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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
12
12 g/day (3 gummies)
12 g/day (3 gummies)
12 g/day (3 gummies)
La Paz University Hospital
Madrid, Spain
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.
Time frame: Day 1, 8, 15
Change from Baseline Blood Hormonal Satiety Markers
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Time frame: Day 1, 8, 15
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Time frame: Day 1, 8, 15
Total amount of food consumed in 24h
24h Food Record Method
Time frame: Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters
Glucose
Time frame: Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters
Cholesterol, LDL-C, HDL-C, TG
Time frame: Day 1, 8, 15
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Time frame: 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.
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Time frame: Day 1, 8, 15
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time frame: Day 1, 8, 15