Encapsulated Flavour Effects on Satiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2018-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Double Blind (Participant and Investigator)

Study Groups

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Control Gummy

Control gummy with free flavour (without encapsulating)

Group Type PLACEBO_COMPARATOR

Control gummy with free flavour (without encapsulating)

Intervention Type OTHER

12 g/day (3 gummies)

Gummy Variety 1

Experimental gummy with 50% free/50% encapsulated flavour

Group Type EXPERIMENTAL

Experimental gummy with 50% free/50% encapsulated flavour

Intervention Type OTHER

12 g/day (3 gummies)

Gummy Variety 2

Experimental gummy with 100% encapsulated flavour

Group Type EXPERIMENTAL

Experimental gummy with 100% encapsulated flavour

Intervention Type OTHER

12 g/day (3 gummies)

Interventions

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Control gummy with free flavour (without encapsulating)

12 g/day (3 gummies)

Intervention Type OTHER

Experimental gummy with 50% free/50% encapsulated flavour

12 g/day (3 gummies)

Intervention Type OTHER

Experimental gummy with 100% encapsulated flavour

12 g/day (3 gummies)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes