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

Study Overview
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Brief Summary
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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.

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

Conditions
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Calorie Restriction, Aging

Intervention / Treatment
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* Other: Stimuli of food smell and vision
* Other: No stimuli of food smell and vision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fasting with stimuli<br>Fasting in the presence of food-related stimuli | Other: Stimuli of food smell and vision<br>* 60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues<br>* Other names: Stimuli;|
| Sham Comparator: Fasting without stimuli<br>Fasting in the absence of food-related stimuli | Other: No stimuli of food smell and vision<br>* 60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues<br>* Other names: No Stimuli;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, anthropometric parameters | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional Magnetic Resonance Imaging | The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting, starvation, calorie restriction, fMRI