Method Optimization for the Quantification of the NAD

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05561712
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Actual Duration (Days): 18
• Patients Per Site Per Month: 16.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
NAD	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 Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Feb 25, 2022
• Actual Primary Completion Date: Mar 15, 2022
• Actual Study Completion Date: Mar 15, 2022

Outcome Measures

Primary Outcome Measures

1. Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants. [through study completion, an average of 1 year]

   NAD metabolites in whole blood will be quantified by liquid chromatography-tandem

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Innovation Lab.	Lausanne		Switzerland

Sponsors and Collaborators

• Nestlé

Investigators

• Study Director: Cuenoud Bernard, Nestle Health Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT05561712
• Other Study ID Numbers: 2112NR
• First Posted: Sep 30, 2022
• Last Update Posted: Sep 30, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nestlé: NAD quantification in blood and urine

Study Results

No Results Posted as of Sep 30, 2022