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Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

NCT ID: NCT01145027

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-08-31

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).

Detailed Description

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Conditions

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Microvascular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Breakfast tray

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

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Rio de Janeiro State University

Principal Investigators

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Caroline Buss, Master

Role: PRINCIPAL_INVESTIGATOR

Rio de Janeiro State University

Locations

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Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22197630 (View on PubMed)

Other Identifiers

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do200812

Identifier Type: -

Identifier Source: org_study_id