ID 1580 - 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.

2.4. Zwiększenie wydolności fizycznej (ID 1580, 1581)

The claimed effects are “increasing exercise lactate threshold and VO2 peak”, and “HMB and aerobic metabolism”. The Panel assumes that the target population is adults performing endurance exercise.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to an increase in endurance performance. Endurance performance relates to the ability to complete certain tasks with higher intensity, faster, or with a higher power output when performing long-term exercise.
The Panel considers that an increase in endurance performance 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).

3.4. Zwiększenie wydolności fizycznej (ID 1580, 1581)

Two of the human intervention studies provided assessed the effects of HMB on measures of maximal oxygen consumption (VO2 max), on ventilatory threshold or on the onset of blood lactate accumulation (Lamboley et al., 2007; Vukovich and Dreifort, 2001), but the studies did not include any measure of endurance performance. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
In a RCT by O’Connor and Crowe (2003), the effects of a 6-week oral supplementation with HMB (3.0 g/day) vs. a mixture of HMB and creatine monohydrate (3.0 g/day HMB plus 3.0 g/day creatine) on aerobic and anaerobic capacity, peak power and total work during a cycling test in highly trained
rugby players were assessed. The control group was self-selected and received no treatment. The Panel notes that randomisation and blinding were only applied to subjects assigned to the two intervention groups. No statistically significant effect of HMB on peak power or total work was observed compared to the control group. The Panel notes the important limitations of the study design, and considers that no conclusions can be drawn for the scientific substantiation of the claim.
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 increase in endurance performance.

Warunki i możliwe ograniczenia stosowania oświadczenia

The product must contain at least 1 gram HMB per serving Claim to be used for foods for active individuals

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