NADNCT05561712
Method Optimization for the Quantification of the NAD
An observational study of NAD, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- NAD
- What is being tested?
- Laboratory method validation
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Feb 2022to 15 Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Healthy men and women (based on anamnesis),
- Age between 18 and 55 years,
- Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 28 kg/m2.
Who cannot join
- Pregnant or lactating women
- Sick or with a strong cold
- With vitamin B3 supplementations or under low carbohydrate of ketogenic diet
- Under prescribed chronic medication, except contraceptive pill.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Method Optimization for the Quantification of the NAD (Nicotinamide Adenine Dinucleotide) Metabolome in Human Whole Blood, Plasma, and Urine, and Evaluation of Baseline Inter and Intra-subject Variability
Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability.
Read the detailed description
Whole blood from healthy participants will be collected to optimize analytical method based on liquid chromatography tandem mass spectrometry (LC-MS/MS) for the analysis of the NAD metabolome in biological samples. Parameters such as collection volume and anti-coagulants will be investigated for optimal quantification. Moreover, inter- and intra-subject variability of NAD metabolite levels in whole blood will be evaluated. Plasma and urine will also collected for method development and variability measurements.
- Conditions
- NAD
- Being tested
- Laboratory method validation
- Keywords
- NAD quantification in blood and urine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory method validationOther
Test several sampling conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants.
NAD metabolites in whole blood will be quantified by liquid chromatography-tandem
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Estimation of inter- and intra-subject variabilities of NAD metabolites in whole blood
Descriptive estimates of the inter and intra subjects variances will be calculated with the standard formulas.
Measured: through study completion, an average of 1 year
Validation of the method for a set of NAD metabolites in plasma and urine (including determination of Limit Of Detection-LOD, Limit Of Quantification- LOQ).
NAD metabolites in urine and in blood will be quantified to enable to measure several validation parameters, such as intra and interday precision, LOD, LOQ, r2.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start25 Feb 2022
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NADStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cuenoud Bernard, Study director, Nestle Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561712
- Sponsor's protocol ID
- 2112NR
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2022
- Last updated
- 30 Sep 2022
- 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method Optimization for the Quantification of the NAD (Nicotinamide Adenine Dinucleotide) Metabolome in Human Whole Blood, Plasma, and Urine, and Evaluation of Baseline Inter and Intra-subject Variability
- ClinicalTrials.gov ID
- NCT05561712
- Acronym / sponsor ID
- 2112NR
- Conditions
- NAD
- Keywords
- NAD quantification in blood and urine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 30 Sep 2022 (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.
Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability.
Detailed description
Whole blood from healthy participants will be collected to optimize analytical method based on liquid chromatography tandem mass spectrometry (LC-MS/MS) for the analysis of the NAD metabolome in biological samples. Parameters such as collection volume and anti-coagulants will be investigated for optimal quantification. Moreover, inter- and intra-subject variability of NAD metabolite levels in whole blood will be evaluated. Plasma and urine will also collected for method development and variability measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Healthy men and women (based on anamnesis),
- Age between 18 and 55 years,
- Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 28 kg/m2.
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Sick or with a strong cold
- With vitamin B3 supplementations or under low carbohydrate of ketogenic diet
- Under prescribed chronic medication, except contraceptive pill.
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 |
|---|---|---|
| Laboratory method validationTest several sampling conditions | Other | – |
Primary outcome
Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants.
Time frame: through study completion, an average of 1 year
NAD metabolites in whole blood will be quantified by liquid chromatography-tandem
2 secondary outcomes
Estimation of inter- and intra-subject variabilities of NAD metabolites in whole blood
Time frame: through study completion, an average of 1 year
Validation of the method for a set of NAD metabolites in plasma and urine (including determination of Limit Of Detection-LOD, Limit Of Quantification- LOQ).
Time frame: through study completion, an average of 1 year
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 30 Sep 2022.
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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.
Cuenoud Bernard study director
Nestle Health Science
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 NAD, run by Société des Produits Nestlé (SPN) 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 3 inclusion and 4 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 30 Sep 2022. 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?
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?
Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants. (time frame: through study completion, an average of 1 year). 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 30 Sep 2022.