La Paz University Hospital
Madrid, Spain
NCT Number: NCT03621358
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Madrid, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 g/day (3 gummies)
12 g/day (3 gummies)
12 g/day (3 gummies)
Time frame: Day 1, 8, 15
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
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Time frame: Day 1, 8, 15
120 min After eating the study product
Time frame: Day 1, 8, 15
24h Food Record Method
Time frame: Day 1, 8, 15
Glucose
Time frame: Day 1, 8, 15
Cholesterol, LDL-C, HDL-C, TG
Time frame: Day 1, 8, 15
Weight and height will be combined to report BMI in kg/m2
Time frame: Day 1, 8, 15
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.
Time frame: Day 1, 8, 15
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Instituto de Investigación Hospital Universitario La Paz
Other
Pilot Study to Evaluate the Satiating Effect Using Different Gummies With Encapsulated Flavours in a Group of Healthy Overweight Subjects
Acronym: SACIGOMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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