Scientific Documents

Water-soluble tomato concentrate (WSTC I and II) and platelet aggregation [1]

Summary (31 KB)

Opinion (91 KB)

Summary

Following an application from Provexis Natural Products Limited submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to water-soluble tomato concentrate (WSTC I and II) and reduction of platelet aggregation.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and/or claim including a request for the protection of proprietary data. 

The food constituent that is the subject of the health claim is a lycopene-free and fat-free water-soluble tomato concentrate (WSTC) developed in two variant forms named WSTC I (completely water-soluble syrup) and its low-sugar derivative, WSTC II, supplied in powder format. The WSTCs are standardised on the total quantity of 37 identified constituents which have been shown to inhibit platelet aggregation in vitro to different degrees. The Panel considers that the food constituents WSTC I and II are sufficiently characterized. 

The claimed effect is “reduction in platelet aggregation”. The target population is healthy adults between 35 and 70 years of age. The Panel considers that maintaining normal platelet aggregation is beneficial to human health.

The substantiation of the claimed effect is based on eight human studies (seven claimed as proprietary and conducted with WSTC) and seven (three claimed as proprietary) non human studies.

In the seven human intervention studies claimed as proprietary, the effects of WSTC on platelet aggregation ex vivo was investigated in carefully selected male and female subjects between 35 and 70 years of age. The Panel considers that both the selection of subjects and the method used to assess platelet aggregation were appropriate for such studies. 

In a double-blinded randomized controlled trial (RCT), a significant reduction (compared to placebo) of 8-25% in platelet aggregation was observed 3 h after consuming tomato extract corresponding to 3 g and 9 g of WSTC I in 200 mL orange juice. In a single-blinded crossover RCT a significant reduction (compared to placebo) in platelet aggregation was observed between 1.5 and 3 h after consumption of the 9 g WSTC I in either 50 or 250 mL of orange juice, which persisted for 12 h. In a non controlled crossover study platelet aggregation was inhibited by 7-8 % at 12 h, but returned to baseline values at 18 and 24 h following consumption of a single dose of 3 g of WSTC I. In a double-blinded, crossover RCT, platelet aggregation was significantly reduced (compared to tomato-free control drink) after 14 and 28 days of daily consumption 3 g of WSTC I in 200 mL orange juice.

In a crossover RCT a significant reduction in platelet aggregation was observed 3 h after consuming a single dose of 250 mL (but not with a single dose of 1L) of a fruit juice drink containing 12 g of WSTC I/L. Repeating the test after subjects had consumed 1L of the WSTC drink daily for 5 days resulted in a similar outcome. In a pilot, non-controlled study platelet aggregation was significantly reduced (compared to baseline) 3 h after consuming a single dose of 3 g of WSTC I in 250 mL orange juice and after a single dose of 150 mg or 600 mg of WSTC II in 100 mL yoghurt drink, with no significant differences between the three preparations. In a double-blind, crossover RCT, platelet aggregation was reduced (compared to control and baseline) by a similar amount (13.5-17.2 %) 3 h after consuming 3 g WSTC I (syrup), 150 mg of WSTC II (powder) produced at ambient temperature or 150 mg of WSTC II (powder) produced at 65°C. 

These human studies consistently show a reduction in platelet aggregation following consumption of WSTC under the conditions of use proposed by the applicant. Possible confounding factors likely to interfere with platelet aggregation were adequately addressed. Prothrombin and thrombin clotting times were not affected by supplementation with WSTC.

A double-blinded, parallel RCT showing a significant decrease (26.5%) in platelet aggregation following consumption of 250 mL filtered tomato juice (not WSTC) in diabetic subjects as compared to controls and seven non human studies identifying 37 compounds in aqueous tomato extracts with inhibitory activity against platelet aggregation in vitro were presented as supporting evidence. 

The Panel notes a consistent effect of the supplementation with WSTC on platelet aggregation which is sustained for up to 28 days in subjects that are representative of the target population for which the claim is intended.
The Panel concludes that a cause and effect relationship has been established between the consumption of water-soluble tomato concentrate (i.e., WSTC I and II corresponding to the specifications provided by the applicant) and the reduction in platelet aggregation in humans. 

The Panel could not have reached this conclusion without considering the studies claimed by the applicant as proprietary.
The following wording reflects the scientific evidence: “helps maintain normal platelet aggregation”.

In order to achieve the claimed effect, 3 g WSTC I or 150 mg WSTC II in up to 250 mL of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) should be consumed daily. The target population is adults between 35 and 70 years of age.