OverweightSACIGOMANCT03621358
Encapsulated Flavour Effects on Satiety
A study testing Experimental gummy with 50% free/50% encapsulated flavour and Experimental gummy with 100% encapsulated flavour in people with Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Experimental gummy with 50% free/50% encapsulated flavour and Experimental gummy with 100% encapsulated flavour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Control gummy with free flavour (without encapsulating), Experimental gummy with 50% free/50% encapsulated flavour, Experimental gummy with 100% encapsulated flavour
- Keywords
- Satiety, Encapsulated flavour, Gummies, Visual Analogue Scale, Cross-over
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control gummy with free flavour (without encapsulating)Other
12 g/day (3 gummies)
Experimental gummy with 50% free/50% encapsulated flavourOther
12 g/day (3 gummies)
Experimental gummy with 100% encapsulated flavourOther
12 g/day (3 gummies)
| Study group | Role | What they receive |
|---|---|---|
| Control Gummy | Placebo comparator | Control gummy with free flavour (without encapsulating) Receives: Other: Control gummy with free flavour (without encapsulating) |
| Gummy Variety 1 | Experimental | Experimental gummy with 50% free/50% encapsulated flavour Receives: Other: Experimental gummy with 50% free/50% encapsulated flavour |
| Gummy Variety 2 | Experimental | Experimental gummy with 100% encapsulated flavour Receives: Other: Experimental gummy with 100% encapsulated flavour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, 8, 15
Secondary outcomes (8)
Change from Baseline Blood Hormonal Satiety Markers
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Measured: Day 1, 8, 15
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Measured: Day 1, 8, 15
Total amount of food consumed in 24h
24h Food Record Method
Measured: Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters
Glucose
Measured: Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters
Cholesterol, LDL-C, HDL-C, TG
Measured: Day 1, 8, 15
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Measured: 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.
Measured: Day 1, 8, 15
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Measured: Day 1, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start13 Apr 2018
- Primary completion27 Apr 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Creaciones Aromáticas Industriales S.A.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, MD, PhD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621358
- Sponsor's protocol ID
- 5003
- Acronym
- SACIGOMA
- Status last verified
- Apr 2018
- First submitted
- 8 May 2018
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Satiating Effect Using Different Gummies With Encapsulated Flavours in a Group of Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT03621358
- Acronym / sponsor ID
- SACIGOMA / 5003
- Conditions
- Overweight
- Keywords
- Satiety, Encapsulated flavour, Gummies, Visual Analogue Scale, Cross-over
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Creaciones Aromáticas Industriales S.A.
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Gummy | Placebo comparator | Other: Control gummy with free flavour (without encapsulating)Control gummy with free flavour (without encapsulating) |
| Gummy Variety 1 | Experimental | Other: Experimental gummy with 50% free/50% encapsulated flavourExperimental gummy with 50% free/50% encapsulated flavour |
| Gummy Variety 2 | Experimental | Other: Experimental gummy with 100% encapsulated flavourExperimental gummy with 100% encapsulated flavour |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control gummy with free flavour (without encapsulating)12 g/day (3 gummies) | Other | Control Gummy |
| Experimental gummy with 50% free/50% encapsulated flavour12 g/day (3 gummies) | Other | Gummy Variety 1 |
| Experimental gummy with 100% encapsulated flavour12 g/day (3 gummies) | Other | Gummy Variety 2 |
Primary outcome
Change from Baseline Satiety Hunger Assessment
Time frame: Day 1, 8, 15
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.
8 secondary outcomes
Change from Baseline Blood Hormonal Satiety Markers
Time frame: Day 1, 8, 15
Amount of food consumed in a "food ad libitum"
Time frame: Day 1, 8, 15
Total amount of food consumed in 24h
Time frame: Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters
Time frame: Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters
Time frame: Day 1, 8, 15
Anthropometric Parameters
Time frame: Day 1, 8, 15
Sensory Perception
Time frame: Day 1, 8, 15
Adverse Effects
Time frame: Day 1, 8, 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- La Paz University Hospital Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, MD, PhD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental gummy with 50% free/50% encapsulated flavour and Experimental gummy with 100% encapsulated flavour in people with Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Satiety Hunger Assessment (time frame: Day 1, 8, 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.