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| Name | Class |
|---|---|
| Go Fruselva, S.L. | UNKNOWN |
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The purpose of this study is to evaluate the satiating effects of different functional yogurts enriched with soluble fiber or vegetable protein 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. On the other hand, protein consumption could have a greater satiety potential compared to other macronutrients.
A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different functional enriched yogurts with soluble fiber or vegetable protein in a group of healthy 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 Yogurt | Placebo Comparator | Control yogurt |
|
| Yogurt Variety 1 | Experimental | Experimental Yogurt 1: Dextrin, wheat bran, whole oatmeal |
|
| Yogurt Variety 2 | Experimental | Experimental Yogurt 2: Pea protein, oatmeal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Yogurt | Other | 125 g/day |
| |
| Yogurt 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 | GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C | Day 1, 8, 15 |
| Amount of food consumed in a "food ad libitum" | 120 min After eating the study product |
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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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Double Blind (Participant and Investigator)
| Other |
125 g/day |
|
| Yogurt Variety 2 | Other | 125 g/day |
|
| 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 | Glucose | Day 1, 8, 15 |
| Change from Baseline Lipid Metabolism Parameters | Cholesterol, LDL-C, HDL-C, TG | 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 | Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders) | Day 1, 8, 15 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |