1、,General presentation 介绍,Stress management through nutrition 减压,2,IDI Overview 公司概述,Turnover: 235m 营业额：2.3亿欧元 Export sales: 70% 出口销售额：70% Commercial presence in more than 120 counties 产品广销120个国家 Annual production: 100,000MT of dairy ingredients 年生产量：10万吨乳制品 Range of products: dairy powders, function
2、al systems, milk proteins产品范围：乳制品，功能性食品原料，乳蛋白,3,Introduction 简介Scientific evidence 科学依据Regulatory status 法规现状Technological data 技术数据Marketing potential 潜在市场Conclusion 结论,Table of contents 目录,June 2008,Introduction 简介,5,Introduction,What is stress ? 压力是什么？,“ Without stress there would be no life” Han
3、s Selye 压力无处不在Stress is not a disease but a stimulus. It is an unavoidable natural reaction of the body and the mind to everyday tension and pressure. 压力并不是一种病而是对人的一种刺激，它是对人体、人脑的紧张状态不可避免的一种自然反应。 Stress is both - universal: everyone is subject to stress 压力是普遍的：每个人都容易感觉有压力- individual: people respond
4、to stress in different ways. 压力又是个别的：人们对待压力的反应各不相同 When stress is not well-managed, instability is generated and stress-related disorders appear. 当压力没有得到很好的控制时，不稳定性将会产生，压力有关的失调紊乱也会出现。 Consumers cannot or do not want to stop stress, but rather regulate its symptoms.人们通常不可避免产生压力（或则希望有些压力），但希望可以调节它的症状。
5、,6,Lactium was developed by Ingredia Nutritionals scientists, in collaboration with research institutes since 1990.自1990年起， Lactium由Ingredia营养公司与研究所一起研发的。 The baseline of this research was the simple observation of the calm state of a baby after breastfeeding.研究的基准是观察母乳喂养的婴儿的情绪状态。 Researchers wanted
6、 to find a relationship between the consumption of milk and this soothing state.研究者希望能找出饮用牛奶与平复情绪之间的关系。 After many years of research and several clinical and toxicological studies, they succeeded in identifying within a milk protein, a bio-peptide with natural relaxing properties, that can be isolat
7、ed thanks to a typical hydrolysis.经过多年的研究、若干次临床试验和毒理性试验，他们成功的鉴定了在牛奶蛋白中天然十缩氨酸（是一种孤立的水解蛋白）具有减压（令人心情放松）的生理活性。,How a baby discovered Lactium Lactium是如何被婴儿发现的,Introduction,7,Lactium is a milk protein hydrolysate that contains a bioactive decapeptide with relaxing properties.Lactium是牛奶蛋白的水解产物，它包含了具有生物活性的十
8、缩氨酸，其具有令人放松的作用。 The adult enzymatic system cannot release this bioactive peptide anymore. That is why taking Lactium is the natural solution to calm down.由于成人体内的酶系统不能释放出具有生物活性的十缩氨酸，就是为什么服用 Lactium是一种让人减压的天然方法。 Lactium has been clinically proven to be efficient on stress symptoms reduction.Lactium拥有临
9、床研究证明其对减轻压力上具有功效。 Lactium does not suppress stress factors 并非是抑制压力产生 but it decreases stress-related symptoms而是减轻与压力有关的症状 and helps cope with occasional and everyday stress.也是帮助您面对偶然或每天的压力,Lactium is a unique, natural and efficient solution to help consumers deal with stress-related symptoms.,Confor
10、mation of the bioactive decapeptide (-casozepine),What is Lactium ?,Introduction,8,How does Lactium work ? 如何起效？,Lactiums action: 起效Positioning on stress symptoms: prevention or improvement of:对于压力症状的定位：预防还是改善,Chronic pain due to chronic stress 长期病痛导致长期性压力,Sleep disorders 睡眠失调,Digestive disorders du
11、e to occasional stress 食欲不调导致偶然性压力,Mood disorders 情绪失控,Impaired memory & concentration 记忆力或注意力下降,Relationship troubles e.g. libido decrease 相关性困扰如：性欲下降,Weight management 体重控制,State of tension e.g. quit smoking 紧张如：戒烟,STRESS RELEASE 压力的释放,Occasional stress: exams, diet, 偶然性压力：考试，节食,Chronic stress: ev
12、eryday life 长期性压力：日常生活中,Introduction,9,Lactium is one of the few ingredients that have received a French health claim authorization from the French Safety and Control Administration DGCCRF (French General Directorate for Competition Policy, Consumer Affairs and Fraud Control) approved by the AFSSA (
13、French Food Safety Agency):Lactium是少数通过了法国安全控制监督局健康认证的一个食品原料（法国：竞争、消费和抑制欺诈总理事会食品管制） peut modrer la rponse tensionnelle au stress, notamment chez les personnes particulirement sensibles . can moderate the tensional response to stress, in particular for hypersensitive persons. 它可以平复由压力产生的紧张情绪，特别是对于过分敏
14、感的人群. Moreover, Lactium is on the EHPM/CIAA list, waiting to receive a European health claim authorization from the EFSA (European Food Safety Agency) in 2010 (EEC Regulation 1924/2006 art. 13). As it is considered level 5, Lactium has the highest chances of receiving this European health claim auth
15、orization.而且，已在LactiumEHPM/CIAA名单中（等待EFSA欧洲食品安全局的健康认证），在此名单中Lactium是最有希望通过认证的。 Lactium also benefits from a Korean health claim authorization:Lactium通过了韩国的健康认证 Milk hydrolysate (Lactium) can release the tension by stress Australian TGA authorization 澳大利亚治疗用品管理局认证,Lactium: acknowledged efficacy 功效被承认
16、,Introduction,June 2008,Scientific evidence 科学依据,11,Scientific evidence,Lactium: proven efficacy on humans 人体实验证明有效性,6 clinical studies carried out on 234 volunteers 通过了6次临床研究（234名志愿者） All clinical trials were performed according to Good Clinical Practices Guidelines and under official ethical commi
17、ttees scrutiny. They were all performed on healthy human volunteers, using validated biological indicators and randomized, double-blind and placebo-controlled procedures. Necker Hospital, 1999: 1999年Necker医院 9 volunteers 9名志愿者 150 to 1250mg of Lactium as a single oral intake 一次性服用150-1250mg Lactium
18、1 day period 1天Optimed, 1999: 1999年Optimed 24 volunteers (12 males + 12 females) 20 to 35 years old 20-35岁的24名志愿者（男女各12名） 150mg of Lactium as a daily oral intake 每日口服150mg Lactium 15 days period 15天Necker Hospital, 2000: 2000年Necker医院 42 male volunteers 18 to 35 years old 42名男性志愿者（18-35岁） 2 x 400mg
19、of Lactium the first day and 1 x 400mg of Lactium the second day 第一天口服2次每次400mg Lactium ，第二天口服1次400mg Lactium 2 days period 2天,12,Scientific evidence,CRSSA, 2001: 52 volunteers (25 males + 27 females) 18 to 40 years old 52名志愿者 （年龄18-40岁，25名男性27名女性 ） 150mg of Lactium as a daily oral intake 每日口服150mg
20、Lactium 30 days period + 12 days wash-out 服用30天，后12停止服用 Proclaim, 2003: 63 female volunteers 18 to 61 years old 63名女性志愿者 年龄18-61岁 150mg of Lactium as a daily oral intake 日口服150mg Lactium 30 days cross-over + 3 weeks wash-out 30天交叉服用，后3周停止服用IGHD, 2006: 44 mixed volunteers 25 to 40 years old 44名志愿者-年龄
