J Korean Diabetes 2018;19:46-52 Vol.19, No.1, 2018 ISSN 2233-7431 이혜옥강동경희대학교병원영양팀 Understanding for Adequate Health Functional Foods for Diabetes Educators Hye Ok Lee Department of Nutrition, Kyung Hee University Hospital at Gangdong, Seoul, Korea Abstract Recently, increasing interest in health care is boosting demand for products such as immuno-enhanced products and vitamins. There is a large selection of health functional foods for use by diabetics. Diabetic patients may learn about health functional foods from people around them, internet, and TV. Therefore, diabetic educators need to impart a good understanding of health functional foods so patients do not use them indiscriminately. It is important for diabetic educators to specifically ask patients about the use of healthy functional foods in their consultations. In addition, diabetic educators should provide knowledge on the efficacy of health functional foods and the desirable information. Keywords: Diabetic educators, Diabetic patients, Functional foods 서론 당뇨병환자들은당뇨병치료를위해약물, 운동및식사요법을실천해야한다. 그러나대부분의환자들은꾸준한노력을요하는식사요법보다빠른시간안에효과가뚜렷한해결책을원하게되어건강기능식품을구입하여섭취하기 도한다. 또한연구보고에따르면건강기능식품을구입할때전문가와상담하기보다는주변지인을통한소개로구매하는경우가많다고보고되어 [1], 무분별한건강기능식품섭취에따른문제의발생가능성이높다고할수있다. 이때가장우려되는부분은건강기능식품섭취로인해필수적인당뇨병치료및자가생활관리에소홀해지기도하며또는건 Corresponding author: Hye Ok Lee Department of Nutrition, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul 05278, Korea, E-mail: hye0221@khnmc.or.kr Received: Jan. 26, 2018; Accepted: Feb. 6, 2018 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/bync/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright c 2018 Korean Diabetes Association 46 The Journal of Korean Diabetes
이혜옥 강기능식품이약물을대체할수있으리라고과신하기도한다는점이다. 2015년국내제조업총생산의전년대비성장률은 2.3% 인데반하여건강기능식품생산은무려 11.8% 나증가하는등고속성장중이다. 특히건강관리에대한관심증가로면역기능개선제품이나비타민등과같은영양보충용제품에대한수요가증가한것이건강기능식품생산증가의주요요인으로분석되고있으며 [2], 당뇨병환자의경우건강기능식품을선택하는주된목적은혈당강하와건강유지및증진에있는것으로조사되었다 [3]. 이렇게건강기능식품시장이확대되고, 최근미디어의발달로많은종류의건강기능식품들이광고, 유통되고있는상황에서당뇨병환자를위한건강기능식품에대한올바른정보제공이요구되므로, 당뇨병교육자들도당뇨병환자용건강기능식품에대한관심을가질수밖에없게되었다. 소비자안전국에서건강식품 ( 건강기능식품, 기능성표방식품, 건강식품 ) 대상으로한달간분석한정보에따르면건강기능식품섭취후부작용사례 716건중평소질환을앓고있으면서증상호전을기대하고섭취하였으나, 부작용이나타난사례는 35건이었으며, 이를질환별로분석한결과당뇨병환자가 11건으로가장많았다고보고되었다 [4]. 이를통해서도알수있듯이당뇨병환자의경우건강식품섭취비율이높고잘못된건강기능식품섭취에따른질환의악화의위험성에노출되어있음을보여주고있다. 따라서본고에서는 높은혈당에도움 을주는건강기능식품에대해알아보고, 당뇨병교육자들에게당뇨병환자교육및상담시건강기능식품선택및섭취에도움이되는올바른정보를제공하고자한다. 본론 1. 건강기능식품의올바른이해건강기능식품은일상식사에서결핍되기쉬운영양소나인체에유용한기능을가진원료나성분을사용하여제조한것을건강유지에도움을주는식품이다. 또한건강기능 식품에관한규정에따라일정절차를거쳐만들어지는제품으로건강기능식품이라는문구또는인증마크가있다 [5]. 이러한점에서 건강식품, 자연식품, 천연식품 과같은명칭은건강기능식품과는다르다. 건강기능식품의정의와범위는기능성과안전성에따라건강기능식품 < 기능성식품 < 일반식품으로건강기능식품은일반식품범위에포함되어있고, 일부는의약품범위에포함되어있다 [6]. 건강기능식품기능성원료는고시형원료와개별인정형원료두가지가존재하며, 고시형원료는식약처장이판매를목적으로하는건강기능식품의제조, 사용및보조에관한기준과규격을정하여고시하였으며, 개별인정형원료는제조자또는수입자에게서안전성및기능성등에관한자료를제출받아검토후식약처장이별로도인정한원료이다. 2016년 12 월고시형원료 95종 ( 영양소 28종, 기능성원료 67종 ), 개별인정형원료 211종이존재한다 [7]. 식품의약품안전처는 건강기능식품기능성원료및기준규격인정에관한규정 [8] 에따라건강기능식품의기능성은 3가지가있으며 ( 영양소기능, 질병발생위험감소기능, 생리활성기능 ), 이중영양소기능은인체의정상적인기능이나생물학적활동에대한영양소의생리학적적용으로분류되고, 질병발생위험감소기능과생리활성기능이기능성원료에따라등급이나누어진다. 건강기능식품의기능성원료를과학적근거가높고낮은정도에따라 4등급 ( 질병발생위험감소기능, 생리활성 1~3등급 ) 의기능성체계로분류ㆍ인정하고있다 [7. 질병발생위험감소기능은제출된기능성자료가 질병의발생위험감소에도움을줌 을나타내며, 확보된과학적근거자료의수준이과학적합의 ( 성분또는원료와건강효과간의상관성이새로운과학에의해뒤집어지지않을정도의수준으로관련분야의전문가들에의한만장일치에가까운합의수준을말함 ) 에이를수있을정도로높을경우인정하며, 생리활성기능은제출된기능성자료가인체의정상기능이나생물학적활동에특별한효과가있어건강상의기여나기능향상또는건강유지ㆍ개선을나타내는경우에인정한다. 좀더자세히살펴보면생리활성 1등급은 OO에도움을줌 으로표시되며생리학적인효 www.diabetes.or.kr 47
과가명확하게입증되어야하고일관성있는개선효과가다수의인체적용시험에서확보되어야하며, 생리활성 2등급은 OO에도움을줄수있음 으로표시되며기능성있는생리학적인효과를추측할수있어야하고개선효과가최소 1 건이상의인체적용시험에서확보되어야하며, 생리활성 3 등급은 OO에도움을줄수있으나관련인체적용시험이미흡함 으로표시되며생리학적인효과또는기전을추측할수있는자료가있으나, 인체적용시험에서기능성을확보할수없음을뜻한다. 이러한기능성원료의생리활성등급의의미를알아두는것이환자상담시도움이될수있을것이다. 또한식품의학품안전처는과학적근거중심의평가체계하에 생리활성기능 에해당하는등급들의과학적근거부족에대한지적이되면서 3등급은폐지하고, 1ㆍ2등급은기능성으로단일화하는방법을 2016년 10월에검토중인것으로보고하고있다. 이와는반대로 2016년 5월 제5차규제개혁장관회의 결과에따라산업활성화를위해건강기능식품의고시형원료를대폭확대하고인정심사기간을단축하는것등을내용으로하는규제완화를계획하고있다 [6. 따라서당뇨병교육자는이러한변화를인지하고추후변화될수있는기준에적합한건강기능식품에관심을꾸준히갖는것이필요하다. 관련인체적용시험이미흡함 이다. 기능성내용인정범위는당뇨전단계, 즉내당능장애나, 공복혈당장애가있는사람이기능성원료를섭취함으로써공복혈당감소나식후혈당감소에도움이되는것을의미하며, 혈당조절및합병증조절을해야하는환자의경우는대상에해당되지않는다는것이다 [11]. 생리활성기능 1등급 높은혈당감소에도움 의기능성에서직접적인지표인혈당감소효과는인체적용시험에서필수적으로확인되어야하며, 이때 공복혈당이높은사람에게도움 또는 식후혈당이높은사람에게도움 의기능성에따라공복혈당또는식후혈당개선효과가입증되어야한다. 또한기반연구자료에서인체적용시험결과를과학적뒷받침할수있는일관성있는바이오마커의확인이필요하고, 이를통해추측가능한작용기전을설명하는것이다 [11]. 높은혈당감소에도움을주는원료들의인정등급을보면생리활성기능 1등급은없으며, 생리활성기능 2등급또는 3등급에해당하는원료들이다. 다시표현하면 높은혈당감소에도움을줄수있음 또는높은혈당감소에도움을줄수있으나관련인체적용시험이미흡함 의등급이다. 높은혈당감소에도움 의건강기능식품기능성원료의인정현황 (No 1-11 고시형원료, No 12-29 개별인정형원료 ) 은 2016년 12월기준으로다음과같다 [7,11] (Table 1). 2. 높은혈당감소에도움 건강기능식품 3. 건강기능식품섭취시주의사항 최근 13년간 ( 04~ 16) 기능성별원료인정현황중체지방감소 27건에이어혈당조절원료인정현황이 21건 ( 최근 1건취소 ) 으로 2위를차지하고있다 [7]. Park 등 [3] 의연구에따르면당뇨환자의건강기능식품선호정도를보면홍삼 27.9%, 누에 13.6%, 비타민 10.4%, 뽕나무 7.1%, 동충하초 6.8%, 인삼 4.2% 등으로다른연구들 [9,10] 에서도상위권에있는원료들이며, 건강기능식품의고시형원료및개별인정형원료들이다. 혈당관리위한기능성인정등급의표현은생리활성기능 1등급 높은혈당감소에도움을줌, 생리활성기능 2등급 높은혈당감소에도움을줄수있음, 생리활성기능 3등급 높은혈당감소에도움을줄수있으나 1) 표시및광고기준건강기능식품의표시및광고기준은식품의약품안전청에서인정받은기능성원료를가지고만든제품인 건강기능식품 의용기ㆍ포장에는 건강기능식품에관한법률 제 17조 ( 표시기준 ) 에따라다음과같은사항을표시해야하며, 구입하여섭취할때환자들에게꼭확인할수있도록안내해야한다. 건강기능식품이라는문자또는건강기능식품임 48
