Trial Outcomes & Findings for Timing of Caloric Intake, Diet-induced Thermogenesis and Hormonal Pattern (NCT NCT02343380)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Before and 180-min from the beginning of the meal

Results posted on

2018-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Timing of Caloric Intake, Diet-induced Thermogenesis and Hormonal Pattern

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morning-first, Then Evening n=10 Participants 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	Evening-first, Then Morning n=10 Participants 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	Total n=20 Participants Total of all reporting groups
Age, Continuous	27.9 years STANDARD_DEVIATION 3.3 • n=5 Participants	27.4 years STANDARD_DEVIATION 3.6 • n=7 Participants	27.6 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
fasting Resting Metabolic rate	1545.0 Kcal/min STANDARD_DEVIATION 266.8 • n=5 Participants	1540.0 Kcal/min STANDARD_DEVIATION 235.0 • n=7 Participants	1543.5 Kcal/min STANDARD_DEVIATION 244.7 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Morning n=20 Participants 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	Evening n=20 Participants 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
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	327.5 kcal/min Interval 279.0 to 376.0	237.0 kcal/min Interval 195.1 to 278.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Morning n=20 Participants 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	Evening n=20 Participants 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
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 AUCs	15383 ug/ml*h Interval 14426.0 to 16340.0	17183 ug/ml*h Interval 16111.0 to 18255.0
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 Insulin AUCs	6969 ug/ml*h Interval 5664.0 to 8274.0	8598 ug/ml*h Interval 6618.0 to 10578.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Morning n=20 Participants 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	Evening n=20 Participants 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
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 FFA AUCs	38.7 mmol/l*h Interval 30.9 to 46.5	54.7 mmol/l*h Interval 40.6 to 68.9
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 triglyceride AUCs	11721 mmol/l*h Interval 9794.0 to 13648.0	12363 mmol/l*h Interval 11068.0 to 13658.0

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Morning n=20 Participants 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	Evening n=20 Participants 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
Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption adrenalin	4543.5 ng/l x h Interval 3204.6 to 5882.4	3020.7 ng/l x h Interval 2618.4 to 3423.0
Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption noradrenalin	37504.9 ng/l x h Interval 32516.8 to 42492.9	32718.4 ng/l x h Interval 25987.6 to 39449.3

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Morning n=20 Participants 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	Evening n=20 Participants 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
Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption	8013.5 ng/l x h Interval 6190.4 to 9836.7	9631.3 ng/l x h Interval 7296.0 to 11966.6

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

Adverse Events

Morning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Evening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Simona Bo

University of Turin

Phone: 0039116335543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place