Effects of alpha‐cyclodextrin on cholesterol control and Compound K on glycaemic control in people with pre‐diabetes: Protocol for a Phase III randomized controlled trial
Summary The prevalence of pre‐diabetes and of type 2 diabetes mellitus is increasing. Preventing disease progression is important to improve outcomes. Natural products are becoming popular alternatives to pharmaceutical products for preventative health and treatment of disease; however, the evidence...
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| Veröffentlicht in: | Clinical obesity 2019-08, Vol.9 (4), p.e12324-n/a |
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| creator | Bessell, Erica Fuller, Nicholas R. Markovic, Tania P. Burk, Jessica Picone, Tegan Hendy, Chelsea Tan, Michelle M. C. Caterson, Ian D. |
| description | Summary
The prevalence of pre‐diabetes and of type 2 diabetes mellitus is increasing. Preventing disease progression is important to improve outcomes. Natural products are becoming popular alternatives to pharmaceutical products for preventative health and treatment of disease; however, the evidence to support the use of natural alternatives for pre‐diabetes and type 2 diabetes is lacking. Two such natural medicines include alpha‐cyclodextrin (marketed as FBCx), a fibre derived from corn starch that has been found to bind triglycerides in the intestines to prevent its absorption, aiding weight maintenance and lipid control, and hydrolysed ginseng extract (marketed as GINST15), a formula containing high amounts of Compound K, a metabolite of ginsenosides thought to be an active ingredient contributing to the anti‐hyperglycaemic effects of ginseng. This paper describes the rationale and design of a 12‐month randomized controlled trial to investigate the metabolic effects of these two products in people with pre‐diabetes and overweight or obesity. A total of 400 participants will be randomized to one of four groups (FBCx + GINST15, FBCx + placebo, placebo + GINST15, placebo + placebo) for 6 months, followed by 6 months of follow‐up. Participants will also receive lifestyle advice for healthy eating and weight loss. Data collected during the trial will include weight, waist circumference, body composition and blood pressure. Blood samples will also be collected to measure lipid profile and glycaemia. If the products are found to improve lipid and glucose levels, it will provide evidence for their use in people with pre‐diabetes to help reduce the risk of progression to type 2 diabetes. |
| doi_str_mv | 10.1111/cob.12324 |
| format | Article |
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The prevalence of pre‐diabetes and of type 2 diabetes mellitus is increasing. Preventing disease progression is important to improve outcomes. Natural products are becoming popular alternatives to pharmaceutical products for preventative health and treatment of disease; however, the evidence to support the use of natural alternatives for pre‐diabetes and type 2 diabetes is lacking. Two such natural medicines include alpha‐cyclodextrin (marketed as FBCx), a fibre derived from corn starch that has been found to bind triglycerides in the intestines to prevent its absorption, aiding weight maintenance and lipid control, and hydrolysed ginseng extract (marketed as GINST15), a formula containing high amounts of Compound K, a metabolite of ginsenosides thought to be an active ingredient contributing to the anti‐hyperglycaemic effects of ginseng. This paper describes the rationale and design of a 12‐month randomized controlled trial to investigate the metabolic effects of these two products in people with pre‐diabetes and overweight or obesity. A total of 400 participants will be randomized to one of four groups (FBCx + GINST15, FBCx + placebo, placebo + GINST15, placebo + placebo) for 6 months, followed by 6 months of follow‐up. Participants will also receive lifestyle advice for healthy eating and weight loss. Data collected during the trial will include weight, waist circumference, body composition and blood pressure. Blood samples will also be collected to measure lipid profile and glycaemia. If the products are found to improve lipid and glucose levels, it will provide evidence for their use in people with pre‐diabetes to help reduce the risk of progression to type 2 diabetes.</description><identifier>ISSN: 1758-8103</identifier><identifier>EISSN: 1758-8111</identifier><identifier>DOI: 10.1111/cob.12324</identifier><identifier>PMID: 31172667</identifier><language>eng</language><publisher>Chichester, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; alpha-Cyclodextrins - administration & dosage ; alpha‐cyclodextrin ; Blood Glucose - metabolism ; Blood pressure ; Body composition ; Body weight ; Body Weight - drug effects ; Body weight loss ; Cholesterol ; Cholesterol - metabolism ; cholesterol control ; Clinical trials ; complementary medicines ; Cyclodextrin ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - prevention & control ; Female ; Ginseng ; Ginsenosides ; Ginsenosides - administration & dosage ; glycaemic control ; Health risks ; Humans ; hydrolysed ginseng ; Intestine ; Lipids ; Male ; Medical treatment ; Middle Aged ; Natural products ; Obesity - diet therapy ; Obesity - metabolism ; Overweight - drug therapy ; Overweight - metabolism ; Prediabetic State - drug therapy ; Prediabetic State - metabolism ; pre‐diabetes ; Randomization ; Starch ; Triglycerides ; Triglycerides - metabolism ; Weight loss</subject><ispartof>Clinical obesity, 2019-08, Vol.9 (4), p.e12324-n/a</ispartof><rights>2019 World Obesity Federation</rights><rights>2019 World Obesity Federation.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3534-50f6fc32746ad71a2440014e733ac0b2c7af2aaa1c91da78c13f0bb605e1dd4d3</citedby><cites>FETCH-LOGICAL-c3534-50f6fc32746ad71a2440014e733ac0b2c7af2aaa1c91da78c13f0bb605e1dd4d3</cites><orcidid>0000-0002-6823-5872 ; 0000-0002-5938-9917</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fcob.12324$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fcob.12324$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31172667$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bessell, Erica</creatorcontrib><creatorcontrib>Fuller, Nicholas R.</creatorcontrib><creatorcontrib>Markovic, Tania P.</creatorcontrib><creatorcontrib>Burk, Jessica</creatorcontrib><creatorcontrib>Picone, Tegan</creatorcontrib><creatorcontrib>Hendy, Chelsea</creatorcontrib><creatorcontrib>Tan, Michelle M. C.</creatorcontrib><creatorcontrib>Caterson, Ian D.</creatorcontrib><title>Effects of alpha‐cyclodextrin on cholesterol control and Compound K on glycaemic control in people with pre‐diabetes: Protocol for a Phase III randomized controlled trial</title><title>Clinical obesity</title><addtitle>Clin Obes</addtitle><description>Summary
The prevalence of pre‐diabetes and of type 2 diabetes mellitus is increasing. Preventing disease progression is important to improve outcomes. Natural products are becoming popular alternatives to pharmaceutical products for preventative health and treatment of disease; however, the evidence to support the use of natural alternatives for pre‐diabetes and type 2 diabetes is lacking. Two such natural medicines include alpha‐cyclodextrin (marketed as FBCx), a fibre derived from corn starch that has been found to bind triglycerides in the intestines to prevent its absorption, aiding weight maintenance and lipid control, and hydrolysed ginseng extract (marketed as GINST15), a formula containing high amounts of Compound K, a metabolite of ginsenosides thought to be an active ingredient contributing to the anti‐hyperglycaemic effects of ginseng. This paper describes the rationale and design of a 12‐month randomized controlled trial to investigate the metabolic effects of these two products in people with pre‐diabetes and overweight or obesity. A total of 400 participants will be randomized to one of four groups (FBCx + GINST15, FBCx + placebo, placebo + GINST15, placebo + placebo) for 6 months, followed by 6 months of follow‐up. Participants will also receive lifestyle advice for healthy eating and weight loss. Data collected during the trial will include weight, waist circumference, body composition and blood pressure. Blood samples will also be collected to measure lipid profile and glycaemia. If the products are found to improve lipid and glucose levels, it will provide evidence for their use in people with pre‐diabetes to help reduce the risk of progression to type 2 diabetes.