Eating Chocolate at the Right Time Benefits the Circadiam Sytem and Metabolic Efficiency. (ONTIME-CHOC)

Universidad de Murcia

Status: Completed

Conditions: Menopause

Treatments: Behavioral: Chocolate 100gr

Study type: Interventional

Funder types: Other

Identifiers

NCT03949803

2017ES00004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 19 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 6 patient groups

Morning Chocolate, then Evening/Night Chocolate and Control Chocolate

Experimental group

Description:

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.

Treatment:

Behavioral: Chocolate 100gr

Morning Chocolate, then Control Chocolate and Evening/Night Chocolate

Experimental group

Description:

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.

Treatment:

Behavioral: Chocolate 100gr

Evening/Night Chocolate, then Morning Chocolate and Control Chocolate

Experimental group

Description:

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.

Treatment:

Behavioral: Chocolate 100gr

Evening/Night Chocolate, then Control Chocolate and Morning Chocolate

Experimental group

Description:

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.

Treatment:

Behavioral: Chocolate 100gr

Control Chocolate, then Morning Chocolate and Evening/Night Chocolate

Experimental group

Description:

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.

Treatment:

Behavioral: Chocolate 100gr

Control Chocolate, then Evening/Night Chocolate and Morning Chocolate

Experimental group

Description:

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.

Treatment:

Behavioral: Chocolate 100gr