERIMENTAL

Two bars to be consumed before lunch and before dinner

Dietary Supplement: Barrita experimental

Barrita placebo

PLACEBO COMPARATOR

Two bars to be consumed before lunch and before dinner

Dietary Supplement: Barrita Placebo

Interventions

Barrita experimental DIETARY_SUPPLEMENT

Nutritional advice, as well as administration of protein bars.

Barrita experimental

Barrita Placebo DIETARY_SUPPLEMENT

Nutritional advice, as well as administration of placebo bars.

Barrita placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Viscofan: collaborator

Study Sites (1)

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity; Joint Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 parallel groups, double-blind, randomized intervention

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 8, 2024
• Study Start: November 15, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

ES (1)