</description><subject>Adult</subject><subject>alpha-Cyclodextrins - administration & dosage</subject><subject>alpha‐cyclodextrin</subject><subject>Blood Glucose - metabolism</subject><subject>Blood pressure</subject><subject>Body composition</subject><subject>Body weight</subject><subject>Body Weight - drug effects</subject><subject>Body weight loss</subject><subject>Cholesterol</subject><subject>Cholesterol - metabolism</subject><subject>cholesterol control</subject><subject>Clinical trials</subject><subject>complementary medicines</subject><subject>Cyclodextrin</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - prevention & control</subject><subject>Female</subject><subject>Ginseng</subject><subject>Ginsenosides</subject><subject>Ginsenosides - administration & dosage</subject><subject>glycaemic control</subject><subject>Health risks</subject><subject>Humans</subject><subject>hydrolysed ginseng</subject><subject>Intestine</subject><subject>Lipids</subject><subject>Male</subject><subject>Medical treatment</subject><subject>Middle Aged</subject><subject>Natural products</subject><subject>Obesity - diet therapy</subject><subject>Obesity - metabolism</subject><subject>Overweight - drug therapy</subject><subject>Overweight - metabolism</subject><subject>Prediabetic State - drug therapy</subject><subject>Prediabetic State - metabolism</subject><subject>pre‐diabetes</subject><subject>Randomization</subject><subject>Starch</subject><subject>Triglycerides</subject><subject>Triglycerides - metabolism</subject><subject>Weight loss</subject><issn>1758-8103</issn><issn>1758-8111</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9u1DAQhy0EolXpgRdAljhx2Nb_EqfcYFVgRaX2AOdoYo_ZVE4m2Fm1y4lH4El4KJ4EL9vujbnMyPr8ja0fYy-lOJOlzh11Z1JpZZ6wY2mrZtGU06eHWegjdprzrShVq_qiMs_ZkZbSqrq2x-z3ZQjo5swpcIjTGv78_OW2LpLH-zn1I6eRuzVFzDMmitzROO86jJ4vaZhoU4bPO-pb3DrAoXcHptyekKaI_K6f13xKWOS-hw5nzG_5TaKZXOECJQ78Zg0Z-Wq14qnIaeh_oH9UxTKW10B8wZ4FiBlPH_oJ-_rh8svy0-Lq-uNq-e5q4XSlzaISoQ5OK2tq8FaCMkYIadBqDU50ylkICgCku5AebOOkDqLralGh9N54fcJe771Tou-b8vn2ljZpLCtbpSqjGlHbplBv9pRLlHPC0E6pHyBtWynaXThtCaf9F05hXz0YN92A_kA-RlGA8z1w10fc_t_ULq_f75V_AbtXnVM</recordid><startdate>201908</startdate><enddate>201908</enddate><creator>Bessell, Erica</creator><creator>Fuller, Nicholas R.</creator><creator>Markovic, Tania P.</creator><creator>Burk, Jessica</creator><creator>Picone, Tegan</creator><creator>Hendy, Chelsea</creator><creator>Tan, Michelle M. C.</creator><creator>Caterson, Ian D.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TS</scope><scope>K9.</scope><orcidid>https://orcid.org/0000-0002-6823-5872</orcidid><orcidid>https://orcid.org/0000-0002-5938-9917</orcidid></search><sort><creationdate>201908</creationdate><title>Effects of alpha‐cyclodextrin on cholesterol control and Compound K on glycaemic control in people with pre‐diabetes: Protocol for a Phase III randomized controlled trial</title><author>Bessell, Erica ; Fuller, Nicholas R. ; Markovic, Tania P. ; Burk, Jessica ; Picone, Tegan ; Hendy, Chelsea ; Tan, Michelle M. C. ; Caterson, Ian D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3534-50f6fc32746ad71a2440014e733ac0b2c7af2aaa1c91da78c13f0bb605e1dd4d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>alpha-Cyclodextrins - administration & dosage</topic><topic>alpha‐cyclodextrin</topic><topic>Blood Glucose - metabolism</topic><topic>Blood pressure</topic><topic>Body composition</topic><topic>Body weight</topic><topic>Body Weight - drug effects</topic><topic>Body weight loss</topic><topic>Cholesterol</topic><topic>Cholesterol - metabolism</topic><topic>cholesterol control</topic><topic>Clinical trials</topic><topic>complementary medicines</topic><topic>Cyclodextrin</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - prevention & control</topic><topic>Female</topic><topic>Ginseng</topic><topic>Ginsenosides</topic><topic>Ginsenosides - administration & dosage</topic><topic>glycaemic control</topic><topic>Health risks</topic><topic>Humans</topic><topic>hydrolysed ginseng</topic><topic>Intestine</topic><topic>Lipids</topic><topic>Male</topic><topic>Medical treatment</topic><topic>Middle Aged</topic><topic>Natural products</topic><topic>Obesity - diet therapy</topic><topic>Obesity - metabolism</topic><topic>Overweight - drug therapy</topic><topic>Overweight - metabolism</topic><topic>Prediabetic State - drug therapy</topic><topic>Prediabetic State - metabolism</topic><topic>pre‐diabetes</topic><topic>Randomization</topic><topic>Starch</topic><topic>Triglycerides</topic><topic>Triglycerides - metabolism</topic><topic>Weight loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bessell, Erica</creatorcontrib><creatorcontrib>Fuller, Nicholas R.