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Encapsulated Flavour Effects on Satiety (SACIGOMA)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control gummy with free flavour (without encapsulating)
Experimental gummy with 50% free/50% encapsulated flavour
Experimental gummy with 100% encapsulated flavour
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Satiety, Encapsulated flavour, Gummies, Visual Analogue Scale, Cross-over

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • La Paz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control Gummy

Gummy Variety 1

Gummy Variety 2

Arm Description

Control gummy with free flavour (without encapsulating)

Experimental gummy with 50% free/50% encapsulated flavour

Experimental gummy with 100% encapsulated flavour

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2018
Last Updated
January 12, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Creaciones Aromáticas Industriales S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03621358
Brief Title
Encapsulated Flavour Effects on Satiety
Acronym
SACIGOMA
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Creaciones Aromáticas Industriales S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Satiety, Encapsulated flavour, Gummies, Visual Analogue Scale, Cross-over

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind (Participant and Investigator)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Gummy
Arm Type
Placebo Comparator
Arm Description
Control gummy with free flavour (without encapsulating)
Arm Title
Gummy Variety 1
Arm Type
Experimental
Arm Description
Experimental gummy with 50% free/50% encapsulated flavour
Arm Title
Gummy Variety 2
Arm Type
Experimental
Arm Description
Experimental gummy with 100% encapsulated flavour
Intervention Type
Other
Intervention Name(s)
Control gummy with free flavour (without encapsulating)
Intervention Description
12 g/day (3 gummies)
Intervention Type
Other
Intervention Name(s)
Experimental gummy with 50% free/50% encapsulated flavour
Intervention Description
12 g/day (3 gummies)
Intervention Type
Other
Intervention Name(s)
Experimental gummy with 100% encapsulated flavour
Intervention Description
12 g/day (3 gummies)
Primary Outcome Measure Information:
Title
Change from Baseline Satiety Hunger Assessment
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline Blood Hormonal Satiety Markers
Description
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Time Frame
Day 1, 8, 15
Title
Amount of food consumed in a "food ad libitum"
Description
120 min After eating the study product
Time Frame
Day 1, 8, 15
Title
Total amount of food consumed in 24h
Description
24h Food Record Method
Time Frame
Day 1, 8, 15
Title
Change from Baseline Glucose Metabolism Parameters
Description
Glucose
Time Frame
Day 1, 8, 15
Title
Change from Baseline Lipid Metabolism Parameters
Description
Cholesterol, LDL-C, HDL-C, TG
Time Frame
Day 1, 8, 15
Title
Anthropometric Parameters
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
Day 1, 8, 15
Title
Sensory Perception
Description
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
Title
Adverse Effects
Description
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
Day 1, 8, 15

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
6 men and 6 women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, MD, PhD
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.idipaz.es
Description
La Paz University Hospital Research Institute

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Encapsulated Flavour Effects on Satiety

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