NCT05561712

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

18 days

First QC Date

March 3, 2022

Last Update Submit

September 27, 2022

Conditions

Keywords

NAD quantification in blood and urine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    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).

    through study completion, an average of 1 year

Interventions

Test several sampling conditions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Innovation Lab.

Lausanne, Switzerland

Location

Study Officials

  • Cuenoud Bernard

    Nestle Health Science

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

September 30, 2022

Study Start

February 25, 2022

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Locations