Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920825
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2021-05-26
Brief Title:
Sacha Inchi Oil Supplementation in 3Hs
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Sacha Inchi Oil Supplementation Among The 3Hs Hyperglycaemia Hypertension Hyperlipidaemia Patients A Randomised Placebo-Controlled Double-Blinded Human Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the effect of Sacha Inchi Oil supplementation among the 3Hs patients
Detailed Description:
Non-communicable diseases NCDs are the leading cause of death worldwide In Malaysia NCDs account for 67 of premature mortality and over 70 of disease burden in 2014 In 2016 NCDs were responsible for 71 of the 57 million deaths globally An estimated 78 of all NCD deaths and 85 of premature adult NCD deaths occurred in low- and middle-income countries In Malaysia NCDs contribute to 71 of premature deaths According to the Malaysian Burden of Disease and Injury Study 2009-2014 cardiovascular and circulatory diseases contributed to 348 of deaths Data from NHMS 2015 showed an increasing trend for diabetes and hypercholesterolaemia but a plateau trend for hypertension The prevalence of diabetes was from 112 2011 to 134 2015 hypertension from 327 2011 to 303 2015 and hypercholesterolaemia from 351 2011 to 477 2015
The burden of NCDs has increased substantially over the years Information from the Global Burden of Disease Study suggests that the biggest contributor amongst the modifiable behavioural risk factors is unhealthy eating The exposure to an unhealthy diet occurs throughout the lifespan of an individual and accumulates over hisher lifetime With the increasing prevalence of diabetes and the high prevalence of hypertension and hypercholesterolaemia it is unlikely that Malaysia will be able to achieve target 34 of the United Nations Sustainable Development Goals of reducing premature mortality due to NCDs At the current trajectory it is also unlikely for Malaysia to reach the nine voluntary global targets for the prevention and control of NCDs
There is an urgent need to reduce exposure to NCD risk factors amongst Malaysians There are evidences that medical nutrition therapy using nutritional supplements are recommended to treat NCDs Nutritional supplements contain biologically active ingredients associated with physiological health benefits for preventing and managing chronic diseases such as hypertension hyperlipidaemia and diabetes mellitus Natural nutraceuticals were a preferable treatment method that has been accepted by consumers and appeared to be generally safe Among the nutritional supplements used in controlling chronic diseases is the utilisation of long-chain polyunsaturated fatty acids
Fatty acids FA are hydrocarbon chains with a carboxyl group at one end and a methyl group at the other The carboxyl group is reactive and readily forms ester links with alcohol groups for example those on glycerol or cholesterol in turn forming acylglycerols eg triacylglycerols phospholipids and cholesterol esters They have a variable-length carbon chain and can be categorised based on the degree of saturation of their carbon chains Saturated fatty acids SFA possess the maximal number of hydrogen atoms while monounsaturated fatty acids MUFA have one double bond Fatty acids with double bonds in the hydrocarbon chain are referred to as unsaturated fatty acids a fatty acid with 2 or more double bonds is called polyunsaturated fatty acids PUFA The number of carbon atoms in the chain is denoted by a shorthand nomenclature and the position of the first double bond relative to the methyl called n carbon PUFA can be further subdivided based on the location of the first double bond relative to the methyl terminus of the chain For example omega-3 Ω-3 and omega-6 Ω-6 FAs are two of the most biologically significant PUFA classes and have their first double bond on either the third or sixth carbon from the chain terminus respectively Long-chain Ω-3 and Ω-6 PUFA are synthesised from the essential FAs EFAs alpha-linolenic acid ALA and linoleic acid LA respectively EFAs cannot be made by the human body and must be obtained through dietary sources However animals and humans have the capacity to metabolise EFAs to long-chain derivatives through multiple elongation and desaturation steps
