Method Optimization for the Quantification of the NAD

NAD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561712
• Other study ID #: 2112NR
• Status: Completed
• Start date: February 25, 2022
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy men and women (based on anamnesis),

2. Age between 18 and 55 years,

3. Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 28 kg/m2.

Exclusion Criteria:

1. Pregnant or lactating women

2. Sick or with a strong cold

3. With vitamin B3 supplementations or under low carbohydrate of ketogenic diet

4. Under prescribed chronic medication, except contraceptive pill.

Related Conditions & MeSH terms

• NAD

Intervention

Other:
• Laboratory method validation
Test several sampling conditions

Locations

Country	Name	City	State
Switzerland	Clinical Innovation Lab.	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year