Encapsulated Flavour Effects on Satiety (SACIGOMA)

Pilot Study to Evaluate the Satiating Effect Using Different Gummies With Encapsulated Flavours in a Group of Healthy Overweight Subjects

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Other: Control gummy with free flavour (without encapsulating); Other: Experimental gummy with 50% free/50% encapsulated flavour; Other: Experimental gummy with 100% encapsulated flavour

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control Gummy; Control gummy with free flavour (without encapsulating)	Other: Control gummy with free flavour (without encapsulating); 12 g/day (3 gummies)
EXPERIMENTAL: Gummy Variety 1; Experimental gummy with 50% free/50% encapsulated flavour	Other: Experimental gummy with 50% free/50% encapsulated flavour; 12 g/day (3 gummies)
EXPERIMENTAL: Gummy Variety 2; Experimental gummy with 100% encapsulated flavour	Other: Experimental gummy with 100% encapsulated flavour; 12 g/day (3 gummies)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1, 8, 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of food consumed in a "food ad libitum"	120 min After eating the study product	Day 1, 8, 15
Total amount of food consumed in 24h	24h Food Record Method	Day 1, 8, 15
Anthropometric Parameters	Weight and height will be combined to report BMI in kg/m2	Day 1, 8, 15
Change from Baseline Blood Hormonal Satiety Markers	GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C	Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters	Glucose	Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters	Cholesterol, LDL-C, HDL-C, TG	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.	Day 1, 8, 15
Adverse Effects	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)	Day 1, 8, 15

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Creaciones Aromáticas Industriales S.A.

Publications and helpful links

Helpful Links

• La Paz University Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2018
• Primary Completion (ACTUAL): April 27, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Satiety; Visual Analogue Scale; Cross-over; Gummies; Encapsulated flavour
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 5003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No