</creatorcontrib><creatorcontrib>Markovic, Tania P.</creatorcontrib><creatorcontrib>Burk, Jessica</creatorcontrib><creatorcontrib>Picone, Tegan</creatorcontrib><creatorcontrib>Hendy, Chelsea</creatorcontrib><creatorcontrib>Tan, Michelle M. C.</creatorcontrib><creatorcontrib>Caterson, Ian D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Physical Education Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Clinical obesity</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bessell, Erica</au><au>Fuller, Nicholas R.</au><au>Markovic, Tania P.</au><au>Burk, Jessica</au><au>Picone, Tegan</au><au>Hendy, Chelsea</au><au>Tan, Michelle M. C.</au><au>Caterson, Ian D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of alpha‐cyclodextrin on cholesterol control and Compound K on glycaemic control in people with pre‐diabetes: Protocol for a Phase III randomized controlled trial</atitle><jtitle>Clinical obesity</jtitle><addtitle>Clin Obes</addtitle><date>2019-08</date><risdate>2019</risdate><volume>9</volume><issue>4</issue><spage>e12324</spage><epage>n/a</epage><pages>e12324-n/a</pages><issn>1758-8103</issn><eissn>1758-8111</eissn><abstract>Summary
The prevalence of pre‐diabetes and of type 2 diabetes mellitus is increasing. Preventing disease progression is important to improve outcomes. Natural products are becoming popular alternatives to pharmaceutical products for preventative health and treatment of disease; however, the evidence to support the use of natural alternatives for pre‐diabetes and type 2 diabetes is lacking. Two such natural medicines include alpha‐cyclodextrin (marketed as FBCx), a fibre derived from corn starch that has been found to bind triglycerides in the intestines to prevent its absorption, aiding weight maintenance and lipid control, and hydrolysed ginseng extract (marketed as GINST15), a formula containing high amounts of Compound K, a metabolite of ginsenosides thought to be an active ingredient contributing to the anti‐hyperglycaemic effects of ginseng. This paper describes the rationale and design of a 12‐month randomized controlled trial to investigate the metabolic effects of these two products in people with pre‐diabetes and overweight or obesity. A total of 400 participants will be randomized to one of four groups (FBCx + GINST15, FBCx + placebo, placebo + GINST15, placebo + placebo) for 6 months, followed by 6 months of follow‐up. Participants will also receive lifestyle advice for healthy eating and weight loss. Data collected during the trial will include weight, waist circumference, body composition and blood pressure. Blood samples will also be collected to measure lipid profile and glycaemia. If the products are found to improve lipid and glucose levels, it will provide evidence for their use in people with pre‐diabetes to help reduce the risk of progression to type 2 diabetes.</abstract><cop>Chichester, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>31172667</pmid><doi>10.1111/cob.12324</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-6823-5872</orcidid><orcidid>https://orcid.org/0000-0002-5938-9917</orcidid></addata></record> |
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| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult alpha-Cyclodextrins - administration & dosage alpha‐cyclodextrin Blood Glucose - metabolism Blood pressure Body composition Body weight Body Weight - drug effects Body weight loss Cholesterol Cholesterol - metabolism cholesterol control Clinical trials complementary medicines Cyclodextrin Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - prevention & control Female Ginseng Ginsenosides Ginsenosides - administration & dosage glycaemic control Health risks Humans hydrolysed ginseng Intestine Lipids Male Medical treatment Middle Aged Natural products Obesity - diet therapy Obesity - metabolism Overweight - drug therapy Overweight - metabolism Prediabetic State - drug therapy Prediabetic State - metabolism pre‐diabetes Randomization Starch Triglycerides Triglycerides - metabolism Weight loss |
| title | Effects of alpha‐cyclodextrin on cholesterol control and Compound K on glycaemic control in people with pre‐diabetes: Protocol for a Phase III randomized controlled trial |
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