Calorie RestrictionNCT01243879
The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
A study testing Stimuli of food smell and vision and No stimuli of food smell and vision in people with Calorie Restriction and Aging, run by Leiden University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Calorie Restriction, Aging
- What is being tested?
- Stimuli of food smell and vision and No stimuli of food smell and vision
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
- Conditions
- Calorie Restriction, Aging
- Being tested
- Stimuli of food smell and vision, No stimuli of food smell and vision
- Keywords
- fasting, starvation, calorie restriction, fMRI
- Medical subject headings
- Fasting, Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimuli of food smell and visionOther
Also called Stimuli
60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
No stimuli of food smell and visionOther
Also called No Stimuli
60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
| Study group | Role | What they receive |
|---|---|---|
| Fasting with stimuli | Active comparator | Fasting in the presence of food-related stimuli Receives: Other: Stimuli of food smell and vision |
| Fasting without stimuli | Sham comparator | Fasting in the absence of food-related stimuli Receives: Other: No stimuli of food smell and vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
functional Magnetic Resonance Imaging
The effects of odors and / or visual stimuli of food in subjects after 60h of starvation on hypothalamic neuronal activity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calorie RestrictionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Medical Systems Biology, Roba Metals BV, IJsselstein
- Responsible party
- Principal investigator, Hanno Pijl, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243879
- Sponsor's protocol ID
- P08.077
- Status last verified
- Feb 2020
- First submitted
- 18 Nov 2010
- Last updated
- 21 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01243879
- Acronym / sponsor ID
- P08.077
- Conditions
- Calorie Restriction, Aging
- Keywords
- fasting, starvation, calorie restriction, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Center for Medical Systems Biology, Roba Metals BV, IJsselstein
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting with stimuli | Active comparator | Other: Stimuli of food smell and visionFasting in the presence of food-related stimuli |
| Fasting without stimuli | Sham comparator | Other: No stimuli of food smell and visionFasting in the absence of food-related stimuli |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimuli of food smell and visionAlso: Stimuli60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues | Other | Fasting with stimuli |
| No stimuli of food smell and visionAlso: No Stimuli60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues | Other | Fasting without stimuli |
Primary outcome
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
1 secondary outcome
functional Magnetic Resonance Imaging
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stimuli of food smell and vision and No stimuli of food smell and vision in people with Calorie Restriction and Aging, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocrine and metabolic outcomes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.