Dietary Carnosine Supplementation in Healthy Human Volunteers: A Safety, Tolerability, Plasma and Brain Concentration Study.

Ali AN, Su L, Newton J, Grayson AK, Taggart D, Bell SM, Baig S, Gardner I, de Courten B, Majid A

Nutrients27 Jun 2025Cited by 3 (Europe PMC)

PMID40647235PMCIDPMC12252343DOI10.3390/nu17132130PepBankPUB-40647235

Summary

BackgroundCarnosine is a multimodal pleotropic endogenous molecule that exhibits properties that make it a compelling therapeutic agent for further evaluation in a number of diseases. However, little data currently exists on its pharmacokinetic profile, maximum tolerated doses, side effects and whether oral administration can lead to elevated brain concentrations.MethodTo investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics. A subset (n = 5) underwent Proton Magnetic Resonance Imaging (MRI) spectroscopy to evaluate the effect of oral dosing on brain carnosine concentrations, and another subset (n = 4) completed a long-term (4-week) dosing study.ResultsOral carnosine was safe and well tolerated up to a dose of 10 g. At doses of 15 g, the frequency of adverse events became unacceptably high, with 77% of participants experiencing side effects, most commonly headache (43.5%), nausea (21.7%) and paraesthesia (21.7%). While pharmacokinetic profiles varied between individuals, peak plasma concentrations occurred within the first hour of dosing. Little circulating carnosine was detectable beyond 4 h. Brain carnosine concentration increased at 1 h post-dose but reverted to baseline values by 5 h. Long-term dosing at 5 g twice daily did not result in any adverse events.ConclusionsOur data will inform dosing interventions in future clinical trials of this exciting agent.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanNon-randomized trialPharmacokinetics
In healthy volunteers, peak plasma carnosine concentrations occurred within the first hour after oral dosing.
In plain wordsIn healthy volunteers, blood carnosine peaked within the first hour after oral dosing.
Peptide
L-carnosine
Outcome
Not applicableTime to peak plasma concentration
Study
n = 16
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
Time to peak plasma concentration
≤ 1 h
oral carnosine dosing in healthy volunteers
Source sentences
Summary
While pharmacokinetic profiles varied between individuals, peak plasma concentrations occurred within the first hour of dosing.
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723506
02HumanNon-randomized trialPharmacokinetics
In healthy volunteers, little circulating carnosine remained detectable beyond 4 h after dosing.
In plain wordsIn healthy volunteers, little blood carnosine remained detectable beyond 4 h after dosing.
Peptide
L-carnosine
Outcome
Not applicableCirculating carnosine beyond 4 h
Study
n = 16
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
Little circulating carnosine was detectable beyond 4 h.
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723507
03HumanNon-randomized trialPharmacokinetics
In healthy volunteers, brain carnosine increased at 1 h after oral dosing.
In plain wordsIn healthy volunteers, brain carnosine increased at 1 h after oral dosing.
Peptide
L-carnosine
Outcome
IncreaseBrain carnosine at 1 h
Study
n = 5
Outcome group
Pharmacokinetics · Nervous system and cognition
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
Brain carnosine concentration increased at 1 h post-dose but reverted to baseline values by 5 h.
2 context sentences(design, population, supporting numbers)
Summary · context
A subset (n = 5) underwent Proton Magnetic Resonance Imaging (MRI) spectroscopy to evaluate the effect of oral dosing on brain carnosine concentrations, and another subset (n = 4) completed a long-term (4-week) dosing study.
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723508
04HumanNon-randomized trialPharmacokinetics
In healthy volunteers, brain carnosine reverted to baseline by 5 h after dosing.
In plain wordsIn healthy volunteers, brain carnosine returned to baseline by 5 h after dosing.
Peptide
L-carnosine
Outcome
No significant changeBrain carnosine at 5 h
Study
n = 5
Outcome group
Pharmacokinetics · Nervous system and cognition
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
Brain carnosine concentration increased at 1 h post-dose but reverted to baseline values by 5 h.
2 context sentences(design, population, supporting numbers)
Summary · context
A subset (n = 5) underwent Proton Magnetic Resonance Imaging (MRI) spectroscopy to evaluate the effect of oral dosing on brain carnosine concentrations, and another subset (n = 4) completed a long-term (4-week) dosing study.
