Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

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

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).

Study Overview

• Status: Completed
• Conditions: Microvascular Function
• Intervention / Treatment: Other: Breakfast tray

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20550-013
    • Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Sensorial Stimulus; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Caroline Buss, Master, Rio de Janeiro State University

Publications and helpful links

General Publications

• Buss C, Kraemer-Aguiar LG, Maranhao PA, Marinho C, de Souza Md, Wiernsperger N, Bouskela E. Novel findings in the cephalic phase of digestion: a role for microcirculation? Physiol Behav. 2012 Feb 28;105(4):1082-7. doi: 10.1016/j.physbeh.2011.12.004. Epub 2011 Dec 14.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 15, 2010
• First Posted (Estimate): June 16, 2010

Study Record Updates

• Last Update Posted (Estimate): October 21, 2010
• Last Update Submitted That Met QC Criteria: October 20, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Dietary Intake; Capillary recruitment; Cephalic Phase of Insulin Secretion
• Other Study ID Numbers: do200812