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

NCT ID: NCT01243879

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-03-31

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.

Conditions

Calorie Restriction; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fasting with stimuli

Fasting in the presence of food-related stimuli

Group Type: ACTIVE_COMPARATOR

Stimuli of food smell and vision

Intervention Type: OTHER

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

Fasting without stimuli

Fasting in the absence of food-related stimuli

Group Type: SHAM_COMPARATOR

No stimuli of food smell and vision

Intervention Type: OTHER

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

Interventions

Stimuli of food smell and vision

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

Intervention Type: OTHER

No stimuli of food smell and vision

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

Intervention Type: OTHER

Other Intervention Names

Stimuli; No Stimuli

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Medical Systems Biology

UNKNOWN

Sponsor Role: collaborator

Roba Metals BV, IJsselstein

UNKNOWN

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hanno Pijl

Prof. dr. H. Pijl

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P08.077

Identifier Type: -

Identifier Source: org_study_id