Pilot Study to Evaluate the Satiating Effect Using Different Gummies With Encapsulated Flavours in a Group of Healthy Overweight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from Baseline Satiety Hunger Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind (Participant and Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 18 to 65 years old.
- •Body Mass Index (BMI) ≥25 and <30 kg/m
- •Adequate cultural level and understanding for the clinical trial.
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
Control Gummy
Control gummy with free flavour (without encapsulating)
干预措施: Control gummy with free flavour (without encapsulating) (Other)
Gummy Variety 1
Experimental gummy with 50% free/50% encapsulated flavour
干预措施: Experimental gummy with 50% free/50% encapsulated flavour (Other)
Gummy Variety 2
Experimental gummy with 100% encapsulated flavour
干预措施: Experimental gummy with 100% encapsulated flavour (Other)
结局指标
主要结局
Change from Baseline Satiety Hunger Assessment
时间窗: 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.
次要结局
- Anthropometric Parameters(Day 1, 8, 15)
- Change from Baseline Glucose Metabolism Parameters(Day 1, 8, 15)
- Change from Baseline Lipid Metabolism Parameters(Day 1, 8, 15)
- 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)
- Sensory Perception(Day 1, 8, 15)
- Adverse Effects(Day 1, 8, 15)