Circadian RhythmChronoBrainNCT05093088
Effect of Circadian Rhythm on Brain NAD Measured by Phosphorus Magnetic Resonance Spectroscopy at 7 Tesla
An observational study of Circadian Rhythm, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial summary
The Discovery of the circadian clock first established a genetic basis for behavior, and our understanding of circadian rhythm (CIR) has since expanded to provide molecular insights into physiology and disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2021to 31 Aug 2022
- Phase
- Observational
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy males with age between 18 and 40 years
Who may be able to join
- Healthy males with age between 18 and 40 years
- Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 25 kg/m2
- Able to understand and to sign a written informed consent prior to the study
- Informed consent signed
- Normal or corrected-to-normal vision
- Completed the Morningness-Eveningness Questionnaire (MEQ - Appendix B) and obtained a score between 30 and 70.
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- No consumption of any beverages or foods with caffeine such as coffee and tea, within 24 hours prior to and during the experiment
- No strenuous exercise the day before the experiment. No strenuous exercise on the day of the experiment.
- Completed the one-week sleeping diary over the week before the experiment (Appendix A) showing habitually good sleep, such as falling asleep no later than midnight, waking up no later than 8:00 AM, and regularly having 7-9 hours of sleep every night.
Who cannot join
- Having any metallic, electronic, magnetic, or mechanical implants, devices, or objects, for safety reason linked to magnetic field exposure:
- Aneurysm clip(s)
- Cardiac pacemaker
- Implanted cardioverter defibrillator (ICD)
- Electronic implant or device
- Magnetically-activated implant or device
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- Neurostimulation system
- Spinal cord stimulator
- Cochlear implant or implanted hearing aid
- Insulin or infusion pump
- Implanted drug infusion device, like portacath® for instance
- Any type of prosthesis or implant
- Artificial or prosthetic limb
- Any metallic fragment or foreign body
- Hearing aid
- Other implants
- Claustrophobia
- Inability to perform tasks
- Significant psychological disorders
- Performing shift work or trans-meridian travel within one month before the study initiation
- Use of medication or nutritional supplements known to affect the circadian system or the NAD levels, including NAD precursor supplements.
- Hearing disorders (for safety purpose the participant should be able to hear from the operators during MRS scans)
- Subject having a hierarchical link with the investigator or co-investigators.
- Subject does not want to be informed of fortuitous discovery that could have an effect on his health
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Center for Biomedical Imaging, École polytechnique fédérale de Lausanne (EPFL)
Lausanne, Canton of Vaud, 1015
Lijing Xin, PhD, +41216930597, lijing.xin@epfl.ch
About this study
Official title: ChronoBrain: Effect of Circadian Rhythm on Brain NAD Measured by Phosphorus Magnetic Resonance Spectroscopy at 7 Tesla
The Discovery of the circadian clock first established a genetic basis for behavior, and our understanding of circadian rhythm (CIR) has since expanded to provide molecular insights into physiology and disease. Yet the challenge remains to translate these insights regarding the role of the CIR in cells and tissues into the clinic. Many mechanistic pre-clinical experiments have shown that the CIR is directly linked with the Nicotinamide Adenine Dinucleotide (NAD) levels and the NAD redox ratio and that the NAD oscillation amplitude is diminished during aging and in the model of neurological diseases. Human ex-vivo data have also shown that NAD oscillates over time in human red blood cells. While mounting evidence in model organisms illustrate the central role of brain NAD for maintaining energy homeostasis and the CIR, similar data in human are sparse. To date, no study has been reported in human on the effect of the CIR on brain NAD levels.
NAD is a vital cofactor involved in brain bioenergetics for metabolism and Adenosine Tri-Phosphate (ATP) production, the energy currency of the brain. NAD exists in an oxidized (NAD+) or reduced (NADH) form, with NAD+/NADH (the redox ratio) being an important determinant of cytosolic and mitochondrial metabolic homeostasis. Additionally, NAD+ is a key substrate for multiple NAD+-dependent enzymes and is consumed by at least four class of enzymes involved in genomic stability, mitochondrial homeostasis, adaptive stress responses, and cell survival, including Sirtuins. Modulation of subcellular NAD+ synthesis can regulate the timing of signaling pathways. Mammalian circadian rhythms are coordinated with metabolic activity through controlled expression of Nicotinamide phosphoribosyltransferase (NAMPT). Regulation of NAMPT, in turn, results in oscillating NAD+ levels. The rhythmic oscillation of NAD+ serves as a feedback 'timer' by modulating the activities of NAD+-dependent enzymes, including sirtuins, helping to establish the periodicity of the cycles. NAMPT oscillations also dictate mitochondrial NAD+ levels and coordinate cellular respiration with awake periods. In these cases, modulation of NAMPT levels drives the rise and fall of NAD+ concentrations that serve to limit the duration of Sirtuins activity.
