Lactium : the new clinical evidence of stress moderation efficacy allows considering relaxing drinks application.

Transcription

1 Lactium : the new clinical evidence of stress moderation efficacy allows considering relaxing drinks application. Lactium is a unique, 100% natural ingredient with clinically proven stress-moderating properties. Discovered by Ingredia Nutritional R&D team in collaboration with academic research a decade ago, the soothing properties of Lactium have been assessed by numerous clinical studies. Indeed, it has been clinically proven that Lactium reduces stress-related symptoms, based both on individual statements and physiological stress parameters measurements. In order to exploit the full potential of Lactium, Ingredia Nutritional keeps running new clinical trial, with the aim of collecting even more clinical evidence that will help its customers achieve persuasive communication towards end consumers while complying with current regulations. The latest 2010 study on a shorter period of use actually showed very promising results. Previous clinical studies A first study compared the stress reactivity of healthy subjects during daily consumption of Lactium (150 mg) or placebo for 30 days (Lanoir report of clinical study). Reactivity to the stress was evaluated regularly during the study (D0 (baseline), D11, D31 and D43 (12 days after the end of the supplementation)). Every time, subjects were exposed to mental stressor task and stress reactivity was assessed using physiological and psychological markers. The physiological markers were heart rate, blood pressure and salivary cortisol concentration; the psychological markers were anxiety and arousal levels assessed by questionnaires. Statistical analysis revealed that blood pressure reactivity after a mental stress was lowered by a daily oral intake of 150 mg of Lactium for 30 days. This effect was particularly significant in high stress responders. This study demonstrates Lactium efficacy for chronic stress management when used for 30 days at least. Another study, performed in the Clinical Investigation Center of Necker-Enfants Malades Hospital (Paris, France) was interested in evaluating the effects of Lactium on some physiological responses to stress in acute conditions (Messaoudi et al., 2004). Healthy human subjects consumed two 200 mg capsules of Lactium or placebo on the morning and the evening of the previous day of the test day (total of 800 mg), and two other 200 mg capsules on the morning of the test day (total of 400 mg). They were then confronted to two experimental stress tasks: a mental stress test (Stroop test) and a physical stress test (Cold Pressor test). Hemodynamic (systolic and diastolic blood pressures and heart rate) as well as biological parameters (plasmatic ACTH and cortisol concentrations) were studied to assess the anxiolytic-like effect of Lactium. Results have shown that Lactium consumption regulated hemodynamic parameters during stress tasks, with mean percentage changes of blood pressures higher in placebo group than in the Lactium one. Beneficial effects of the bioactive ingredient were also observed on cortisol concentrations. Complementary to chronic stress efficacy, this study highlights Lactium proven efficacy to cope with acute stress factors. A study performed on females with stress-related symptoms aimed to investigate if Lactium consumption would modify various symptoms in physiological, psychological and social areas (Kim et al., 2007). Lactium or placebo were provided daily at the dosage 150 mg, according to a cross-over design with two 30-day periods of supplementation separated by a 3-week wash-out period. Outcomes were assessed by self-reported questionnaires considering the previous themes, the three main areas potentially affected by stress. For each subject, the major symptom of each area was determined and followed during placebo and Lactium supplementation. 1

2 After the 30-day supplementation, Lactium at the dose of 150 mg/day induced significant improvements in five areas: digestive, cardiovascular troubles, intellectual, emotional and social troubles for the subjects who showed the highest intensities for their major symptoms. This study allows us to say that not only Latium efficacy is proven on hemodynamic factors but also its efficacy is confirmed by consumers who need it. A latest study has evaluated the efficacy of Lactium intake on sleep disorders, based on the fact that the most common occurring forms of chronic insomnia are associated with stress, anxiety and mild depression (Saint-Hilaire et al., 2009). The Lactium or placebo products were consumed daily for 28 days and subjects assessed their sleeping-disorder improvement by filling in a self-rating questionnaire. Lactium significantly improved the total score of the treated subjects. It particularly had positive impact on sleep quality, sleep latency and daytime dysfunction. As a consequence, Lactium can be used in the formulation of sleep quality improvement products. If one s stress is released, one sleeps better, naturally. The new clinical study The new study completes the scientific dossier already available on Lactium. It aims to determine the effect of mild- (14 days) and long-term (42 days) consumption of coherent daily doses of Lactium (respectively 150 or 300 mg) in general population. The main objective was to determine the effect of Lactium on the evolution of the systolic blood pressure (SBP) due to an induced stress after a consumption of 6 weeks. Secondary objectives were associated to other physiological and biological stress parameters measurements (diastolic blood pressure, heart rate, salivary cortisol) after 2 or 6 weeks of consumption. The study was based on randomized, double-blind, placebo-controlled study with 3 parallel arms. A total of 162 male and female subjects, aged from 18 to 65 years old, were recruited for this study and allocated to one of the three experimental groups: placebo, Lactium 150 mg and Lactium 300 mg. During the 6 weeks of investigation, each subject ingested one capsule containing either the placebo product or Lactium (150 mg or 300 mg) every evening about one hour before bedtime. The effect of Lactium on acute stress was studied during an induced stress task (Stroop test) whereas chronic stress was evaluated using a STAI (State Trait Anxiety Inventory) questionnaire. Both were evaluated after 2 weeks (V2) and 6 weeks (V3) of consumption.. Results of the new clinical study First of all, the results of the new study confirm the positive effect of Lactium on hemodynamic parameters at a daily intake of 150 mg. But above all, this study highlights the positive effect of Lactium at a daily intake of 300mg during 15 days. Never such results have been detailed before. During Lactium 300 mg consumption, a significant reduction of SBP at rest was observed, from right from the 1 rst week of consumption (V2: p=0.0092, diff=-2.7 mmhg; V3: p=0.0395, diff=- 2.2 mmhg). The increase of SBP during the stress situation significantly decreased during the 2

3 consumption of Lactium 300 mg. This effect was observed 2 weeks after the beginning of the product consumption (V2: p=0.0299, diff=-2.1 mmhg) and was still significant 6 weeks later (V3: p=0.0002, diff=-3.7 mmhg). For subject consuming the placebo product, a significant decrease in Figure 1: Evolution of the variation of SBP between stress situation and rest situation SBP during the stress situation was observed only at the end of the study (Figure 1). In parallel, the peak of SBP during the stress situation significantly decreased during the consumption of Lactium 300 mg, at V2 (p=0.0284, diff=-2.4 mmhg) and at V3 (p=0.0004, diff=-5.1 mmhg). Once again, this improvement appeared in placebo group only at V3. These decreases illustrate the positive effect of Lactium at a dosage of 300 mg to limit the increase of SBP during a stress situation, from 2 weeks of consumption. Very interesting results were also observed on heart rate. Indeed the average of heart rate during the stress situation significantly decreased during the consumption of Lactium 300 mg. This effect was observed at V2 (p<0.0001, diff=-4.8 bpm) and V3 (p<0.0001, diff=-4.6 bpm) (Figure 2). Figure 2: Evolution of the variation of heart rate between stress situation and rest situation After the stress situation, heart rate decreased to return to rest value. At V2, a significant product effect was observed on the variation between heart rate 3 min after the stress situation and rest value before the stress situation. This product effect was due to a significant decrease in the variation between heart rate 3 min after the stress situation and rest value, after Lactium 300 mg consumption compared with placebo (paj=0.0077, diff=-3.0bpm). Moreover intragroup analysis showed a significant decrease in the variation between heart rate 3 min after the stress situation and rest value before the stress situation, after Lactium 300 mg consumption (p=0.0032, diff=-2.8 3

