The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects

This study has been completed.

Sponsor:

Collaborators:

Center for Medical Systems Biology

Roba Metals BV, IJsselstein

Information provided by:

Leiden University Medical Center

ClinicalTrials.gov Identifier:

NCT01243879

First received: November 18, 2010

Last updated: NA

Last verified: November 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 18, 2010
Last Updated Date	November 18, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2010)	Endocrine and metabolic outcomes The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on: endocrine parameters, metabolic parameters, antropometric parameters
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 18, 2010)	fMRI The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
Official Title ^ICMJE	The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
Brief Summary	Calorie restriction extends life span and prevents aging-related diseases in several species. Odorants from live yeast restrain the beneficial effects of calorie restriction in Drosophila Melanogaster. The investigators hypothesize that visual and odorous food stimuli impact the neuroendocrine and metabolic response to starvation in healthy humans. In this randomized cross-over intervention study 12 healthy, young men will fast twice for 60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured by functional MRI.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Calorie Restriction Aging
Intervention ^ICMJE	Other: Starvation 60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
Study Arm (s)	No Intervention: Fasting with stimuli Fasting in the presence of food-related stimuli Intervention: Other: Starvation No Intervention: Fasting without stimuli Fasting in the absence of food-related stimuli Intervention: Other: Starvation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Caucasian male volunteers Age > 18 years and < 70 years Body mass index (BMI) > 20 kg/m2 and < 25 kg/m2 Fasting serum glucose (FSG) < 6.1 mmol/L Exclusion Criteria: Any significant chronic of hereditary disease (including renal, hepatic or endocrine disease) Any significant abnormal laboratory results found during the medical screening procedure Any use of medication (except for NSAID) Anosmia or any other (acquired) loss of olfaction (ea. rhinitis) Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months) Difficulties to insert an intravenous catheter Smoking MRI contraindications Recent blood donation (within the last 3 months) Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
Gender	Male
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01243879
Other Study ID Numbers ^ICMJE	P08.077
Has Data Monitoring Committee	Not Provided
Responsible Party	H. Pijl, MD PhD
Study Sponsor ^ICMJE	Leiden University Medical Center
Collaborators ^ICMJE	Center for Medical Systems Biology Roba Metals BV, IJsselstein
Investigators ^ICMJE	Not Provided
Information Provided By	Leiden University Medical Center
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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