NCT Number: NCT02343380
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.
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Notify Me20 year–35 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Before and 180-min from the beginning of the meal
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.
Time frame: From the beginning of the meal for 180-min
Glucose and insulin values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.
Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay.
Time frame: From the beginning of the meal for 180-min
Triglycerides and FFA values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.
FFA concentrations were measured by a fluorometric assay. Plasma triglycerides were assayed by enzymatic colorimetric method.
Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay.
Time frame: Every 30-min from the beginning of the meal for 180-min
Time frame: Every 30-min from the beginning of the meal for 180-min
Time frame: Every 30-min from the beginning of the meal for 180-min
University of Turin, Italy
Other
Is the Timing of Caloric Intake Associated With Variation in Diet-induced Thermogenesis and Hormonal Pattern?
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