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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01243879
Enrollment
12
Registered
2010-11-19
Start date
2008-07-31
Completion date
2009-03-31
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Calorie Restriction

Keywords

fasting, starvation, calorie restriction, fMRI

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.

Interventions

OTHERStimuli of food smell and vision

60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues

OTHERNo stimuli of food smell and vision

60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues

Sponsors

Center for Medical Systems Biology
CollaboratorUNKNOWN
Roba Metals BV, IJsselstein
CollaboratorUNKNOWN
Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Endocrine and metabolic outcomes4 weeksThe effects of odors and / or visual stimuli of food in subjects after 60h of starvation on: endocrine parameters, metabolic parameters, anthropometric parameters

Secondary

MeasureTime frameDescription
functional Magnetic Resonance Imaging4 weeksThe effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026