21、25-40岁 150mg of Lactium as a daily oral intake 每日口服150mg Lactium 4 weeks period + 1 week wash-out 连续4周，后1周停止服用,Lactium: proven efficacy on humans 人体实验证明有效性,13,Scientific evidence,1. Evaluation of Lactium effect on basal metabolism and side effects at different dosages. Necker Hospital, 1999.评估服用不同剂量
22、的Lactium在人体中的新陈代谢及其副作用。 (150 to 1250mg of Lactium administered p.o. 1 day - 9 volunteers) （1天服用150-1250mgLactium-9名志愿者） Lactium has no side effects on humans even at high dosages (1250mg).证明即使在服用很高剂量（1250mg）的Lactium对人体无副作用。2. Evaluation of Lactium anti-stress effect. Optimed, 1999.评估的Lactium抗压作用 (15
23、0mg of Lactium p.o. 15 days 24 volunteers) - Stress induced by stroop test.（ 15天服用150mgLactium-24名志愿者）-通过实验诱发压力 Lactium decreases the anxiety-state score.Lactium可以减轻焦虑状态,Lactium: proven efficacy on humans 人体实验证明有效性,14,3. Lactium anti-stress effect in a short-time study. Necker Hospital, 2000. 研究Lact
24、ium短期内对于抗压的效果 (Lactium p.o. - 1st day: 400mg x 2, 2nd day: 400mg x 1 42 volunteers) - Stroop test.（第一天服用2次每次400mg，第二天服用1次每次400mg-42名志愿者）Lactium significantly moderates the SBP (-31.9% vs. placebo), DBP (-28.9% vs. placebo) and blood cortisol response to stress (-21.3% after 3h).Lactium有效地调节了收缩压SBP(-
25、31.9% 比空白组)、舒张压DBP(-28.9%比空白组)和血液中的皮质醇(服用后3小时下降21.3% ),Scientific evidence,Lactium: proven efficacy on humans 人体实验证明有效性,15,4. Lactium anti-stress effect in a long-time study. CRSSA, 2001.研究Lactium长期内对于抗压的效果 (150mg of Lactium p.o. - 30 days + 12 days wash-out 52 volunteers) - Stroop test.（连续30天每日服用15
26、0mg Lactium ，后12天停止服用-52名志愿者）Lactium significantly reduces the MBP (Mean Blood Pressure) response to stress. 服用Lactium可以有效降低面临压力的平均血压 Lactium has an anti-stress effect at 150mg/day. 有效剂量150mg每天,Scientific evidence,Lactium: proven efficacy on humans 人体实验证明有效性,16,5. Lactium efficacy on stress symptoms
27、 among stressed women. Proclaim, 2003. Lactium针对女性的抗压效果(150mg of Lactium p.o. 30 days + 3 weeks wash-out cross-over 63 volunteers)（连续30天每日服用150mg，后3周停止服用-63名志愿者）,Scientific evidence,Lactium significantly improves each category of stress-related symptoms. Lactium能够有效的改善每种压力症状,Lactium: proven efficacy
28、 on humans 人体实验证明有效性,17,6. Efficacy of Lactium on sleep disorders among poor sleepers. IGHD, 2006. Lactium对于睡眠失调或睡眠质量差的人的功效 (150mg of Lactium p.o. 4 weeks + 1 week wash-out 44 volunteers)（连续4周每日服用150mg Lactium ，后1周停止服用-44名志愿者） Lactium increases: subjective sleep quality (+30.6% after 4 weeks) 睡眠质量4周
29、后提升30.6% sleep duration (+25% after 4 weeks) 睡眠时间4周后增加25% sleep efficiency (+73.1% after 4 weeks) 睡眠效率4周后增加73.1% Lactium reduces: sleep latency (-25.1% after 4 weeks) 进入睡眠时间4周后减少25.1% sleep disturbances (-38.1% after 4 weeks) 睡眠易醒程度4周后减少38.1% daytime dysfunctions (Epworth scale) (-21.1% after 4 week
30、s)白天功能不良（Epworth量表）4周后减少21.1% global PSQI score (Pittsburg Sleep Quality Index) (-31.3% after 4 weeks).全球匹兹堡睡眠品质指标数据4周后下降31.3%,Scientific evidence,Lactium progressively enhances sleep without being soporific and improves diurnal alertness. Lactium可以不依靠安眠药的帮助，逐渐增加睡眠质量，提高白天的工率,Lactium: proven efficacy