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723509
05HumanNon-randomized trialSafety outcome
In healthy volunteers, carnosine at 5 g twice daily for 4 weeks produced no adverse events.
In plain wordsIn healthy volunteers, carnosine at 5 g twice daily for 4 weeks produced no adverse events.
Peptide
L-carnosine
Outcome
Not applicableAdverse events with long-term dosing
Study
n = 4
Outcome group
Adverse events · Whole body
Studied dose
5 g twice daily · oral · 4 weeksAs given in this study (human).
Source sentences
Summary
Long-term dosing at 5 g twice daily did not result in any adverse events.
2 context sentences(design, population, supporting numbers)
Summary · context
A subset (n = 5) underwent Proton Magnetic Resonance Imaging (MRI) spectroscopy to evaluate the effect of oral dosing on brain carnosine concentrations, and another subset (n = 4) completed a long-term (4-week) dosing study.
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723510
06HumanNon-randomized trialSafety outcome
In healthy volunteers, oral carnosine was safe and well tolerated up to 10 g.
In plain wordsIn healthy volunteers, oral carnosine was safe and well tolerated up to 10 g.
Peptide
L-carnosine
Outcome
Not applicableSafety and tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
up to 10 g · oralAs given in this study (human).
Source sentences
Summary
Oral carnosine was safe and well tolerated up to a dose of 10 g.
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723501
07HumanNon-randomized trialSafety outcome
In healthy volunteers, 77% experienced side effects at a carnosine dose of 15 g.
In plain wordsIn healthy volunteers, 77% experienced side effects with 15 g carnosine.
Peptide
L-carnosine
Outcome
Not applicableAny side effects
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15 g · oralAs given in this study (human).
Measurements
Side effects
77%
15 g
Source sentences
Summary
At doses of 15 g, the frequency of adverse events became unacceptably high, with 77% of participants experiencing side effects, most commonly headache (43.5%), nausea (21.7%) and paraesthesia (21.7%).
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723502
08HumanNon-randomized trialSafety outcome
In healthy volunteers, headache occurred in 43.5% at a carnosine dose of 15 g.
In plain wordsIn healthy volunteers, headache occurred in 43.5% with 15 g carnosine.
Peptide
L-carnosine
Outcome
Not applicableHeadache
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15 g · oralAs given in this study (human).
Measurements
Headache
43.5%
15 g
Source sentences
Summary
At doses of 15 g, the frequency of adverse events became unacceptably high, with 77% of participants experiencing side effects, most commonly headache (43.5%), nausea (21.7%) and paraesthesia (21.7%).
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723503
09HumanNon-randomized trialSafety outcome
In healthy volunteers, nausea occurred in 21.7% at a carnosine dose of 15 g.
In plain wordsIn healthy volunteers, nausea occurred in 21.7% with 15 g carnosine.
Peptide
L-carnosine
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
15 g · oralAs given in this study (human).
Measurements
Nausea
21.7%
15 g
Source sentences
Summary
At doses of 15 g, the frequency of adverse events became unacceptably high, with 77% of participants experiencing side effects, most commonly headache (43.5%), nausea (21.7%) and paraesthesia (21.7%).
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723504
10HumanNon-randomized trialSafety outcome
In healthy volunteers, paraesthesia occurred in 21.7% at a carnosine dose of 15 g.
In plain wordsIn healthy volunteers, paraesthesia occurred in 21.7% with 15 g carnosine.
Peptide
L-carnosine
Outcome
Not applicableParaesthesia
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15 g · oralAs given in this study (human).
Measurements
Paraesthesia
21.7%
15 g
Source sentences
Summary
At doses of 15 g, the frequency of adverse events became unacceptably high, with 77% of participants experiencing side effects, most commonly headache (43.5%), nausea (21.7%) and paraesthesia (21.7%).
1 context sentence(design, population, supporting numbers)
Summary · context
To investigate this, sixteen healthy volunteers underwent a single dose-escalation study of oral carnosine to establish safety, tolerability, and pharmacokinetics.
Show in the study text Report a problemFND-4064723505

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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