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| Name | Class |
|---|---|
| Friobas Basilio S.L. | UNKNOWN |
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The purpose of this study is to evaluate the satiating effects of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects (BMI ≥25 and <30 kg / m2).
Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk.
A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects.
The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI ≥25 and <30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Canned Tuna | Placebo Comparator | Control Canned Tuna |
|
| Enriched Canned Tuna Variety 1 | Experimental | Enriched Canned Tuna Variety 1: Wakame fiber |
|
| Enriched Canned Tuna Variety 2 | Experimental | Enriched Canned Tuna Variety 2: Polyphenols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Canned Tuna | Other | 210 g/day |
| |
| Enriched Canned Tuna Variety 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Satiety Hunger Assessment | Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below. | Day 1, 8, 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Blood Hormonal Satiety Markers | Concentration of Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C | Day 1, 8, 15 |
| Amount of food consumed in a "food ad libitum" |
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Inclusion Criteria:
Exclusion Criteria:
6 men and 6 women
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez Candela, MD, PhD | La Paz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital | Madrid | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Other |
210 g/day |
|
| Enriched Canned Tuna Variety 2 | Other | 210 g/day |
|
120 min After eating the study product |
| Day 1, 8, 15 |
| Total amount of food consumed in 24h | 24h Food Record Method | Day 1, 8, 15 |
| Change from Baseline Glucose Metabolism Parameters | Concentration of Glucose | Day 1, 8, 15 |
| Change from Baseline Lipid Metabolism Parameters | Concentration of Cholesterol, LDL-C, HDL-C, TAG | Day 1, 8, 15 |
| Anthropometric Parameters | Weight and height will be combined to report BMI in kg/m2 | Day 1, 8, 15 |
| Sensory Perception Test | Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness. | Day 1, 8, 15 |
| Adverse Effects | Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders) | Day 1, 8, 15 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |