Method Optimization for the Quantification of the NAD

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.

Study Overview

• Status: Completed
• Conditions: NAD
• Intervention / Treatment: Other: Laboratory method validation

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • Clinical Innovation Lab.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Director: Cuenoud Bernard, Nestle Health Science

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: NAD quantification in blood and urine
• Other Study ID Numbers: 2112NR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No