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| Name | Class |
|---|---|
| Viscofan | INDUSTRY |
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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:
Researchers will compare exparimental Versus placebo groups to see if weight is lost in similar or different ways.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barrita experimental | Experimental | Two bars to be consumed before lunch and before dinner |
|
| Barrita placebo | Placebo Comparator | Two bars to be consumed before lunch and before dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barrita experimental | Dietary Supplement | Nutritional advice, as well as administration of protein bars. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Osteoarticular changes | Measure the knee articular range between baseline and end of intervention | 16 weeks |
| Plasma P2P and CTX-II levels | Evaluate changes in markers between baseline and end of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigacion en Nutricion. Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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2 parallel groups, double-blind, randomized intervention
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| Barrita Placebo | Dietary Supplement | Nutritional advice, as well as administration of placebo bars. |
|
| 16 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009140 | Musculoskeletal Diseases |