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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02343380
Enrollment
20
Registered
2015-01-22
Start date
2014-05-31
Completion date
2014-12-31
Last updated
2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet-induced Thermogenesis

Keywords

diet-induced thermogenesis, glucose, respiratory quotient

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.

Interventions

OTHERcalorimetric exam after a standard meal

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

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 pmBefore and 180-min from the beginning of the mealIndirect 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.

Secondary

MeasureTime frameDescription
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 pmFrom the beginning of the meal for 180-minGlucose 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.
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 pmFrom the beginning of the meal for 180-minTriglycerides 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.
Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal ConsumptionEvery 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 ConsumptionEvery 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 ConsumptionEvery 30-min from the beginning of the meal for 180-min

Participant flow

Participants by arm

ArmCount
Morning-first, Then Evening
calorimetric exam after a standard meal calorimetric exam after a standard meal: 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
10
Evening-first, Then Morning
calorimetric exam after a standard meal calorimetric exam after a standard meal: 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
10
Total20

Baseline characteristics

CharacteristicMorning-first, Then EveningEvening-first, Then MorningTotal
Age, Continuous27.9 years
STANDARD_DEVIATION 3.3
27.4 years
STANDARD_DEVIATION 3.6
27.6 years
STANDARD_DEVIATION 3.4
fasting Resting Metabolic rate1545.0 Kcal/min
STANDARD_DEVIATION 266.8
1540.0 Kcal/min
STANDARD_DEVIATION 235
1543.5 Kcal/min
STANDARD_DEVIATION 244.7
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
5 Participants5 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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.

Time frame: Before and 180-min from the beginning of the meal

ArmMeasureValue (MEAN)
MorningIntra-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 pm327.5 kcal/min
EveningIntra-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 pm237.0 kcal/min
Secondary

Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption

Time frame: Every 30-min from the beginning of the meal for 180-min

ArmMeasureValue (MEAN)
MorningIntra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption8013.5 ng/l x h
EveningIntra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption9631.3 ng/l x h
Secondary

Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption

Time frame: Every 30-min from the beginning of the meal for 180-min

ArmMeasureGroupValue (MEAN)
MorningIntra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumptionadrenalin4543.5 ng/l x h
MorningIntra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumptionnoradrenalin37504.9 ng/l x h
EveningIntra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumptionadrenalin3020.7 ng/l x h
EveningIntra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumptionnoradrenalin32718.4 ng/l x h
Secondary

Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption

Time frame: Every 30-min from the beginning of the meal for 180-min

Population: These variables were not measured, since data were not collected.

Secondary

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

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

ArmMeasureGroupValue (MEAN)
MorningVariation 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 pmGlucose AUCs15383 ug/ml*h
MorningVariation 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 pmInsulin AUCs6969 ug/ml*h
EveningVariation 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 pmGlucose AUCs17183 ug/ml*h
EveningVariation 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 pmInsulin AUCs8598 ug/ml*h
Secondary

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

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: From the beginning of the meal for 180-min

ArmMeasureGroupValue (MEAN)
MorningVariation 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 pmtriglyceride AUCs11721 mmol/l*h
MorningVariation 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 pmFFA AUCs38.7 mmol/l*h
EveningVariation 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 pmtriglyceride AUCs12363 mmol/l*h
EveningVariation 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 pmFFA AUCs54.7 mmol/l*h

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026