Chocolate and Menopause Time

Not Applicable

Completed

• Conditions: Menopause
• Interventions: Behavioral: Evening Chocolate Timing; Behavioral: No Chocolate Timing; Behavioral: Morning Chocolate Timing

• Registration Number: NCT03949803
• Lead Sponsor: Universidad de Murcia

Brief Summary

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

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:

1. Metabolism: resting energy expenditure, corrected resting energy respiratory quotient (RQ)

2. Glucose metabolism

3. Total weight loss

4. Food intake, total energy intake, and type of food

5. Microflora (feces)

6. Mood

7. 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).

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-01-15
• Study Completion: 2017-04-20
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• Healthy women
• Age: between 45 and 65 year of age
• Caucasian
• Menopause

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Evening Chocolate	Evening Chocolate Timing	Test the if Chocolate Timing before bedtime changes the metabolism
No Chocolate (Control)	No Chocolate Timing	Test the if no Chocolate Timing may affect the metabolism
Morning Chocolate	Morning Chocolate Timing	Test the if Chocolate Timing in the morning changes the metabolism

Primary Outcome Measures

Name	Time	Method
Changes in resting energy expenditure (Indirect calorimetry)	baseline and after two 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 total body weight	baseline and after two weeks in each condition	The investigators will measure total body weight after each condition (no chocolate, Morning Chocolate, Night Chocolate)

Secondary Outcome Measures

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