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

NCT03949803 | Completed Results DMC

• 1 other identifier: 2017ES00004
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause

Keywords

Chocolate; Timing; Menopause; Calorimetry

Outcome Measures

Primary Outcomes (2)

• 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) 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)\*

  Baseline and after 2 weeks in each condition

• Total Body Weight

  The investigators will measure total body weight after each condition (no chocolate, Morning Chocolate, Night Chocolate)

  Baseline and after 2 weeks in each condition

Secondary Outcomes (7)

• 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

Study Arms (6)

Morning Chocolate, then Evening/Night Chocolate and Control Chocolate

EXPERIMENTAL

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.

Behavioral: Chocolate 100gr

Morning Chocolate, then Control Chocolate and Evening/Night Chocolate

EXPERIMENTAL

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.

Behavioral: Chocolate 100gr

Evening/Night Chocolate, then Morning Chocolate and Control Chocolate

EXPERIMENTAL

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.

Behavioral: Chocolate 100gr

Evening/Night Chocolate, then Control Chocolate and Morning Chocolate

EXPERIMENTAL

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.

Behavioral: Chocolate 100gr

Control Chocolate, then Morning Chocolate and Evening/Night Chocolate

EXPERIMENTAL

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.

Behavioral: Chocolate 100gr

Control Chocolate, then Evening/Night Chocolate and Morning Chocolate

EXPERIMENTAL

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.

Behavioral: Chocolate 100gr

Interventions

Chocolate 100gr BEHAVIORAL

Evening/Night Chocolate: Eating 100gr of milk chocolate within 1 hours of habitual bedtime Control Chocolate: Eating no milk chocolate or other chocolate Chocolate Morning: Eating chocolate within one hour of habitual waketime.

Control Chocolate, then Evening/Night Chocolate and Morning Chocolate; Control Chocolate, then Morning Chocolate and Evening/Night Chocolate; Evening/Night Chocolate, then Control Chocolate and Morning Chocolate; Evening/Night Chocolate, then Morning Chocolate and Control Chocolate; Morning Chocolate, then Control Chocolate and Evening/Night Chocolate; Morning Chocolate, then Evening/Night Chocolate and Control Chocolate

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Related Publications (1)

• Hernandez-Gonzalez T, Gonzalez-Barrio R, Escobar C, Madrid JA, Periago MJ, Collado MC, Scheer FAJL, Garaulet M. Timing of chocolate intake affects hunger, substrate oxidation, and microbiota: A randomized controlled trial. FASEB J. 2021 Jul;35(7):e21649. doi: 10.1096/fj.202002770RR.

  PMID: 34164846 DERIVED

Results Point of Contact

• Title: Prof. Marta Garaulet Aza
• Organization: Universidad de Murcia

garaulet@um.es

+34868889478

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: May 14, 2019
• Study Start: November 1, 2016
• Primary Completion: January 15, 2017
• Study Completion: April 20, 2017
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-03