A Patented Dietary Supplement (Hydroxy-Methyl-Butyrate, Carnosine, Magnesium, Butyrate, Lactoferrin) Is a Promising Therapeutic Target for Age-Related Sarcopenia through the Regulation of Gut Permeability: A Randomized Controlled Trial.

Rondanelli M, Gasparri C, Cavioni A, Sivieri C, Barrile GC, Mansueto F, Perna S

Nutrients30 Apr 2024Cited by 15 (Europe PMC)

PMID38732615PMCIDPMC11085744DOI10.3390/nu16091369PepBankPUB-38732615

Summary

Adequate diet, physical activity, and dietary supplementation with muscle-targeted food for special medical purposes (FSMP) or dietary supplement (DS) are currently considered fundamental pillars in sarcopenia treatment. The aim of this study is to evaluate the effectiveness of a DS (containing hydroxy-methyl-butyrate, carnosine, and magnesium, for its action on muscle function and protein synthesis and butyrate and lactoferrin for their contribution to the regulation of gut permeability and antioxidant/anti-inflammation activity) on muscle mass (assessed by dual X-ray absorptiometry (DXA)), muscle function (by handgrip test, chair test, short physical performance battery (SPPB) test, and walking speed test), inflammation (tumor necrosis factor-alpha (TNF-a), C-reactive protein (CRP), and visceral adipose tissue (VAT)) and gut axis (by zonulin). A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28). The skeletal muscle index (SMI) significantly improved in the supplemented group compared to the placebo one, +1.02 (CI 95%: -0.77; 1.26), p = 0.001; a significant reduction in VAT was observed in the intervention group, -70.91 g (-13.13; -4.70), p = 0.036. Regarding muscle function, all the tests significantly improved (p = 0.001) in the supplemented group compared to the placebo one. CRP, zonulin, and TNF-alpha significantly decreased (p = 0.001) in intervention, compared to placebo, -0.74 mg/dL (CI 95%: -1.30; -0.18), -0.30 ng/mL (CI 95%: -0.37; -0.23), -6.45 pg/mL (CI 95%: -8.71; -4.18), respectively. This DS improves muscle mass and function, and the gut muscle has emerged as a new intervention target for sarcopenia.

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

Results from this study9

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone9

In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking L-carnosine.

01HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the multi-ingredient supplement containing carnosine improved skeletal muscle index compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine improved skeletal muscle index compared with placebo.
Peptide
L-carnosine
Outcome
IncreaseSkeletal muscle index
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body composition · Musculoskeletal
Measurements
SMI change
1.02
p
0.001
Source sentences
Summary
The skeletal muscle index (SMI) significantly improved in the supplemented group compared to the placebo one, +1.02 (CI 95%: -0.77; 1.26), p = 0.001; a significant reduction in VAT was observed in the intervention group, -70.91 g (-13.13; -4.70), p = 0.036.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this study is to evaluate the effectiveness of a DS (containing hydroxy-methyl-butyrate, carnosine, and magnesium, for its action on muscle function and protein synthesis and butyrate and lactoferrin for their contribution to the regulation of gut permeability and antioxidant/anti-inflammation activity)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261501
02HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the multi-ingredient supplement containing carnosine reduced visceral adipose tissue compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine reduced visceral fat compared with placebo.
Peptide
L-carnosine
Outcome
DecreaseVisceral adipose tissue
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Measurements
VAT change
−70.91 g
p
0.036
Source sentences
Summary
The skeletal muscle index (SMI) significantly improved in the supplemented group compared to the placebo one, +1.02 (CI 95%: -0.77; 1.26), p = 0.001; a significant reduction in VAT was observed in the intervention group, -70.91 g (-13.13; -4.70), p = 0.036.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261502
03HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine improved handgrip performance compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine improved handgrip performance compared with placebo.
Peptide
L-carnosine
Outcome
IncreaseHandgrip test
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Musculoskeletal
Source sentences
Summary
Regarding muscle function, all the tests significantly improved (p = 0.001) in the supplemented group compared to the placebo one.
2 context sentences(design, population, supporting numbers)
Summary · context
muscle function (by handgrip test, chair test, short physical performance battery (SPPB) test, and walking speed test)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261503
04HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine improved chair-test performance compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine improved chair-test performance compared with placebo.
Peptide
L-carnosine
Outcome
IncreaseChair test
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Musculoskeletal
Source sentences
Summary
Regarding muscle function, all the tests significantly improved (p = 0.001) in the supplemented group compared to the placebo one.
2 context sentences(design, population, supporting numbers)
Summary · context
muscle function (by handgrip test, chair test, short physical performance battery (SPPB) test, and walking speed test)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261504
05HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine improved short physical performance battery results compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine improved physical performance battery results compared with placebo.
Peptide
L-carnosine
Outcome
IncreaseShort physical performance battery
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Musculoskeletal
Source sentences
Summary
Regarding muscle function, all the tests significantly improved (p = 0.001) in the supplemented group compared to the placebo one.
2 context sentences(design, population, supporting numbers)
Summary · context
muscle function (by handgrip test, chair test, short physical performance battery (SPPB) test, and walking speed test)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261505
06HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine improved walking-speed test performance compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine improved walking-speed test performance compared with placebo.
Peptide
L-carnosine
Outcome
IncreaseWalking speed test
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Musculoskeletal
Source sentences
Summary
Regarding muscle function, all the tests significantly improved (p = 0.001) in the supplemented group compared to the placebo one.
2 context sentences(design, population, supporting numbers)
Summary · context
muscle function (by handgrip test, chair test, short physical performance battery (SPPB) test, and walking speed test)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261506
07HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine decreased CRP compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine decreased CRP compared with placebo.
Peptide
L-carnosine
Outcome
DecreaseCRP
Study
n: not reported in source
Comparator
Placebo
Outcome group
Inflammation markers · Immune and inflammation
Measurements
CRP change
−0.74 mg/dL
Source sentences
Summary
CRP, zonulin, and TNF-alpha significantly decreased (p = 0.001) in intervention, compared to placebo, -0.74 mg/dL (CI 95%: -1.30; -0.18), -0.30 ng/mL (CI 95%: -0.37; -0.23), -6.45 pg/mL (CI 95%: -8.71; -4.18), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261507
08HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine decreased zonulin compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine decreased zonulin compared with placebo.
Peptide
L-carnosine
Outcome
DecreaseZonulin
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal protection · Gastrointestinal
Measurements
Zonulin change
−0.3 ng/mL
Source sentences
Summary
CRP, zonulin, and TNF-alpha significantly decreased (p = 0.001) in intervention, compared to placebo, -0.74 mg/dL (CI 95%: -1.30; -0.18), -0.30 ng/mL (CI 95%: -0.37; -0.23), -6.45 pg/mL (CI 95%: -8.71; -4.18), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261508
09HumanNot a test of L-carnosine aloneRandomized controlled trialEfficacy outcome
In older participants, the supplement containing carnosine decreased TNF-alpha compared with placebo.
In plain wordsIn older participants, the supplement containing carnosine decreased TNF-alpha compared with placebo.
Peptide
L-carnosine
Outcome
DecreaseTNF-alpha
Study
n: not reported in source
Comparator
Placebo
Outcome group
Inflammation markers · Immune and inflammation
Measurements
TNF-alpha change
−6.45 pg/mL
Source sentences
Summary
CRP, zonulin, and TNF-alpha significantly decreased (p = 0.001) in intervention, compared to placebo, -0.74 mg/dL (CI 95%: -1.30; -0.18), -0.30 ng/mL (CI 95%: -0.37; -0.23), -6.45 pg/mL (CI 95%: -8.71; -4.18), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28).
In this study, L-carnosine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking L-carnosine.
Show in the study text Report a problemFND-3873261509

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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