Physiologic Effect of Spices Ingestion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Resting energy expenditure
研究概览
简要总结
Human studies have shown that capsaicin, a compound extracted from chilly peppers, can stimulate certain physiologic functions (for example, energy expenditure, thermogenesis, lipid oxidation, heart rate, etc.).
The purpose of this study is to measure the impact of ingesting various spicy molecules on a set of physiologic parameters compared to a placebo. The molecules were selected for their different sensory properties.
The results of this study will allow us to implement an effective method for measuring the impact of ingesting spices on certain body functions (for example, metabolism and autonomic nervous system activity). This study will also allow us to identify the beneficial properties of eating certain spices.
详细描述
Primary objective and outcome:
The main objective of this study is to establish a methodology to evaluate the acute impact of spice ingestion on metabolism and autonomic nervous system activity.
Primary outcomes:
Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).
Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive minutes (measured by indirect calorimetry).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI: 19-25 kg/m2, ≥ 60 kg body weight
- •Moderate spicy food eaters
- •Having signed the informed consent.
排除标准
- •Any gastrointestinal disorder
- •Subject sensitive or not used to eat spicy food
- •Subject with beard or mustache
- •Abnormal thyroid function
- •Intake of medication that could affect body weight and/or energy expenditure
- •Weight loss > 5% in the last 3 months
- •Under antibiotics or regular treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure, lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
- •History of allergy
- •Physical activity level > 300 min of moderate or intense exercise per week
- •Have a alcohol consumption higher than than 1 drink/day
- •Consumption of illicit drugs
- •Subject who cannot be expected to comply with the study procedures, including consuming the test products
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
结局指标
主要结局
Resting energy expenditure
时间窗: change from baseline to 90 minutes following product intake
Calculation of the resting energy expenditure from continuous measurement of oxygen consumption and carbon dioxid production (indirect calorimetry).
Heart rate variability
时间窗: Change from baseline to 90 minutes following product intake
Power spectral analysis of heart rate variability from continuous measurement of very low, low and high frequency range electrocardiographic signals.
次要结局
- Substrat oxidation(Change from baseline to 90 minutes following product intake)
- Facial skin temperature modification(Change from baseline to 90 minutes following product intakeover 90 min)
- Blood pressure(every 15 minutes over 90 minutes of recording following product intake)