Articular Disease, Overweight and Obesity
Conditions
Keywords
Nutritional intervention
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.
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.
Interventions
DIETARY_SUPPLEMENTBarrita experimental
Nutritional advice, as well as administration of protein bars.
DIETARY_SUPPLEMENTBarrita Placebo
Nutritional advice, as well as administration of placebo bars.
Sponsors
Viscofan
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
2 parallel groups, double-blind, randomized intervention
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ponderal evolution | 16 weeks | Change in body weight between baseline and end of intervention |
| Change in fat mass | 16 weeks | Body composition . Change in fat mass between baseline and end of intervention |
| Change in fat-free mass | 16 weeks | Body composition . Change in fat-free mass between baseline and end of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Osteoarticular changes | 16 weeks | Measure the knee articular range between baseline and end of intervention |
| Plasma P2P and CTX-II levels | 16 weeks | Evaluate changes in markers between baseline and end of intervention |
Countries
Spain
Outcome results
None listed