Clincosm LogoSign in Get a demo

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

Sponsor
Leiden University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01243879
Collaborator
Center for Medical Systems Biology (Other), Roba Metals BV, IJsselstein (Other)
12
Enrollment
2
Arms
8
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stimuli of food smell and vision
  • Other: No stimuli of food smell and vision
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fasting with stimuli

Fasting in the presence of food-related stimuli

Other: Stimuli of food smell and vision
60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
Other Names:
  • Stimuli

    		•
    Sham Comparator: Fasting without stimuli

    Fasting in the absence of food-related stimuli

    Other: No stimuli of food smell and vision
    60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
    Other Names:
  • No Stimuli

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Leiden University Medical Center
    • Center for Medical Systems Biology
    • Roba Metals BV, IJsselstein

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanno Pijl, Prof. dr. H. Pijl, Leiden University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01243879
    Other Study ID Numbers:
    • P08.077
    First Posted:
    Nov 19, 2010
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Hanno Pijl, Prof. dr. H. Pijl, Leiden University Medical Center
    fasting
    starvation
    calorie restriction
    fMRI

    Study Results

    No Results Posted as of Feb 21, 2020