NCT03621358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 13, 2022

Status Verified

April 1, 2018

Enrollment Period

14 days

First QC Date

May 8, 2018

Last Update Submit

January 12, 2022

Conditions

Overweight

Keywords

SatietyEncapsulated flavourGummiesVisual Analogue ScaleCross-over

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change from Baseline Blood Hormonal Satiety Markers

    Day 1, 8, 15

  • Amount of food consumed in a "food ad libitum"

    Day 1, 8, 15

  • Total amount of food consumed in 24h

    Day 1, 8, 15

  • Change from Baseline Glucose Metabolism Parameters

    Day 1, 8, 15

  • Change from Baseline Lipid Metabolism Parameters

    Day 1, 8, 15

  • +3 more secondary outcomes

Study Arms (3)

Control Gummy

PLACEBO COMPARATOR

Control gummy with free flavour (without encapsulating)

Other: Control gummy with free flavour (without encapsulating)

Gummy Variety 1

EXPERIMENTAL

Experimental gummy with 50% free/50% encapsulated flavour

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

Gummy Variety 2

EXPERIMENTAL

Experimental gummy with 100% encapsulated flavour

Other: Experimental gummy with 100% encapsulated flavour

Interventions

Control gummy with free flavour (without encapsulating)OTHER

12 g/day (3 gummies)

Control Gummy
Experimental gummy with 50% free/50% encapsulated flavourOTHER

12 g/day (3 gummies)

Gummy Variety 1
Experimental gummy with 100% encapsulated flavourOTHER

12 g/day (3 gummies)

Gummy Variety 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details6 men and 6 women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital

Madrid, Spain

Location

Related Links

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carmen Gómez Candela, MD, PhD

    La Paz University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind (Participant and Investigator)
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

August 8, 2018

Study Start

April 13, 2018

Primary Completion

April 27, 2018

Study Completion

September 30, 2018

Last Updated

January 13, 2022

Record last verified: 2018-04

Locations

ES(1)