Timing of Caloric Intake, Diet-induced Thermogenesis and Hormonal Pattern
Is the Timing of Caloric Intake Associated With Variation in Diet-induced Thermogenesis and Hormonal Pattern?
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The investigators aim at analyzing whether eating a standard meal in the evening (at 8:00 pm) determines in the same individuals a lower diet-induced thermogenesis (DIT) and a different hormonal response than the consumption of the same meal in the morning (at 8:00 am). The primary outcome is: the intra-individual variation in DIT after the evening and morning meal consumption. The secondary outcomes are the intra-individual variations in glucose, triglyceride, insulin, free fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin, noradrenalin, after the evening and morning meal consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedResults Posted
Study results publicly available
December 31, 2015
CompletedJanuary 24, 2018
January 1, 2018
2 months
January 12, 2015
August 20, 2015
January 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intra-individual Variation in Morning Diet-induced Thermogenesis (DIT) Evaluated by Calorimetric Exam After the Consumption of a Meal at 8:00 am Compared With Evening DIT Evaluated by Calorimetric Exam After the Consumption of the Same Meal at 8:00 pm
Indirect calorimetry by Deltatrac II (DATEX, Division of Instruments Corp. Helsinki, Finland) is used to measure the rate of energy expenditure before- and after- the meal.Diet-induced thermogenesis is considered as the difference between average after-meal and basal energy expenditure.
Before and 180-min from the beginning of the meal
Secondary Outcomes (5)
Variation in Morning Glucose and Insulin Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm
From the beginning of the meal for 180-min
Variation in Morning Triglyceride and Free Fatty Acid (FFA) Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm
From the beginning of the meal for 180-min
Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption
Every 30-min from the beginning of the meal for 180-min
Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption
Every 30-min from the beginning of the meal for 180-min
Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption
Every 30-min from the beginning of the meal for 180-min
Study Arms (2)
morning-first
EXPERIMENTALcalorimetric exam after a standard meal
evening-first
EXPERIMENTALcalorimetric exam after a standard meal
Interventions
The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting
Eligibility Criteria
You may qualify if:
- body mass index 19-26 kg/m2
- habitual moderate exercise level
You may not qualify if:
- any acute or chronic diseases
- menopause
- any drugs or supplementations
- any alimentary restrictions or specific diets
- being a shift or night workers
- unable to give a written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Bo S, Fadda M, Castiglione A, Ciccone G, De Francesco A, Fedele D, Guggino A, Parasiliti Caprino M, Ferrara S, Vezio Boggio M, Mengozzi G, Ghigo E, Maccario M, Broglio F. Is the timing of caloric intake associated with variation in diet-induced thermogenesis and in the metabolic pattern? A randomized cross-over study. Int J Obes (Lond). 2015 Dec;39(12):1689-95. doi: 10.1038/ijo.2015.138. Epub 2015 Jul 29.
PMID: 26219416DERIVED
Results Point of Contact
- Title
- Dr Simona Bo
- Organization
- University of Turin
Study Officials
- PRINCIPAL INVESTIGATOR
Simona Bo, MD
University of Turin, Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
- Professor Assistant, MD
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 22, 2015
Study Start
May 1, 2014
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
January 24, 2018
Results First Posted
December 31, 2015
Record last verified: 2018-01