A high amount of ALA can be found in many nuts Some Peruvian species that contain this compound in a high percentage is the Sacha Inchi Plukenetia Volubilis L Sacha Inchi is a plant of the Euphorbiaceous family which grows in the Amazonian forest The plant widely cultivated in Peru has been a component of various native tribal groups of the region The seeds of Sacha Inchi are of great interest because they contain approximately on average 48 oil and 27 proteins Sacha Inchi seeds have a unique fatty acid composition containing a large amount of unsaturated fatty acids about 85 polyunsaturation comprised of approximately 51 linolenic acid Ω-3 and 34 linoleic acid Ω-6 This Peruvian species has been classified as an edible oil with the highest proportion of unsaturated fatty acids7 The oil from Sacha Inchi also contains a high content of gamma- -tocopherols it is despite its high proportion of unsaturated fatty acids which in turns makes it comparably stable against oxidation Several in vivo studies have proven that Sacha Inchi can be exquisitely digested Traditionally the oil has been used in the preparation of various meals the seeds are roasted and the leaves are cooked consumed SI seeds are also used as a traditional remedy in the Amazon region to treat rheumatic problems and aching muscles Sacha Inchi oil SIO has also been identified as an important source of the healthy Ω-3 and Ω-6 linoleic acyl groups which are beneficial in controlling cardiometabolic syndrome namely coronary heart disease and hypertension showing a hypocholesterolaemic effect when used as food supplements
Literature suggests that Ω-3 and Ω-6 must co-exist or taken in the ratio of 11 which is the closest during evolution of humans in order to be beneficial for human health Common fish oil and nuts have the Ω-3 to Ω-6 variation of 5-131 and 14-16 respectively Ω-6 or linoleic acid are not favourable to be ingested in such a tilted ratio as it increases low-density lipoprotein oxidation and severity of coronary atherosclerosis Clinical studies on high Ω-6Ω-3 ratio found that when the ratio decreases the platelet aggregation the underlying mechanism of atherosclerosis also decreases A lower Ω-6Ω-3 ratio also has been found to decrease vascular endothelial growth factor Too high amount of Ω-6 also inhibits eicosapentaenoic acid incorporation from dietary Ω-3 supplements in human subjects Throughout a variety of nuts and fishes Sacha Inchi oil has a 1125 Ω-6 to Ω-3 ratio approaching the closest of ideal ratio of 11 The ideal ratio as demonstrated could be of relevance to both neurodevelopment and the prevention of neurodegeneration A target of 11 to 21 has appeared to be consistent with studies on evolutionary aspects of diet neurodevelopment and genetics
Type 2 Diabetes Mellitus T2DM hypertension and hyperlipidaemia are the most common form of NCDs in Malaysia Prescription of standard and long term medical regimen has long been implemented in managing the illnesses There is a need to search for some potential complementary medicine to combat 3Hs The use of Sacha Inchi oil as part of the dietary regimen or alternative medicine to alleviate the disease progression is the novel research focus among the scientific communities With the aforementioned this randomised placebo-controlled double-blinded human clinical trial is aimed to determine the efficacy of 12 weeks supplementation of Sacha Inchi oil a natural blend of polyunsaturated fatty acids among the 3Hs patients Secondary outcomes include the assessment of vascular implication biomarkers inflammatory markers nutritional status quality of life mental health safety and tolerability
The burden of NCDs has increased substantially over the years Information from the Global Burden of Disease Study suggests that the biggest contributor amongst the modifiable behavioural risk factors is unhealthy eating The exposure to an unhealthy diet occurs throughout the lifespan of an individual and accumulates over hisher lifetime With the increasing prevalence of diabetes and the high prevalence of hypertension and hypercholesterolaemia it is unlikely that Malaysia will be able to achieve target 34 of the United Nations Sustainable Development Goals of reducing premature mortality due to NCDs At the current trajectory it is also unlikely for Malaysia to reach the nine voluntary global targets for the prevention and control of NCDs
There is an urgent need to reduce exposure to NCD risk factors amongst Malaysians There are evidences that medical nutrition therapy using nutritional supplements are recommended to treat NCDs Nutritional supplements contain biologically active ingredients associated with physiological health benefits for preventing and managing chronic diseases such as hypertension hyperlipidaemia and diabetes mellitus Natural nutraceuticals were a preferable treatment method that has been accepted by consumers and appeared to be generally safe Among the nutritional supplements used in controlling chronic diseases is the utilisation of long-chain polyunsaturated fatty acids
