Encapsulated Flavour Effects on Satiety (SACIGOMA)

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Overweight

Treatments: Other: Control gummy with free flavour (without encapsulating); Other: Experimental gummy with 50% free/50% encapsulated flavour; Other: Experimental gummy with 100% encapsulated flavour

Study type: Interventional

Funder types: Other

Identifiers

NCT03621358

5003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

12 participants in 3 patient groups, including a placebo group

Control Gummy

Placebo Comparator group

Description:

Control gummy with free flavour (without encapsulating)

Treatment:

Other: Control gummy with free flavour (without encapsulating)

Gummy Variety 1

Experimental group

Description:

Experimental gummy with 50% free/50% encapsulated flavour

Treatment:

Other: Experimental gummy with 50% free/50% encapsulated flavour

Gummy Variety 2

Experimental group

Description:

Experimental gummy with 100% encapsulated flavour

Treatment:

Other: Experimental gummy with 100% encapsulated flavour