ID 1586 -
Beta-hyroksy beta-metylomaślan (też z kwasem ketoizokarponowym)
PL: Beta-hyroksy beta-metylomaślan (też z kwasem ketoizokarponowym)
EN: HMB (B- hydroxy B- methylbutyrate monohydrate)
Pdf: β-hydroxy β-methylbutyrate monohydrate (with α-ketoisocaproic acid)
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is “HMB (β-hydroxy β-methylbutyrate monohydrate)” and “HMB and HMB/KIC combinations”.
From the information provided, the Panel assumes that the food constituent that is the subject of the health claims is HMB, either alone or in combination with α-ketoisocaproic acid (KIC).
β-Hydroxy β-methylbutyric acid (HMB), or β-hydroxy β-methylbutyrate, is a metabolite of the amino acid leucine. HMB can be synthesised in the human body (about 0.2-0.4 g/day) and is usually available in supplements as a calcium salt. KIC is also an intermediate metabolite of leucine. Both HMB and KIC can be measured in food by established methods.
The Panel considers that the food constituent, either HMB alone or in combination with KIC, which is the subject of the health claims, is sufficiently characterised.
2.5. Wpływ na regenerację mięśni szkieletowych (ID 1586)
The claimed effect is “HMB and normal muscle repair”. The Panel assumes that the target population is adults performing resistance exercise.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the rebuilding of structural protein within skeletal muscle tissue after exercise which has caused muscle damage.
The Panel considers that skeletal muscle tissue repair is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
Some of the references provided for the scientific substantiation of the claims evaluated in this opinion were studies and narrative reviews which addressed the effects of HMB on outcomes (e.g. fat metabolism, hepatic and renal function, and cardiovascular system function) unrelated to the claimed effects, or which did not include original data for the scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
A meta-analysis of randomised controlled trials (RCTs) (Rowlands and Thomson, 2009) on the effects of HMB on outcomes of body composition, muscle strength and muscle damage included the majority of the publications submitted, and from which conclusions could be drawn for the scientific substantiation of the claims. The meta-analysis included 10 RCTs with a parallel design and one RCT with a cross-over design (with one-week washout between interventions). In these trials (17 intervention arms), 12 intervention arms assessed measures of muscle strength, 16 intervention arms provided body composition estimates, and eight intervention arms reported on muscle damage assessed by creatine kinase (CK) concentrations. The meta-analysis comprised 394 trained (n=259) and untrained (n=135) weight lifters on resistance training for 5±6 h/week (range 3-20 h/week), and interventions lasting 3-9 weeks. The HMB dose in all but two studies was 3.0 g/day (range 1.5-6.0 g/day).
Another meta-analysis of RCTs on the effects of HMB supplementation on lean body mass and strength during resistance training, and which included a literature search from 1967 to 2001, was provided (Nissen and Sharp, 2003). This meta-analysis included only seven RCTs on HMB (and 9 intervention arms), all of which were included in the meta-analysis by Rowlands and Thomson (2009). The Panel considers that this meta-analysis does not provide evidence for the scientific substantiation of the claims in addition to that of the meta-analysis by Rowlands and Thomson (2009).
3.5. Wpływ na regenerację mięśni szkieletowych (ID 1586)
No references addressing the effects of HMB supplementation in humans on measures of skeletal muscle tissue repair were provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of HMB, either alone or in combination with KIC, and skeletal muscle tissue repair.
Warunki i możliwe ograniczenia stosowania oświadczenia
Minimum of 3g per day HMB and 0.3g KIC daily for 2 weeks (1)
