Chocolate and Menopause Time

Menopause Clinical Trial

— ONTIME-CHOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949803
• Other study ID #: 2017ES00004
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: April 20, 2017

Study information

• Verified date: April 2021
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 20, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Behavioral:
• Morning Chocolate Timing
During two consecutive weeks volunteers will eat chocolate within 1 hour of their habitual wake-time (100g).
• Evening Chocolate Timing
During two consecutive weeks volunteers will eat chocolate within 1 hours of habitual bedtime (100g).
• No Chocolate Timing
During two consecutive weeks volunteers will not eat chocolate.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Changes in microbiota diversity	The investigators will measure microbiota diversity changes	baseline and after two weeks in each condition
Secondary	Changes in microbiota abundance	The investigators will measure microbiota abundance changes	baseline and after two weeks in each condition
Secondary	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
Secondary	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