Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
National Counsel of Technological and Scientific Development (CNPq)
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01145027
First received: June 14, 2010
Last updated: October 20, 2010
Last verified: June 2010

June 14, 2010
October 20, 2010
June 2009
August 2010   (final data collection date for primary outcome measure)
functional capillary density (number of perfused capillaries on the studied skin area) [ Time Frame: up to 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01145027 on ClinicalTrials.gov Archive Site
cephalic phase of insulin secretion (the occurence of increase in markers of this phase, such as insulin, C-peptide and pancreatic polypeptide) [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Microvascular Function
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.
  • 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
    Intervention: Other: Breakfast tray
Buss C, Kraemer-Aguiar LG, Maranhão PA, Marinho C, de Souza MG, 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. Epub 2011 Dec 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01145027
do200812
No
Caroline Buss, RD, MSc, Rio de Janeiro State University
Rio de Janeiro State University
National Counsel of Technological and Scientific Development (CNPq)
Principal Investigator: Caroline Buss, Master Rio de Janeiro State University
Rio de Janeiro State University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP