Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety 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
- 19
- 试验地点
- 2
- 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 a meat derivative and a satiating compound on overweight subjects (BMI ≥25 and <30 kg / m2).
详细描述
A randomized, parallel, controlled and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of a meat derivate and a satiating compound in a group of healthy overweight subjects.
The investigators included 20 participants between 18 and 65 years (BMI ≥25 and <30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 2 study products during the 3 experimental phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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.
- •Subjects willing to consume all food present in the brunch type meal.
- •Signed informed consent.
排除标准
- •Subjects with BMI ≥30 or <25 kg /m
- •Subjects with a vegetarian diet or with a great fiber consumption (> 30 g/day)
- •Subjects diagnosed with Diabetes Mellitus.
- •Subjects with dyslipidemia on pharmacological treatment.
- •Subjects with hypertension on pharmacological treatment.
- •Subjects with hyper/hypothyroidism.
- •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 gastrointestinal diseases that affect the digestion or absorption of nutrients.
- •Subjects with severe chronic diseases (hepatic, kidney, ...)
- •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.
- •Subjects who consume regularly oral supplements (i.e. omega-3)
- •Pregnant or breastfeeding women.
- •Women with menstrual irregularities (absence of menstrual cycle at least 2 months).
结局指标
主要结局
Change from Baseline Satiety Hunger Assessment
时间窗: 0 min to 240 min
Visual Analogue Scale (VAS). 100 mm 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
- Change from Baseline Glucose Metabolism Parameters(0 min to 240 min)
- Change from Baseline Blood Hormonal Satiety Markers(0 min to 240 min)
- Anthropometric Parameters(24 hours)
- Adverse Effects(24 hours)
- Amount of food consumed in a "food ad libitum"(240 min)
- Total amount of food consumed in 24h(24 hours)