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

This study has been completed.
Sponsor:
Collaborators:
Center for Medical Systems Biology
Roba Metals BV, IJsselstein
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01243879
First received: November 18, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention
Calorie Restriction
Aging
 Other: Starvation

Study Type: Interventional
Official Title: The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • 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, antropometric parameters


Secondary Outcome Measures:
  • fMRI
    The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity


Arms Assigned Interventions
No Intervention: Fasting with stimuli
Fasting in the presence of food-related stimuli
 Other: Starvation
60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
No Intervention: Fasting without stimuli
Fasting in the absence of food-related stimuli
 Other: Starvation
60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: H. Pijl, MD PhD
ClinicalTrials.gov Identifier: NCT01243879     History of Changes
Other Study ID Numbers: P08.077
Study First Received: November 18, 2010
Last Updated: November 18, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
fasting
starvation
calorie restriction
fMRI

ClinicalTrials.gov processed this record on May 23, 2013