이혜옥 Table 1. Helps reduce blood sugar levels Functional material of health functional foods Name of the No. material 1 Nondigestible maltodextrin Recognition level 2 Guar gum 3 Oat dietary fiber 4 Soy dietary fiber 5 Wheat dietary fiber 6 Corn bran Wheat dietary fiber 7 Inulin/chicory extract 8 Fenugreek seeds dietary fiber 9 Banaba leaf extract 10 Guavarin 11 Evening primrose seed extract 12 Pinitol Pinitol powder 13 Rhodiola rosea etc. complex extract 14 Pine leaf distillation concentrate Functional substances Corosolic acid Total polyphenol 1 Total polyphenol 2 Penta-O-galloyl beta-d-glucose Pinitol Precautions on intake 1 Rhodiola 1 Be careful about intake in pregnant women, rosea extract: lactating women, and children Salidroside 2 If you take medicine to control blood glucose, 2 Cinnamon extract: consult your doctor. Cinnamic acid 1 3-Ccarene 2 Limonene 3 terpinolene Do not use if you have bronchial asthma, cough, or severe inflammation in the lungs. www.diabetes.or.kr 49
No. Name of the material 15 Fermented soybean extract Recognition level 16 Albumin 17 Nopal extract 18 Freeze-dried silkworm powder 19 Mixed extracts of fructus aurantii and mulberry leaves 20 Rhynchosia nulubilis peptide complex 21 Ginseng hydrolysate Concentrate function level 3 22 Yam extract 23 Tagatose 24 Silk protein enzyme hydrolysate 25 Elfvingia applanata mycelium (cancellation of accept) 26 Hydroxypropyl methylcellulose 27 Mulberry leaf extract 28 Cinnamon extract Powder 29 L-arabinose Functional substances 1 α-glucosidase activation inhibitor(ic50) 2 Tris(2-amino- 2-(hydroxyl methyl)-1,3-pro panediol) 0.19-Albumin Water-soluble fiber 1-Dexynojirimycin 1 Naringin 2 Astragalin 1 Arginine 2 Leucine Precautions on intake 1 Be careful about intake of soybean due to possible allergy 2 Be careful about intake in pregnant women, lactating women, and children Be careful about intake due to possible wheat allergy Be careful about intake in pregnant women, lactating women, and children Be careful about intake of photosensitive dermatoses Ginsenoside