Fatty acids FA are hydrocarbon chains with a carboxyl group at one end and a methyl group at the other The carboxyl group is reactive and readily forms ester links with alcohol groups for example those on glycerol or cholesterol in turn forming acylglycerols eg triacylglycerols phospholipids and cholesterol esters They have a variable-length carbon chain and can be categorised based on the degree of saturation of their carbon chains Saturated fatty acids SFA possess the maximal number of hydrogen atoms while monounsaturated fatty acids MUFA have one double bond Fatty acids with double bonds in the hydrocarbon chain are referred to as unsaturated fatty acids a fatty acid with 2 or more double bonds is called polyunsaturated fatty acids PUFA The number of carbon atoms in the chain is denoted by a shorthand nomenclature and the position of the first double bond relative to the methyl called n carbon PUFA can be further subdivided based on the location of the first double bond relative to the methyl terminus of the chain For example omega-3 Ω-3 and omega-6 Ω-6 FAs are two of the most biologically significant PUFA classes and have their first double bond on either the third or sixth carbon from the chain terminus respectively Long-chain Ω-3 and Ω-6 PUFA are synthesised from the essential FAs EFAs alpha-linolenic acid ALA and linoleic acid LA respectively EFAs cannot be made by the human body and must be obtained through dietary sources However animals and humans have the capacity to metabolise EFAs to long-chain derivatives through multiple elongation and desaturation steps
A high amount of ALA can be found in many nuts Some Peruvian species that contain this compound in a high percentage is the Sacha Inchi Plukenetia Volubilis L Sacha Inchi is a plant of the Euphorbiaceous family which grows in the Amazonian forest The plant widely cultivated in Peru has been a component of various native tribal groups of the region The seeds of Sacha Inchi are of great interest because they contain approximately on average 48 oil and 27 proteins Sacha Inchi seeds have a unique fatty acid composition containing a large amount of unsaturated fatty acids about 85 polyunsaturation comprised of approximately 51 linolenic acid Ω-3 and 34 linoleic acid Ω-6 This Peruvian species has been classified as an edible oil with the highest proportion of unsaturated fatty acids7 The oil from Sacha Inchi also contains a high content of gamma- -tocopherols it is despite its high proportion of unsaturated fatty acids which in turns makes it comparably stable against oxidation Several in vivo studies have proven that Sacha Inchi can be exquisitely digested Traditionally the oil has been used in the preparation of various meals the seeds are roasted and the leaves are cooked consumed SI seeds are also used as a traditional remedy in the Amazon region to treat rheumatic problems and aching muscles Sacha Inchi oil SIO has also been identified as an important source of the healthy Ω-3 and Ω-6 linoleic acyl groups which are beneficial in controlling cardiometabolic syndrome namely coronary heart disease and hypertension showing a hypocholesterolaemic effect when used as food supplements
Literature suggests that Ω-3 and Ω-6 must co-exist or taken in the ratio of 11 which is the closest during evolution of humans in order to be beneficial for human health Common fish oil and nuts have the Ω-3 to Ω-6 variation of 5-131 and 14-16 respectively Ω-6 or linoleic acid are not favourable to be ingested in such a tilted ratio as it increases low-density lipoprotein oxidation and severity of coronary atherosclerosis Clinical studies on high Ω-6Ω-3 ratio found that when the ratio decreases the platelet aggregation the underlying mechanism of atherosclerosis also decreases A lower Ω-6Ω-3 ratio also has been found to decrease vascular endothelial growth factor Too high amount of Ω-6 also inhibits eicosapentaenoic acid incorporation from dietary Ω-3 supplements in human subjects Throughout a variety of nuts and fishes Sacha Inchi oil has a 1125 Ω-6 to Ω-3 ratio approaching the closest of ideal ratio of 11 The ideal ratio as demonstrated could be of relevance to both neurodevelopment and the prevention of neurodegeneration A target of 11 to 21 has appeared to be consistent with studies on evolutionary aspects of diet neurodevelopment and genetics
Type 2 Diabetes Mellitus T2DM hypertension and hyperlipidaemia are the most common form of NCDs in Malaysia Prescription of standard and long term medical regimen has long been implemented in managing the illnesses There is a need to search for some potential complementary medicine to combat 3Hs The use of Sacha Inchi oil as part of the dietary regimen or alternative medicine to alleviate the disease progression is the novel research focus among the scientific communities With the aforementioned this randomised placebo-controlled double-blinded human clinical trial is aimed to determine the efficacy of 12 weeks supplementation of Sacha Inchi oil a natural blend of polyunsaturated fatty acids among the 3Hs patients Secondary outcomes include the assessment of vascular implication biomarkers inflammatory markers nutritional status quality of life mental health safety and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None