Encapsulated Flavour Effects on Satiety
- Conditions
- Overweight
- Interventions
- Other: Control gummy with free flavour (without encapsulating)Other: Experimental gummy with 50% free/50% encapsulated flavourOther: Experimental gummy with 100% encapsulated flavour
- Registration Number
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Gummy Control gummy with free flavour (without encapsulating) Control gummy with free flavour (without encapsulating) Gummy Variety 1 Experimental gummy with 50% free/50% encapsulated flavour Experimental gummy with 50% free/50% encapsulated flavour Gummy Variety 2 Experimental gummy with 100% encapsulated flavour Experimental gummy with 100% encapsulated flavour
- Primary Outcome Measures
Name Time Method Change from Baseline Satiety Hunger Assessment 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline Blood Hormonal Satiety Markers Day 1, 8, 15 GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Amount of food consumed in a "food ad libitum" Day 1, 8, 15 120 min After eating the study product
Total amount of food consumed in 24h Day 1, 8, 15 24h Food Record Method
Change from Baseline Glucose Metabolism Parameters Day 1, 8, 15 Glucose
Change from Baseline Lipid Metabolism Parameters Day 1, 8, 15 Cholesterol, LDL-C, HDL-C, TG
Anthropometric Parameters Day 1, 8, 15 Weight and height will be combined to report BMI in kg/m2
Sensory Perception Day 1, 8, 15 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 Day 1, 8, 15 Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Trial Locations
- Locations (1)
La Paz University Hospital
🇪🇸Madrid, Spain