31、 on humans 人体实验证明有效性,18,Lactium efficacy on stress symptoms among stressed women. Proclaim, 2003. Lactium针对女性的抗压效果 Lactium improves stress-related weight disorders (+42% vs. placebo).Lactium可以改善由压力引起的体重失调（与对照组相比改善率达42%） Influence of stress on food intake among rats. 2006.动物实验 (15mg of Lactium/kg p.o
32、. 2 days；按体重每公斤服用15mg-连续2天)Stress (caused by a fast period of 48h) increases food intake.压力导致食欲增加 Lactium restores normal food intake levels. 使你恢复到正常食量,Focus on weight management through Lactium Lactium针对体重控制,Scientific evidence,- Unstressed group - Stressed group - Stressed group + Lactium,+53%,foo
33、d intake,time,N.S.,*,19,Influence of stress on sweet nibbling among rats. 2007.动物实验 (15mg of Lactium/kg p.o. 3 weeks 每日按体重每公斤服用15mg，连续3周)Chronic mild stress unbalances food intake and increases sweet nibbling.长期性的压力、食物摄入量不均衡、增加甜食摄入量 Lactium restores normal food intake composition.Lactium可以让你恢复正常食量 L
34、actium restores normal fat mass levels.Lactium恢复正常体重,Focus on weight management through Lactium Lactium针对体重控制,Scientific evidence,Sweet water consumption (g/kg),Fat mass (% body mass),-46%,*,*,- Unstressed group - Stressed group - Stressed group + Lactium,20,Lactium efficacy on stress symptoms among
35、 stressed women. Proclaim, 2003. Lactium针对女性的抗压效果 Lactium improves stress-related sleep disorders (+21% vs. placebo).Lactium改善睡眠失调（相比空白组21%） Lactium and sleep quality on rats. Benjamin Guesdon, 2005.（动物实验）针对睡眠质量 (15mg of Lactium/kg p.o. 2 days 每日按体重每公斤服用15mg，连续2天) Stress reduces sleep duration and q
36、uality. 压力减少了睡眠时间与降低睡眠质量 Lactium restores normal sleep duration and quality. 恢复正常睡眠时间与睡眠质量 Efficacy of Lactium on sleep disorders among poor sleepers. IGHD, 2006. 针对睡眠质量较差的人群，改善睡眠紊乱的功效 Lactium significantly increases sleep duration, quality and efficacy.Lactium有效增长睡眠时间，提高睡眠质量 Lactium significantly r
37、educes sleep disturbances, daytime dysfunction and Global PSQI score (Pittsburg Sleep Quality Index). 减少睡眠不安，白天功能不良PSQI指数,Lactium is efficient at 150 mg/day and shows significant improvements on stress-related symptoms.,Focus on sleep improvement through Lactium Lactium 针对改善睡眠,Scientific evidence,21
38、,Emeline, Student, 24,I have felt quite less nervous, less tense since Ive taken Lactium and I feel much more energetic,Cline, Not working, 36,With Lactium, I was less anguished, feeling good about myself, I was falling asleep more easily and I was not tired in the morning,milie, Student, 21,I felt
39、a drop in my usual state of stress, and I did not feel any side effect,Patricia, Working, 38,My nights are longer and their quality is higher. I attach less importance to my daily problems,Michelle, Retired, 57,Lactium gives a feeling of well-being, especially for the first days: I have been feeling
40、 more quiet and more relaxed,Consumers testify the efficacy of Lactium 消费者证明的有效性,Scientific evidence,22,Lactium: no toxicity 无毒性,No acute, sub-chronic or chronic toxicity无急性、潜在的长期性、长期性毒性 (p.o. administration, OECD guidelines) Acute toxicity (2000mg/kg = efficient dose x 130 1 day): Lactium was eithe
