NCT01243879

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

November 18, 2010

Last Update Submit

February 19, 2020

Conditions

Calorie RestrictionAging

Keywords

fastingstarvationcalorie restrictionfMRI

Outcome Measures

Primary Outcomes (1)

  • 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, anthropometric parameters

    4 weeks

Secondary Outcomes (1)

  • functional Magnetic Resonance Imaging

    4 weeks

Study Arms (2)

Fasting with stimuli

ACTIVE COMPARATOR

Fasting in the presence of food-related stimuli

Other: Stimuli of food smell and vision

Fasting without stimuli

SHAM COMPARATOR

Fasting in the absence of food-related stimuli

Other: No stimuli of food smell and vision

Interventions

Stimuli of food smell and visionOTHER

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

Also known as: Stimuli
Fasting with stimuli
No stimuli of food smell and visionOTHER

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

Also known as: No Stimuli
Fasting without stimuli

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FastingStarvation

Interventions

Vision, OcularStimuli Responsive Polymers

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Light Signal TransductionSignal TransductionBiochemical PhenomenaChemical PhenomenaCell Physiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOcular Physiological PhenomenaPolymersMacromolecular SubstancesSmart MaterialsBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. H. Pijl

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 21, 2020

Record last verified: 2020-02