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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243879
• Other study ID #: P08.077
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2020
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Calorie Restriction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Center for Medical Systems Biology, Roba Metals BV, IJsselstein

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	functional Magnetic Resonance Imaging	The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity	4 weeks