NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy

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).

Conditions

• Healthy

Interventions

DIETARY_SUPPLEMENT

Nicotinamide Riboside (NR)

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 healthy individuals (3 men and 3 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 spectroscopic assays. 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.

DIETARY_SUPPLEMENT

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 healthy individuals (3 men and 3 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 spectroscopic assays. 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.

DIETARY_SUPPLEMENT

Nicotinamide Riboside (NR)

A total of n=6 healthy individuals (3 men and 3 women) will receive NR 1200 mg per day for 4 weeks, followed by 3 weeks of washout. The individuals will undergo repeated blood sampling and 31P-MRS brain scans once per week during the 7 weeks period, Blood will be analyzed for NAD-metabolites using spectroscopic assays.

DIETARY_SUPPLEMENT

Nicotinamide Riboside (NR)

A total of n=6 individuals with Parkinson's disease (3 men and 3 women) will receive NR 1200 mg per day for 4 weeks, followed by 3 weeks of washout. The individuals will undergo repeated blood sampling and 31P-MRS brain scans once per week during the 7 weeks period, Blood will be analyzed for NAD-metabolites using spectroscopic assays.

Sponsors & Collaborators

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Charalampos Tzoulis, MD, PhD · Haukeland University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

35 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-17

Primary Completion

2024-03-04

Completion

2024-03-04

Countries

• Norway

Study Locations