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

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.

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Key information

Conditions

Calorie Restriction Aging Behavior Fasting Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Starvation

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimuli of food smell and vision

Other

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

Other names: Stimuli

No stimuli of food smell and vision

Other

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

Other names: No Stimuli

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

Center for Medical Systems Biology
Roba Metals BV, IJsselstein

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 19, 2010
Registry last updated: Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed