Clinical trial NCT03949803: Eating Chocolate at the Right Time Benefits the Circadiam Sytem and Metabolic Efficiency.
Official title: Effect of the Timing of Chocolate Intake on Body Fat Distribution, Substrate Oxidation, and Microbiota. Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Chocolate
Timing
Menopause
Calorimetry
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 19
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Resting Energy Expenditure (Indirect Calorimetry)
timeFrame: Baseline and after 2 weeks in each condition
measure: Total Body Weight
timeFrame: Baseline and after 2 weeks in each condition
Secondary outcomes:
measure: Fragmentation of Wrist Temperature (WT) Daily Rhythm
timeFrame: Baseline and after 2 weeks in each condition
measure: Regularity of Wrist Temperature (WT) Daily Rhythm
timeFrame: Baseline and after 2 weeks in each condition
measure: Amplitude of Wrist Temperature (WT) Daily Rhythm
timeFrame: Baseline and after 2 weeks in each condition
measure: Changes in Microbiota Diversity (Inverse Simpson Index)
timeFrame: Baseline and after 2 weeks in each condition
measure: Concentration of Total Short-chain Fatty Acids (SCFAs)
timeFrame: After 2 weeks in each condition
measure: Energy Intake
timeFrame: Baseline and after 2 weeks in each condition
measure: Macronutrient Composition
timeFrame: Baseline and after 2 weeks in each condition
Other outcomes:
Locations:
Study officials:
References:
citation: 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.