Read more
Fine control of neurometabolism is necessary for brain function, because neuronal firing produces dynamic changes in local energy demand. The Astrocyte Neuron Lactate Shuttle Hypothesis (ANLS) provides one way of understanding how these changing needs are met. In this model, neuronal activity increases extracellular glutamate, which stimulates increased glucose uptake and glycolysis in astrocytes. Within astrocytes, lactate is produced from pyruvate in a reversible manner by the lactate dehydrogenase enzyme in the cytoplasm. This enzyme requires NAD as a co-factor and one NADH is converted to NAD+ when one pyruvate molecule is converted to lactate. The astrocytes then release this lactate, increasing its extracellular concentration. Important to the ANLS hypothesis, lactate can be used by nearby neurons as an energy source.
Furthermore, under the influence of the CIR regulation, the human psychological and physiological functions fluctuate with time during the day. This effect has been observed in many cognitive domains, as well as in risky decision-making and reward function.
The hypothesis is that brain NAD level is modulated by the CIR and that the NAD redox ratio should increase during the day. The primary objective of this project is to determine the brain NAD status in the morning and in the afternoon. Many pre-clinical results have suggested a diurnal effect on brain NAD, yet no clinical data is available.
In this study, NAD+ and NADH level of the occipital region will be determined by 31P-MR spectroscopy at 7 T. Total NAD (tNAD) and NAD redox ratio NAD+/NADH will be calculated as well. Measurement will be conducted in the morning in the fasted state (AM session) and in the mid-afternoon (PM session) 3 hours after the lunch intake. To confirm that the AM and PM measurements are done in two different circadian states, salivary cortisol will be measured. Simultaneous detection of other energy metabolites (e.g. lactate, PCr, ATP) will be acquired for exploratory analysis. To explore how the NAD status correlates with behavioral measures of reward activation, the automatic Balloon Analogue Risk Task (BART) test will be performed at the end of each AM and PM session.
- Conditions
- Circadian Rhythm
- Keywords
- Circadian Rhythm, NAD, MRS, Lactate, reward, risk-taking
- Medical subject headings
- Risk-Taking
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain NAD (NAD+; NADH, NAD+/NADH) measured by 31P-MRS between the two time points
Measured: two time points: morning (8:00-10:00) and afternoon (15:00-17:00)
Secondary outcomes (1)
Change in brain lactate and BART test between the two time points
Measured: two time points: morning (8:00-10:00) and afternoon (15:00-17:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Health Science
- Responsible party
- Principal investigator, Lijing Xin, Ecole Polytechnique Fédérale de Lausanne
- Investigators
- Lijing Xin, PhD, Principal investigator, CIBM Center for Biomedical Imaging, École polytechnique fédérale de Lausanne (EPFL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093088
- Sponsor's protocol ID
- 2021-00907
- Acronym
- ChronoBrain
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChronoBrain: Effect of Circadian Rhythm on Brain NAD Measured by Phosphorus Magnetic Resonance Spectroscopy at 7 Tesla
- ClinicalTrials.gov ID
- NCT05093088
- Acronym / sponsor ID
- ChronoBrain / 2021-00907
- Conditions
- Circadian Rhythm
- Keywords
- Circadian Rhythm, NAD, MRS, Lactate, reward, risk-taking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Collaborators
- Nestle Health Science
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 26 Oct 2021 (actual)
- 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.
The Discovery of the circadian clock first established a genetic basis for behavior, and our understanding of circadian rhythm (CIR) has since expanded to provide molecular insights into physiology and disease. Yet the challenge remains to translate these insights regarding the role of the CIR in cells and tissues into the clinic. Many mechanistic pre-clinical experiments have shown that the CIR is directly linked with the Nicotinamide Adenine Dinucleotide (NAD) levels and the NAD redox ratio and that the NAD oscillation amplitude is diminished during aging and in the model of neurological diseases. Human ex-vivo data have also shown that NAD oscillates over time in human red blood cells. While mounting evidence in model organisms illustrate the central role of brain NAD for maintaining energy homeostasis and the CIR, similar data in human are sparse. To date, no study has been reported in human on the effect of the CIR on brain NAD levels.
