Clinical trial NCT03621358: Encapsulated Flavour Effects on Satiety
Official title: Pilot Study to Evaluate the Satiating Effect Using Different Gummies With Encapsulated Flavours in a Group of Healthy Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Satiety
Encapsulated flavour
Gummies
Visual Analogue Scale
Cross-over
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Creaciones Aromáticas Industriales S.A.
First posted: 2018-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent

Exclusion Criteria:

* Subjects with BMI ≥30 or \<25 kg /m2
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer)
* Subjects under pharmacological treatment (except oral contraceptives)
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance

Primary outcomes:
measure: Change from Baseline Satiety Hunger Assessment
timeFrame: Day 1, 8, 15
Secondary outcomes:
measure: Change from Baseline Blood Hormonal Satiety Markers
timeFrame: Day 1, 8, 15
measure: Amount of food consumed in a "food ad libitum"
timeFrame: Day 1, 8, 15
measure: Total amount of food consumed in 24h
timeFrame: Day 1, 8, 15
measure: Change from Baseline Glucose Metabolism Parameters
timeFrame: Day 1, 8, 15
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Day 1, 8, 15
measure: Anthropometric Parameters
timeFrame: Day 1, 8, 15
measure: Sensory Perception
timeFrame: Day 1, 8, 15
measure: Adverse Effects
timeFrame: Day 1, 8, 15
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: La Paz University Hospital
name: Carmen Gómez Candela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: