Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

Study Overview
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Brief Summary
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Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute interval between them, after an 10-h overnight fast in a temperature controlled room. The subjects will be randomized in two groups: one will receive a sensorial stimulus during the interval (stimulus group - SG) and the other will receive no stimulus (control group - CG). The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste. Baseline microvascular parameters will be compared to the results after the interval. The investigators hypothesize that the SG will have greater capillary recruitment due to a possible effect of physiologically secreted insulin provoked by the sensorial stimulation (cephalic phase of insulin secretion).

Official Title
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Relations Among Cephalic Phase of Insulin Secretion, Body Composition, Dietary Intake and Microvascular Reactivity in Healthy Young Men

Conditions
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Microvascular Function

Intervention / Treatment
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* Other: Breakfast tray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers Aged between 18 and 30 years BMI between 18.5 and 24.9 kg/m2 Exclusion Criteria: Diabetes mellitus, glucose intolerance or altered fasting glucose; Hypertension (Systolic pressure ≥ 130 mmHg and diastolic pressure ≥ 80 mmHg); HOMA-index ≥ 2.71 Dyslipidemia Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases Smoking Chronic use of any medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Sensorial Stimulus<br>The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste, in order to trigger the cephalic phase of insulin secretion | Other: Breakfast tray<br>* The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capillary density (number of perfused capillaries on the studied skin area) |  | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cephalic phase of insulin secretion (the occurence of increase in markers of this phase, such as insulin, C-peptide and pancreatic polypeptide) |  | Up to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capillary recruitment, Cephalic Phase of Insulin Secretion, Dietary Intake