NAD is a vital cofactor involved in brain bioenergetics for metabolism and Adenosine Tri-Phosphate (ATP) production, the energy currency of the brain. NAD exists in an oxidized (NAD+) or reduced (NADH) form, with NAD+/NADH (the redox ratio) being an important determinant of cytosolic and mitochondrial metabolic homeostasis. Additionally, NAD+ is a key substrate for multiple NAD+-dependent enzymes and is consumed by at least four class of enzymes involved in genomic stability, mitochondrial homeostasis, adaptive stress responses, and cell survival, including Sirtuins. Modulation of subcellular NAD+ synthesis can regulate the timing of signaling pathways. Mammalian circadian rhythms are coordinated with metabolic activity through controlled expression of Nicotinamide phosphoribosyltransferase (NAMPT). Regulation of NAMPT, in turn, results in oscillating NAD+ levels. The rhythmic oscillation of NAD+ serves as a feedback 'timer' by modulating the activities of NAD+-dependent enzymes, including sirtuins, helping to establish the periodicity of the cycles. NAMPT oscillations also dictate mitochondrial NAD+ levels and coordinate cellular respiration with awake periods. In these cases, modulation of NAMPT levels drives the rise and fall of NAD+ concentrations that serve to limit the duration of Sirtuins activity.
Fine control of neurometabolism is necessary for brain function, because neuronal firing produces dynamic changes in local energy demand. The Astrocyte Neuron Lactate Shuttle Hypothesis (ANLS) provides one way of understanding how these changing needs are met. In this model, neuronal activity increases extracellular glutamate, which stimulates increased glucose uptake and glycolysis in astrocytes. Within astrocytes, lactate is produced from pyruvate in a reversible manner by the lactate dehydrogenase enzyme in the cytoplasm. This enzyme requires NAD as a co-factor and one NADH is converted to NAD+ when one pyruvate molecule is converted to lactate. The astrocytes then release this lactate, increasing its extracellular concentration. Important to the ANLS hypothesis, lactate can be used by nearby neurons as an energy source.
Furthermore, under the influence of the CIR regulation, the human psychological and physiological functions fluctuate with time during the day. This effect has been observed in many cognitive domains, as well as in risky decision-making and reward function.
The hypothesis is that brain NAD level is modulated by the CIR and that the NAD redox ratio should increase during the day. The primary objective of this project is to determine the brain NAD status in the morning and in the afternoon. Many pre-clinical results have suggested a diurnal effect on brain NAD, yet no clinical data is available.
In this study, NAD+ and NADH level of the occipital region will be determined by 31P-MR spectroscopy at 7 T. Total NAD (tNAD) and NAD redox ratio NAD+/NADH will be calculated as well. Measurement will be conducted in the morning in the fasted state (AM session) and in the mid-afternoon (PM session) 3 hours after the lunch intake. To confirm that the AM and PM measurements are done in two different circadian states, salivary cortisol will be measured. Simultaneous detection of other energy metabolites (e.g. lactate, PCr, ATP) will be acquired for exploratory analysis. To explore how the NAD status correlates with behavioral measures of reward activation, the automatic Balloon Analogue Risk Task (BART) test will be performed at the end of each AM and PM session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy males with age between 18 and 40 years
Key inclusion criteria (9 listed)
- Healthy males with age between 18 and 40 years
- Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 25 kg/m2
- Able to understand and to sign a written informed consent prior to the study
- Informed consent signed
- Normal or corrected-to-normal vision
Key exclusion criteria (24 listed)
- Having any metallic, electronic, magnetic, or mechanical implants, devices, or objects, for safety reason linked to magnetic field exposure:
- Claustrophobia
- Inability to perform tasks
- Significant psychological disorders
- Performing shift work or trans-meridian travel within one month before the study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in brain NAD (NAD+; NADH, NAD+/NADH) measured by 31P-MRS between the two time points
Time frame: two time points: morning (8:00-10:00) and afternoon (15:00-17:00)
1 secondary outcome
Change in brain lactate and BART test between the two time points
Time frame: two time points: morning (8:00-10:00) and afternoon (15:00-17:00)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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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.
Lijing Xin, PhD principal investigator
CIBM Center for Biomedical Imaging, École polytechnique fédérale de Lausanne (EPFL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijing Xin, PhD (+41216930597, lijing.xin@epfl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain NAD (NAD+; NADH, NAD+/NADH) measured by 31P-MRS between the two time points (time frame: two time points: morning (8:00-10:00) and afternoon (15:00-17:00)). 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 26 Oct 2021.