Rg1 Be careful about intake of medicines (diabetes treatment, blood anticoagulants) Allantoin - D-tagatose Serine, glycine, alanine Excessive intake may cause gastrointestinal disorders 1 Be careful about intake due to possible liver and kidney dysfunction 2 Be careful about intake in pregnant women and children β-glucan - Hydroxypropyl methylcellulose 1-Dexynojirimycin Cinnamic acid L-arabinose Health functional foods according to the Ministry of Food and Drug Safety, 2016.12.[7]. 1 Excessive intake may cause constipation 2 Must be taken with plenty of water (excluding liquid) Be careful about intake in pregnant women and lactating women 1 Be careful about intake in pregnant women and lactating women 2 Be careful about intake due to cinnamon allergy 1 Excessive intake of sugar can be harmful 2 Excessive intake may cause diarrhea 3 If you take medicines to control blood glucose, consult your doctor. - 50
이혜옥 을나타내는도형, 기능성분또는영양소및그영양권장량에대한비율 ( 영양권장량이설정된것에한함 ), 섭취량및섭취방법, 섭취시주의사항, 유통기한및보관방법, 질병의예방및치료를위한의약품이아니라는내용의표현, 그밖에식품의약품안전청장이정하는사항을꼭확인하도록안내한다 [12]. 또한 건강기능식품에관한법률 제26조 ( 유사표시등의금지 ) 에따르면, 건강기능식품이아닌것은그용기ㆍ포장에인체의구조및기능에대한식품영양학적ㆍ생리학적기능및작용등이있는것을오인될우려가있는표시를하거나이와같은내용의광고를할수없으며, 건강기능식품과유사한표시ㆍ광고로판매하거나판매의목적으로저장또는진열하는것을금지하고있다 [12]. 건강기능식품은질병의치료효과가있는의약품이아니기때문에질병을치료하는의약품인것처럼광고하는제품구입은주의해야하며, 기능성을지나치게강조하거나장담하는형식의광고에도주의하도록교육한다. 2) 건강기능식품원료별의약품과상호작용식품의약품안전처는 2015년 12월 의약품등병용섭취로인한건강기능식품이상사례조사ㆍ분석 결과 26 개의주요건강기능식품기능성원료를대상으로의약품등과병용섭취시발생가능한 79개의부작용사례 ( 건강기능식품원료별상호작용모노그래프 ) 를확인했음을발표하였다 [13]. 이중직접적인혈당변화와관계된기능성원료는인삼 ( 인삼, 인삼가시오갈피등혼합추출물, 인삼가수분해농축액, 인삼다당체추출물 ), eicosapentaenoic acid (EPA) 및 docosahexaenoic acid (DHA) 함유유지, 밀크씨슬 ( 카르두스마리아누스 ) 추출물, 와일드망고종자추출물, 은행잎추출물 5가지이다. 주요내용은혈당감소허브종류와인삼의병용시저혈당위험증가, DHA는혈당강하제효과를방해하고영향을줄수있음, 밀크씨슬은혈당강하제와병용섭취시인슐린민감성을향상시킬수있음, 와일드망고종자추출물을혈당강하제와병용할경우저혈당이올수있음, 은행은혈당강하제와병용섭취시약물의효과및혈중수준에영향을줄수있다는내용을포함하고있다. 또한직접적인 혈당변화이외합병증관리위해사용되는약물들과의작용이다수포함되어있다. 이러한건강기능식품원료와의약품과상호작용을인지하고이에맞는조언을할수있도록한다. 3) 기타주의사항최근해외인터넷쇼핑몰등을통한직접구매또한친지를통해구입된건강기능식품이증가함에따라이에대한정보의부재가있을수있다. 따라서당뇨병환자의경우이러한제품에대한섭취여부에질문을받았을경우어떤권고를하여야할지고민스러울때가많다. 우선이러한문제해결을위해식품의약품안전처에서는 2014년에통합식품안전정보망을구축하였으며, 이중식품안전정보대국민포털사이트 식품안전나라 (http://www.foodsafetykorea. go.kr/) 를이용하여올바른정보를환자에게제공하도록한다. 식품안전나라에는식품ㆍ안전정보, 위해ㆍ예방정보, 건강ㆍ영양정보, 식품전문정보, 이슈ㆍ뉴스ㆍ홍보ㆍ교육으로이루어져있으며, 수입식품, 식품첨가물, 허위과대광고, 해외직구, 영양성분, 업체제품검색, 식품원료, 식품안전뉴스, 교육홍보자료등의정보를포함하고있다. 결론 당뇨병교육자는당뇨병환자가건강기능식품의섭취시건강을유지하거나개선하는것을목적으로하며, 의약품처럼질병의예방과치료효과를목적으로섭취하는것이아니라는것을인지하도록설명해야하고, 제품으로판매되고있는원료를구입하여추출물또는농축형태로섭취하여특정성분의과량섭취가이루어지지않도록주의하도록설명해야한다. 당뇨병환자의올바른건강기능식품선택을위해서는진료또는상담시에환자에게건강기능식품섭취를구체적으로물어보고, 적극적으로환자의민간요법또는건강기능식품사용에관심을갖고상담해주려는노력이필요할것이다. 또한당뇨병교육자는건강기능식품에대한정보와유용성에대한과학적인근거를토대로올바른정보를제공하는것과건강기능식품의이용을치료의보조역할로 www.diabetes.or.kr 51
