Effect of the Timing of Chocolate Intake on Body Fat Distribution, Substrate Oxidation, and Microbiota. Randomized, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Total Body Weight
研究概览
简要总结
The purpose of this investigation is to test the hypothesis that in humans, eating a relatively big amount of chocolate at the wrong time (bedtime) may disrupt our circadian system (change the circadian phase), while taking this same amount of chocolate in the morning (wake up condition) may synchronize it. Other related factors may be also affected such as total body weight and body fat, dietary habits (total energy intake and macronutrient distribution), the timing of food intake and of sleep, daily rhythms of TAP, microflora composition and postprandial glycemia.
详细描述
Recent studies suggest that not only "what" the people eat, but also "when" the people eat may have a significant role in obesity treatment and in the regulation of the circadian system. Thus, the hypothesis of this study is eating a relatively big amount of chocolate at the wrong time, bedtime may affect:
- Metabolism: resting energy expenditure, corrected resting energy respiratory quotient (RQ)
- Glucose metabolism
- Total weight loss
- Food intake, total energy intake, and type of food
- Microflora (feces)
- Mood
- Disrupt our circadian system 7a) Changes in Temperature, Actimetry, and Position 7b) Electrocardiogram (ECG) 7c) Melatonin (two points) cortisol rhythm (three points) While having this same amount of chocolate in the morning (wake up condition) may synchronize it.
Other related factors may be also affected such as total body weight and body fat, dietary habits (total energy intake and macronutrient distribution), the timing of food intake and of sleep, daily rhythms of TAP, microflora composition and postprandial glycemia.
19 women (postmenopausal) following the habitual dietary habits of participants (ad libitum) will have 30% of the habitual total daily calories in chocolate of participants (Nestle, "chocolate with milk") during two consecutive weeks each under three conditions: eating chocolate within 1 hour of habitual wake-time, eating chocolate within 1 hours of habitual bedtime, or eating no chocolate. No other chocolate (i.e., none at all in control and in the washout weeks).
The protocol will be a randomized, cross-over design, with a 1-week washout between each condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •Age: between 45 and 65 year of age
- •Caucasian
- •Menopause
排除标准
- •Pre-menopause women
- •Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders
- •Receiving any pharmacologic treatment other than oral contraceptives
- •Bulimia diagnosis, prone to binge eating
- •Pregnancy
研究组 & 干预措施
Morning Chocolate, then Control Chocolate and Evening/Night Chocolate
First condition is eating 100gr chocolate within one hour of habitual waketime. Second condition is eating no milk chocolate or other chocolate. Third condition is eating 100gr of milk chocolate within 1 hours of habitual bedtime.
干预措施: Chocolate 100gr (Behavioral)
Morning Chocolate, then Evening/Night Chocolate and Control Chocolate
First condition is eating 100gr chocolate within one hour of habitual waketime. Second condition is eating 100gr of milk chocolate within 1 hours of habitual bedtime.
Third condition is eating no milk chocolate or other chocolate.
干预措施: Chocolate 100gr (Behavioral)
Evening/Night Chocolate, then Morning Chocolate and Control Chocolate
First condition is eating 100gr of milk chocolate within 1 hours of habitual bedtime.
Second condition is eating 100gr chocolate within one hour of habitual waketime.
Third condition is eating no milk chocolate or other chocolate.
干预措施: Chocolate 100gr (Behavioral)
Evening/Night Chocolate, then Control Chocolate and Morning Chocolate
First condition is eating 100gr of milk chocolate within 1 hours of habitual bedtime.
Second condition is eating no milk chocolate or other chocolate. Third condition is eating 100gr chocolate within one hour of habitual waketime.
干预措施: Chocolate 100gr (Behavioral)
Control Chocolate, then Morning Chocolate and Evening/Night Chocolate
First condition is eating no milk chocolate or other chocolate. Second condition is eating 100gr chocolate within one hour of habitual waketime.
Third condition is eating 100gr of milk chocolate within 1 hours of habitual bedtime.
干预措施: Chocolate 100gr (Behavioral)
Control Chocolate, then Evening/Night Chocolate and Morning Chocolate
First condition is eating no milk chocolate or other chocolate. Second condition is eating 100gr of milk chocolate within 1 hours of habitual bedtime.
Third condition is eating 100gr chocolate within one hour of habitual waketime.
干预措施: Chocolate 100gr (Behavioral)
结局指标
主要结局
Total Body Weight
时间窗: Baseline and after 2 weeks in each condition
The investigators will measure total body weight after each condition (no chocolate, Morning Chocolate, Night Chocolate)
Resting Energy Expenditure (Indirect Calorimetry)
时间窗: Baseline and after 2 weeks in each condition
The investigators will measure by indirect calorimetry the resting energy expenditure after each condition (no chocolate, Morning Chocolate, Night Chocolate) Changes in Resting Energy Expenditure (Indirect Calorimetry) were determined by changes in resting energy expenditure occurred in the participants between baseline and after 2 weeks in each of the three different experimental conditions. Oxygen (O2) consumption (mL/min) and carbon dioxide (CO2) production (mL/min) were measured. The Respiratory Quotient (RQ) was calculated out of O2 consumption (mL/min) and CO2 production (mL/min). Energy expenditure values (kcal/day) were calculated according to the Weir equation: Metabolic rate (kcal per day) = 1440 (3.9 VO2 + 1.1 VCO2)\*
次要结局
- Fragmentation of Wrist Temperature (WT) Daily Rhythm(Baseline and after 2 weeks in each condition)
- Regularity of Wrist Temperature (WT) Daily Rhythm(Baseline and after 2 weeks in each condition)
- Amplitude of Wrist Temperature (WT) Daily Rhythm(Baseline and after 2 weeks in each condition)
- Changes in Microbiota Diversity (Inverse Simpson Index)(Baseline and after 2 weeks in each condition)
- Concentration of Total Short-chain Fatty Acids (SCFAs)(After 2 weeks in each condition)
- Energy Intake(Baseline and after 2 weeks in each condition)
- Macronutrient Composition(Baseline and after 2 weeks in each condition)
研究者
PROF. MARTA GARAULET AZA
Principal Investigator
Universidad de Murcia