NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy

Healthy Clinical Trial

— NAD-brain  

Official title:

NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698771
• Other study ID #: 2023-496197
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2023
• Est. completion date: March 17, 2023

Study information

• Verified date: January 2023
• Source: Haukeland University Hospital
• Contact: Charalampos Tzoulis, MD, PhD
• Phone: 94392305
• Email: charalampos.tzoulis[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the NAD-brain study is to determine the blood and brain pharmacokinetics of NAD replenishment therapy (NRT) using Nicotinamide Riboside (NR) or Nicotinamide Mononucleotide (NMN).

Description:

The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects. A total of 6-10 healthy individuals (3-5 men and 3-5 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites. The simultaneous change in NAD-metabolism over time in blood and brain will be assessed and blood and brain pharmacokinetics for NRT in humans will be established.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 30-85 years at the time of enrollment.
• Neurologically healthy at the time of enrollment.

Exclusion Criteria:

• History of acute or chronic neurological disorder affecting the central nervous system (CNS). Migraine, cluster headache, and tension headache are allowed, but not on the day of the study visits.
• Impaired renal function.
• Impaired hepatic function.
• Severe hematological disease.
• Any psychiatric disorder that would interfere with compliance in the study.
• Any severe somatic illness that would make the individual unable to comply and participate in the study.
• Mitochondrial disease.
• Use of high dose vitamin B3 supplementation within 30 days of enrolment.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• nicotinamide riboside
The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects . A total of 6-10 healthy individuals (3-5 men and 3-5 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites using HPLC-MS. By this approach we will measure the simultaneous change in NAD-metabolism over time in blood and brain and establish blood and brain pharmacokinetics for NRT in humans. Based on these results we will determine the optimal dosing frequency of NRT in healthy individuals.
• nicotinamide mononucleotide
The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects . A total of 6-10 healthy individuals (3-5 men and 3-5 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites using HPLC-MS. By this approach we will measure the simultaneous change in NAD-metabolism over time in blood and brain and establish blood and brain pharmacokinetics for NRT in humans. Based on these results we will determine the optimal dosing frequency of NRT in healthy individuals.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestland

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NAD metabolism	The change of cerebral NAD levels (measured by 31P-MRS) and of blood NAD-metabolites (measured by HPLC-MS), over time (20 days), after the administration of oral NRT with the following NAD precursors: NR 600mg x 2 daily, NMN 600mg x 2 daily.	20 days for NR and 20 days for NMN
Secondary	Interindividual differences	Descriptive analyses of interindividual differences in the time course of change in the blood NAD-metabolome and cerebral NAD increase, following the administration of oral NRT.	20 days for NR and 20 days for NMN
Secondary	Between-sex differences	Between-sex differences in the time course of change in the blood NAD-metabolome and cerebral NAD increase, following the administration of oral NRT.	20 days for NR and 20 days for NMN