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| Name | Class |
|---|---|
| Creaciones Aromáticas Industriales, S.A. (CARINSA) | UNKNOWN |
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The purpose of this study is to evaluate the satiating effects of a meat derivative and a satiating compound on overweight subjects (BMI ≥25 and <30 kg / m2).
A randomized, parallel, controlled and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of a meat derivate and a satiating compound in a group of healthy overweight subjects.
The investigators included 20 participants between 18 and 65 years (BMI ≥25 and <30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 2 study products during the 3 experimental phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo meat derivative + Placebo satiating compound | Placebo Comparator | 60 g Placebo meat derivative 25 g Placebo satiating compound |
|
| Placebo meat derivative + Satiating compound | Experimental | 60 g Placebo meat derivative 25 g Satiating compound |
|
| Experimental meat derivative + Placebo satiating control | Experimental | 60 g Experimental meat derivative 25 g Placebo satiating compound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo meat derivative + Placebo satiating compound | Other | Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Satiety Hunger Assessment | Visual Analogue Scale (VAS). 100 mm 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. | 0 min to 240 min |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Blood Hormonal Satiety Markers | Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C | 0 min to 240 min |
| Amount of food consumed in a "food ad libitum" |
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Inclusion Criteria:
Exclusion Criteria:
10 men and 10 women
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| Name | Affiliation | Role |
|---|---|---|
| Bricia López Plaza, PhD | La Paz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Health Research IdiPAZ | Madrid | 28046 | 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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| Placebo meat derivative + Satiating compound | Other | Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water |
|
| Experimental meat derivative + Placebo satiating control | Other | Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water |
|
240 min After eating the study product
| 240 min |
| Total amount of food consumed in 24h | 24h Food Record Method | 24 hours |
| Change from Baseline Glucose Metabolism Parameters | Concentration of Glucose | 0 min to 240 min |
| Anthropometric Parameters | Weight and height will be combined to report BMI in kg/m2 | 24 hours |
| Adverse Effects | Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders) | 24 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |