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Completed

NCT Number: NCT05561712

Method Optimization for the Quantification of the NAD

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

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Key information

Conditions

NAD

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Innovation Lab.

Lausanne, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Laboratory method validation

Other

Test several sampling conditions

Primary outcomes

  1. 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

Secondary outcomes

  1. Estimation of inter- and intra-subject variabilities of NAD metabolites in whole blood

    Time frame: through study completion, an average of 1 year

    Descriptive estimates of the inter and intra subjects variances will be calculated with the standard formulas.

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2022
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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