Chocolate and Menopause Time

Study Overview
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Brief Summary
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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.

Detailed Description
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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. During the 14 days in each condition, the participants will record sleep and activity schedules by dairy, food intake and food timing by phone application, daily rhythms of wrist temperature, activity and position (TAP).

Official Title
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Eating Chocolate at the Right Time Benefits the Circadiam Sytem and Metabolic Efficiency.

Conditions
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Menopause

Intervention / Treatment
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* Behavioral: Morning Chocolate Timing
* Behavioral: Evening Chocolate Timing
* Behavioral: No Chocolate Timing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women Age: between 45 and 65 year of age Caucasian Menopause Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morning Chocolate<br>Test the if Chocolate Timing in the morning changes the metabolism | Behavioral: Morning Chocolate Timing<br>* During two consecutive weeks volunteers will eat chocolate within 1 hour of their habitual wake-time (100g).<br>|
| Experimental: Evening Chocolate<br>Test the if Chocolate Timing before bedtime changes the metabolism | Behavioral: Evening Chocolate Timing<br>* During two consecutive weeks volunteers will eat chocolate within 1 hours of habitual bedtime (100g).<br>|
| Experimental: No Chocolate (Control)<br>Test the if no Chocolate Timing may affect the metabolism | Behavioral: No Chocolate Timing<br>* During two consecutive weeks volunteers will not eat chocolate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in resting energy expenditure (Indirect calorimetry) | The investigators will measure by indirect calorimetry the resting energy expenditure after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 
| Changes in total body weight | The investigators will measure total body weight after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in daily rhythm of wrist temperature fragmentation | The investigators will measure the fragmentation parameter derived from wrist temperature after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 
| Changes in daily rhythm of wrist temperature regularity | The investigators will measure the regularity parameter derived from wrist temperature after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 
| Changes in daily rhythm of wrist temperature amplitude | The investigators will measure the amplitude parameter derived from wrist temperature after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 
| Changes in microbiota diversity | The investigators will measure microbiota diversity changes | baseline and after two weeks in each condition | 
| Changes in microbiota abundance | The investigators will measure microbiota abundance changes | baseline and after two weeks in each condition | 
| Energy intake | The investigators will measure changes in total energy intake after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 
| Macronutrient composition | The investigators will measure changes in macronutrient composition after each condition (no chocolate, Morning Chocolate, Night Chocolate) | baseline and after two weeks in each condition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chocolate, Timing, Menopause, Calorimetry