Overweight and ObesityCOLARTICNCT06248307
Evaluation of Protein Bars on Weight Management and Osteoarthicular Health
A study testing Barrita experimental in people with Overweight and Obesity and Articular Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Articular Disease
- What is being tested?
- Barrita experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Centro de Investigacion en Nutricion. Universidad de Navarra
Pamplona, Navarre, 31008
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Articular Disease
- Being tested
- Barrita experimental, Barrita Placebo
- Keywords
- Nutritional intervention
- Medical subject headings
- Overweight, Obesity, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrita experimentalDietary supplement
Nutritional advice, as well as administration of protein bars.
Barrita PlaceboDietary supplement
Nutritional advice, as well as administration of placebo bars.
| Study group | Role | What they receive |
|---|---|---|
| Barrita experimental | Experimental | Two bars to be consumed before lunch and before dinner Receives: Dietary Supplement: Barrita experimental |
| Barrita placebo | Placebo comparator | Two bars to be consumed before lunch and before dinner Receives: Dietary Supplement: Barrita Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ponderal evolution
Change in body weight between baseline and end of intervention
Measured: 16 weeks
Change in fat mass
Body composition . Change in fat mass between baseline and end of intervention
Measured: 16 weeks
Change in fat-free mass
Body composition . Change in fat-free mass between baseline and end of intervention
Measured: 16 weeks
Secondary outcomes (2)
Osteoarticular changes
Measure the knee articular range between baseline and end of intervention
Measured: 16 weeks
Plasma P2P and CTX-II levels
Evaluate changes in markers between baseline and end of intervention
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start15 Nov 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel groups, double-blind, randomized intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Viscofan
- Responsible party
- Principal investigator, Santiago Navas, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248307
- Sponsor's protocol ID
- COLARTIC
- Acronym
- COLARTIC
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación Del Efecto de la Ingesta de Una Barrita Con Alto Contenido de proteína Sobre el Peso y la Salud Osteoarticular
- ClinicalTrials.gov ID
- NCT06248307
- Acronym / sponsor ID
- COLARTIC / COLARTIC
- Conditions
- Overweight and Obesity, Articular Disease
- Keywords
- Nutritional intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Viscofan
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel groups, double-blind, randomized intervention
| Arm | Type | Receives |
|---|---|---|
| Barrita experimental | Experimental | Dietary Supplement: Barrita experimentalTwo bars to be consumed before lunch and before dinner |
| Barrita placebo | Placebo comparator | Dietary Supplement: Barrita PlaceboTwo bars to be consumed before lunch and before dinner |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barrita experimentalNutritional advice, as well as administration of protein bars. | Dietary supplement | Barrita experimental |
| Barrita PlaceboNutritional advice, as well as administration of placebo bars. | Dietary supplement | Barrita placebo |
Primary outcome
Ponderal evolution
Time frame: 16 weeks
Change in body weight between baseline and end of intervention
Change in fat mass
Time frame: 16 weeks
Body composition . Change in fat mass between baseline and end of intervention
Change in fat-free mass
Time frame: 16 weeks
Body composition . Change in fat-free mass between baseline and end of intervention
2 secondary outcomes
Osteoarticular changes
Time frame: 16 weeks
Plasma P2P and CTX-II levels
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barrita experimental in people with Overweight and Obesity and Articular Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ponderal evolution (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.