41、r classified as Hazard category 5 or unclassified, with a LD50 2000mg/kg.急性毒性实验（按每公斤体重服用2000mg，相当于有效剂量的130倍-1天）， Lactium的半数致死率大于2000mg/kg。 Sub-chronic (40, 200 and 1000mg/kg - 28 days) and chronic toxicity (40, 250 and 1000mg/kg - 91 days): no observable toxic effects even at 1000mg/kg/d.潜在的长期性毒性（按每
42、公斤体重服用40，200，1000mg-28天），长期性毒性（按每公斤体重服用40，250，1000mg-91天）：观察表明即使在高剂量下也无毒性。 Further studies 进一步研究 No mutagenicity: no mutagenic effect observed in vitro in mammalian cells, either with or without metabolic activity. 无诱变性：体外哺乳动物细胞实验 No teratogenicity (15mg/kg p.o. - all gestation long): neither genera
43、l nor visceral malformation in young rats. 无致畸性（孕期中服用剂量每公斤体重15mg） No behavioral toxicity (15mg/kg p.o. - all gestation long): neither change in gestating rats, nor alteration in the development of their broods.无行为毒性（孕期中服用剂量每公斤体重15mg ）,Scientific evidence,23,and no side effects 无副作用,p.o. administrati
44、on of Lactium on rats showed 动物实验: No memory loss (Social memory test) 记忆损伤 No habituation (Conditioned defensive burying test (CDB) 无依赖性 No addiction (Conditioned place preference test) 无上瘾性 No sedation (No weight increase i.e. no decrease of physical activity)无镇静（不增加体重，不减少体能活动） No disinhibition (C
45、DB and Elevated plus maze (EPM) models) 无去抑制 Neither psychological nor somatic side effects tested on rats and confirmed on humans through the Hopkins symptom checklist.动物（老鼠）实验表明无心理或生理上的副作用，人体通过贺普金斯症状检核表 Neither loss of alertness nor muscular reactivity tested on rats and confirmed on humans throug
46、h the Thayer questionnaire.动物（老鼠）实验表明无肌肉性反应，人体通过赛耶调查 Lactium is a milk protein hydrolysate so it is hypoallergenic. It contains little lactose (1%) and therefore presents low risks of lactose intolerance.它是水解牛奶蛋白，低变应原。含有少量乳糖（小于1%），出现乳糖不耐症的几率较小,Lactium shows no toxicity and no side effects.,Scientifi
47、c evidence,Regulatory status 法规现状,25,Efficacy recognized by Authorities 权威认可 Lactium is one of the few ingredients that have received a French health claim authorization from the French Safety and Control Administration DGCCRF, approved by the AFSSA:Lactium是少数通过了法国安全控制监督局健康认证的一个食品原料 can moderate the
48、 tensional response to stress, in particular for hypertensive persons. Moreover, Lactium is on the EHPM/CIAA list (level 5), waiting to receive a European health claim authorization from the EFSA in 2010.而且，已在LactiumEHPM/CIAA名单中（等待EFSA欧洲食品安全局的健康认证），在此名单中Lactium是最有希望通过认证的。 Lactium also benefits from
49、a Korean health claim authorization: Lactium通过了韩国的健康认证 Milk hydrolysate (Lactium) can release the tension by stress Australian TGA authorization 澳大利亚治疗用品管理局认证 A food grade ingredient 食品级原料 Europe: not classified as Novel food USA: - GRAS (Generally Recognized As Safe公认无毒) status, FDA approved (peptone category蛋白目录) - NDI (New Dietary Ingredient新膳食原料) approved (# rpt242) A clean label 清晰的标签 Europe and Asia: milk protein hydrolysate 水解乳蛋白 USA: casein hydrolysate 水解酪蛋白,