써바람직한방향으로유도하여, 환자가건강기능식품섭취에의한부작용에노출되는위험을줄일수있도록조언하는것이당뇨병교육자로서의올바른자세라할수있겠다. REFERENCES 1. Korea Food Security Research Foundation. Available from: http://www.foodsecurity.or.kr/bbs/view. php?&bbs_id=qnaa04&page=&doc_num=112 (updated 2014 Feb 10). 2. Ministry of Food and Drug Safety, Health functional foods actual output report. Available from: http://www. mfds.go.kr/index.do?mid=675&pageno=1&seq=32955 &cmd=v (updated 2016 Aug 11). 3. Park YM, Sohn CM, Jang HC. A study on status and subjective recognition of functional foods among diabetic patients. J Korean Diet Assoc 2005;11:216-22. 4. Korea Consumer Agency. Available from: https://goo.gl/ hahded (updated 2012 Dec 21). 5. Ministry of Food and Drug Safety. Available from: http:// www.foodsafetykorea.go.kr/portal/board/boarddetail. do?menu_no=2680&bbs_no=bbs067&ntctxt_ no=1046889&menu_grp=menu_new04 (updated 2015 Aug 10). 6. Ministry of Food and Drug Safety. Available from: http:// www.mfds.go.kr/index.do?mid=627&pageno%20 =1&cmd%20=v&seq=48019 (updated 2017 Jan 19). 7. Ministry of Food and Drug Safety. Available from: http:// www.mfds.go.kr/index.do?mid=1681&seq=25805 (updated 2017 Jan 18). 8. Ministry of Food and Drug Safety. Available from: https://goo.gl/mndyhc (updated 2016 Dec 21). 9. Park SH, Wang SG. A research on anti-diabetic functional food intake of the subjects with type 2 diabetes mellitus in Daejeon. Korean J Human Ecology 2008;17:797-804. 10. Wang SG. Review of herbs and dietary supplements for glycemic control in diabetes. Nat Sci 2011;22:109-28. 11. Ministry of Food and Drug Safety. Available from: http://www.mfds.go.kr/index.do?mid=699&pageno= 17&seq=13861&cmd=v (updated 2012 Dec 18). 12. Ministry of Food and Drug Safety. Available from: http:// www.mfds.go.kr/index.do?x=0&searchkey=title:content s&mid=685&searchword=%b0%c7%b0%ad%b1%e2 %B4%C9%BD%C4%C7%B0&y=0&pageNo=2 (updated 2015 Oct 20). 13. Ministry of Food and Drug Safety. Available from: http://www.foodsafetykorea.go.kr/portal/board/board. do?menu_grp=menu_new01&menu_no=3612 (updated 2018 Feb 6). 52