Clinical trial NCT02343380: Timing of Caloric Intake, Diet-induced Thermogenesis and Hormonal Pattern
Official title: Is the Timing of Caloric Intake Associated With Variation in Diet-induced Thermogenesis and Hormonal Pattern?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet-induced Thermogenesis
Keywords: diet-induced thermogenesis
glucose
respiratory quotient
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: Twenty healthy volunteers (ten males and ten females) are recruited among students and graduates attending the Department of Medical Sciences of Turin (Italy) to take part to this randomized cross-over trial.

Participants randomly receive first the standard meal at 8:00 am and the week after the standard meal at 8:00 pm or vice versa. Eight-h before the meal (respectively at 12:00 pm or at 12:00 am), the participants receive the same standard meal (without protein supplementation) at their home, and then are asked to spend in bed the following 6 hours. A 24-h urine collection is collected the day before each test in order to determine total urinary nitrogen excretion.

The standard meal consists of: 100g white bread, 100g ham, 50g cheese, 125g yogurt, 200ml fruit juice, plus 25g protein supplement. The participants must consume each meal in 25-30 minutes.

A 30-min basal calorimetric (Deltatrac II) exam is performed. Participants remain in a supine position but awake and motionless on a hospital bed during the whole period, except during the meal, when they can sit to eat. At 8:00 am (or pm), the participants consume the meal, and then rest in a supine position for 90 min. Then, a second 60 min-calorimetric evaluation is done. From the first calorimetric exam (the basal) until the end of the second (post-prandial) blood samples are drawn every 30 min. The same time schedule is adopted in the case of the morning meal (at 8:00 am) and the evening meal (at 8:00 pm).

The random sequence (morning/evening, evening/morning meal) is computer-generated, using blocks of different lengths in random order.

The following are measured: weight, height, waist circumference, and at baseline and every 30-min during the morning and evening tests: glucose, triglyceride, insulin, free-fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin, noradrenalin.

Eligibility criteria: Inclusion Criteria:

* body mass index 19-26 kg/m2
* habitual moderate exercise level

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Before and 180-min from the beginning of the meal
Secondary outcomes:
measure: 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
timeFrame: From the beginning of the meal for 180-min
measure: 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
timeFrame: From the beginning of the meal for 180-min
measure: Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption
timeFrame: Every 30-min from the beginning of the meal for 180-min
measure: Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption
timeFrame: Every 30-min from the beginning of the meal for 180-min
measure: Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption
timeFrame: Every 30-min from the beginning of the meal for 180-min
Other outcomes:
Locations:
Study officials:
affiliation: University of Turin, Italy
name: Simona Bo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.