4 bpm). The recovery of heart rate after stress situation was so better in Lactium 300 mg than in placebo group. Considering the effect of Lactium on chronic stress, the STAI questionnaire was used to evaluate this aspect throughout the study. This self-assessment questionnaire from Spielberger estimates the level of anxiety of a person at some point, in a given situation. After 2 weeks of Lactium 300 mg consumption, a real product effect was observed. It was related to a significant decrease in STAI score in the Lactium 300 mg group compared to placebo group (p=0.0283, diff=-2.4 a.u). This was linked to a significant lower STAI score in Lactium 300 mg group at V2 compared to V1 (p<0.0001, diff=-3.5 a.u). 4 2 Placebo (N=52) Lactium 300mg (N=55) 4 2 STAI score Variations (Vn-V1) V1 V2 V3 Figure 3: Evolution of STAI questionnaire score during the study Complementary to chronic stress efficacy, this study demonstrates Lactium efficacy for acute stress management when used for 14 days at least at a higher dosage. These results are very promising. These remarkable clinical results allow us to elaborate new uses of Lactium on the market for consumers who need to cope with stress during a short period: school exams, special events of the private or professional life, a support to withdrawal Lactium does not suppress stress factors but rather helps consumers deal with occasional or everyday stress, decreasing stress-related symptoms such as sleep disorders, impaired memory & concentration, mood disorders, weight gain. Lactium is a ready to use ingredient that can be incorporated into dietary supplements, functional foods and beverages. Lactium, the perfect ingredient for relaxation drinks that keep their promises To highlight all the potentiality of Lactium on a short period of stress, alertness and relaxation drinks could be considered as an optimal matrix. Indeed, Lactium can be easily incorporated into all kinds of beverages at a dosage in accordance with the recommended daily intake, which makes it the perfect ingredient for effective relaxation drinks. A Lactium drink to be taken at breakfast time will help consumers stay unwind all day long; a shot drink featuring Lactium to be taken when a special stressful event appears; or even an evening drink promoting sleep are some examples one can consider. Relaxation drinks, a new, fast growing trend of the beverage market Relaxation drinks are formulated to help people unwind or focus better. One can think of them as the opposite of energy drinks. Between 2000 and 2010, there was a high level of incremental innovation that ultimately led to a high level of poor product differentiation in many categories. 4

5 Innovation continues to be perceived as a key source of competitive advantage in the drinks industry. The first relaxation or alertness drinks emerged in Japan in They quickly spread to the US: 127 million litres were sold on the US market in 2010, which is actually twice what it was in 2008 (Reuters, July 2011). In the past three years, nearly 100 new relaxation drinks including different sizes and flavors have appeared on the US market, according to market-research firm Datamonitor PLC. This new trend in the beverage market has started to emerge in other countries too, such as the EU. At a time of growing health consciousness, more and more consumers are reaching for drinks they consider healthier, while turning away from carbonated soft drinks. As US consumption trends show that Americans are always willing to try out new products, relaxation drinks are set to gain further share over the next decade. By 2014, U.S. volume sales of relaxation drinks shall exceed 300 million litres, according to Zenith International experts. Overview of the relaxation drinks ingredients Relaxation drinks contain ingredients likely to promote sleep or reduce anxiety. The main ingredients found in relaxation drinks are: melatonin, a hormone that has been shown to aid sleep and fight insomnia; L-theanine, an amino acid primarily found in green tea; GABA (gamma amino butyric acid), a neurotransmitter that calms the mind; chamomile, B vitamins and minerals such as potassium, which is associated with muscle relaxation. Although most of these new drinks have not undergone clinical trials as such, at least some of their ingredients have been shown to be effective. However, these ingredients are often used at levels that may be too small to be effective. Ingredia Nutritional does not only offer the perfect ingredient for effective relaxation drinks, it also provides strong support to its clients to help them develop successful end-products. Indeed, Ingredia Nutritional has collaborated with RhönSprudel to launch Antistress, a translucent relaxation drink featuring Lactium. Ingredia Nutritional R&D highly qualified experts have provided technological support to help achieve a clear beverage. Its regulatory team has also supported successful marketing of Antistress as is in Germany. This has resulted in a trademark license agreement and the launching of the first relaxation drink featuring Lactium, now on the market. 5

6 Conclusion Many clinical studies had already assessed the efficacy of Lactium on stress symptoms moderation. Thus, Lactium had been proven to be efficient on both chronic and acute stress and the results had been confirmed by consumers who need it. Moreover, Lactium could be used to improve sleep quality: if the stress during the day is decreased, the quality of sleep is improved. Ingredia Nutritional continues to back its flagship bioactive with even more clinical research that will open new market opportunities for its customers, while complying with the regulations in force. The latest study on a shorter period of use actually has showed very promising results. Even if Lactium can be used in numerous matrixes, one possible application of these new results is the formulation of alertness and relaxing drinks, a very trendy and fast growing market. Ingredia Nutritional does not only offer the perfect ingredient for effective relaxation drinks, it also provides strong support to its clients to help them develop successful end-products. 6