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

Not Applicable

Completed

• Conditions: Calorie Restriction; Aging
• Interventions: Other: No stimuli of food smell and vision; Other: Stimuli of food smell and vision

• Registration Number: NCT01243879
• Lead Sponsor: Leiden University Medical Center

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 available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasting without stimuli	No stimuli of food smell and vision	Fasting in the absence of food-related stimuli
Fasting with stimuli	Stimuli of food smell and vision	Fasting in the presence of food-related stimuli

Primary Outcome Measures

Name	Time	Method
Endocrine and metabolic outcomes	4 weeks	The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on: endocrine parameters, metabolic parameters, anthropometric parameters

Secondary Outcome Measures

Name	Time	Method
functional Magnetic Resonance Imaging	4 weeks	The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity