Nutrient Sensing During a Prolonged FastNCT01387919
Time Course and Nature of Nutrient Sensing During Fasting in Humans
A study testing Prolonged fasting in people with Nutrient Sensing During a Prolonged Fast, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Several studies have begun to determine the time course of events sensing energy availability in rodents. In contrast, there is not a single study that has examined this in humans to date. Read more about this study
- Who is it for?
- Ages 19 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrient Sensing During a Prolonged Fast
- What is being tested?
- Prolonged fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2011to Mar 2011
- 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 19 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 19-29 years old
- Body mass index (BMI) 19-25 kg/m2
- Stable weight for the last 3 months
- Caucasian
- Fasting plasma glucose (FPG) < 6 mmol/L
Show all 10Show fewer
- Well-controlled blood pressure (< 150/95 mmHg)
- Creatinine <100 umol/l
- Hb > 7.5 mmol/l
- Negative family history (first degree) of type 2 diabetes mellitus (DM2)
Who cannot join
- Use of medication known to affect glucose metabolism (for example prednisone) or lipid metabolism
- Significant (chronic) disease
- Smoking (current)
- Alcohol consumption of more than 14 units per week at present or in the past
- Difficult accessible veins for insertion of an intravenous catheter
- 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
- Rigorous exercise/sports 5 or more days a week
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
Several studies have begun to determine the time course of events sensing energy availability in rodents. In contrast, there is not a single study that has examined this in humans to date. A better understanding of this energy sensing machinery in humans is of utmost importance to give us new insights into developing new therapies for common diseases such as obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases, disturbances in the energy-sensing machinery possibly play a role. To determine the time course of energy sensing events in humans, the investigators will measure the concentration of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time points during starvation in humans. The investigators choose to study the molecular machinery in muscle, since muscle is very sensitive to fuel deprivation.
- Conditions
- Nutrient Sensing During a Prolonged Fast
- Being tested
- Prolonged fasting
- Keywords
- Set time points during 48 hours of fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged fastingBehavioural
48 hours of fasting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | healthy young and lean men Receives: Behavioral: Prolonged fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting
Measured: 1.5h, 4h, 10h, 24h
Secondary outcomes (1)
Change in several hormones, lipids etc. from blood samples upon fasting
Measured: 1.5h, 4h, 10h, 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient Sensing During a Prolonged FastStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Medical Systems Biology
- Investigators
- Hanno Pijl, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387919
- Sponsor's protocol ID
- P10.164
- Status last verified
- Jan 2011
- First submitted
- 1 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course and Nature of Nutrient Sensing During Fasting in Humans
- ClinicalTrials.gov ID
- NCT01387919
- Acronym / sponsor ID
- P10.164
- Conditions
- Nutrient Sensing During a Prolonged Fast
- Keywords
- Set time points during 48 hours of fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Centre for Medical Systems Biology
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Jul 2011 (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.
Several studies have begun to determine the time course of events sensing energy availability in rodents. In contrast, there is not a single study that has examined this in humans to date. A better understanding of this energy sensing machinery in humans is of utmost importance to give us new insights into developing new therapies for common diseases such as obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases, disturbances in the energy-sensing machinery possibly play a role. To determine the time course of energy sensing events in humans, the investigators will measure the concentration of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time points during starvation in humans. The investigators choose to study the molecular machinery in muscle, since muscle is very sensitive to fuel deprivation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Prolonged fastinghealthy young and lean men |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy males
- Age 19-29 years old
- Body mass index (BMI) 19-25 kg/m2
- Stable weight for the last 3 months
- Caucasian
Key exclusion criteria (8 listed)
- Use of medication known to affect glucose metabolism (for example prednisone) or lipid metabolism
- Significant (chronic) disease
- Smoking (current)
- Alcohol consumption of more than 14 units per week at present or in the past
- Difficult accessible veins for insertion of an intravenous catheter
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 |
|---|---|---|
| Prolonged fasting48 hours of fasting | Behavioural | 1 |
Primary outcome
Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting
Time frame: 1.5h, 4h, 10h, 24h
1 secondary outcome
Change in several hormones, lipids etc. from blood samples upon fasting
Time frame: 1.5h, 4h, 10h, 24h
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 11 Jul 2011.
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.
Hanno Pijl, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged fasting in people with Nutrient Sensing During a Prolonged Fast, run by Leiden University Medical Center at 1 site in Netherlands.
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 10 inclusion and 8 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 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting (time frame: 1.5h, 4h, 10h, 24h). 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 11 Jul 2011.