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| Name | Class |
|---|---|
| Creaciones Aromáticas Industriales S.A. | OTHER |
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The purpose of this study is to evaluate the satiating effects of different gummies with encapsulated flavour on overweight subjects (BMI ≥25 and <30 kg / m2). Some studies have shown that the contribution of different flavours could reduce food intake. This have made grown the interest of food industry in incorporate these compounds in food and to being able to develop new functional foods into the control of body weight, as well as variables of glucose metabolism and lipid profile, which can contribute to te prevention of cardiovascular diseases.
A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of the encapsulated flavours in different gummies 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 Gummy | Placebo Comparator | Control gummy with free flavour (without encapsulating) |
|
| Gummy Variety 1 | Experimental | Experimental gummy with 50% free/50% encapsulated flavour |
|
| Gummy Variety 2 | Experimental | Experimental gummy with 100% encapsulated flavour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control gummy with free flavour (without encapsulating) | Other | 12 g/day (3 gummies) |
| |
| 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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| Label | URL |
|---|---|
| La Paz University Hospital Research Institute | View source |
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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)
| Experimental gummy with 50% free/50% encapsulated flavour |
| Other |
12 g/day (3 gummies) |
|
| Experimental gummy with 100% encapsulated flavour | Other | 12 g/day (3 gummies) |
|
| 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 | 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 |