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

February 19, 2020 updated by: Hanno Pijl, Leiden University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endocrine and metabolic outcomes
Time Frame: 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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional Magnetic Resonance Imaging
Time Frame: 4 weeks
The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Center for Medical Systems Biology
Roba Metals BV, IJsselstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P08.077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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