Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03942822
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2019-04-25
Brief Title:
Chia Supplementation and Non Alcoholic Fatty Liver Disease
Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Organization:
Instituto Nacional de Cardiologia Ignacio Chavez
Study Overview
Official Title:
Effect of a Chia Supplemented Diet Salvia Hispanica on the Cardiometabolic Risk Profile in Patients With NAFLD Non Alcoholic Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2019-05
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:
Parallel to epidemic obesity non-alcoholic fatty liver disease NAFLD prevalence has markedly increased during the last years and recent data point out that one of three adults courses with this disease NAFLD etiopathogeny is multifactorial an inadequate diet characterized by high fructose content and deficient consumption of omega-3 fatty acids scarce physical activity excess abdominal visceral fat AVF insulin resistance and genetic susceptibility have shown to be relevant determinants Although NAFLD can progress to cirrhosis and hepatic carcinoma its most frequent complications are type 2 diabetes mellitus DM2 and coronary artery disease CAD therefore NAFLD is considered a multisystemic disease and a public health problem
Currently no specific pharmacological treatment is available for NAFLD hence modifications in life style including weight loss by caloric restriction and increased physical activity are still the treatment of choice for this type of patients Recent studies indicate that the supplementation of the diet with omega-3 fatty acids of marine origin eicosapentanoic acid EPAdocosahexaenoic acid DHA and the Mediterranean-style diet rich in omega-3 antioxidants and fiber are efficient for NAFLD treatment because they diminish the intrahepatic fat content and improve the metabolic profile even in non-caloric restriction diets However the socioeconomic and cultural characteristics make the consumption of these food difficult in some populations which has led to the search of alternative vegetal sources rich in these nutrients
Although there is evidence in animal models suggesting that chia Salvia hispanica L could be an alternative able to reduce the intrahepatic fat content its effect on NAFLD has not been studied in humans Hence the objective of this study was to analyze whether the consumption of an isocaloric diet supplemented with 25 gday of chia can diminish NAFLD and the metabolic anomalies that accompany the disease
Currently no specific pharmacological treatment is available for NAFLD hence modifications in life style including weight loss by caloric restriction and increased physical activity are still the treatment of choice for this type of patients Recent studies indicate that the supplementation of the diet with omega-3 fatty acids of marine origin eicosapentanoic acid EPAdocosahexaenoic acid DHA and the Mediterranean-style diet rich in omega-3 antioxidants and fiber are efficient for NAFLD treatment because they diminish the intrahepatic fat content and improve the metabolic profile even in non-caloric restriction diets However the socioeconomic and cultural characteristics make the consumption of these food difficult in some populations which has led to the search of alternative vegetal sources rich in these nutrients
Although there is evidence in animal models suggesting that chia Salvia hispanica L could be an alternative able to reduce the intrahepatic fat content its effect on NAFLD has not been studied in humans Hence the objective of this study was to analyze whether the consumption of an isocaloric diet supplemented with 25 gday of chia can diminish NAFLD and the metabolic anomalies that accompany the disease
Detailed Description:
Participants were chosen from the control group of the Genetics of the Atherosclerotic Disease GEA for its initials in Spanish study performed at the Institute National of Cardiology Ignacio Chávez in Mexico City Mexico The protocol was approved by the Research and Ethics Committee of the Instituto Nacional de Cardiología Ignacio Chavez under the number 16-980 Candidates that accepted to participate in the study signed voluntarily the informed consent
In order to know eating habits and standardize macronutrient dietary composition 24-hour dietary recalls will be applied in the first visit considering two weekdays and one day of the weekend Patients will be instructed to maintain constant their physical activity throughout the study To standardize macronutrient dietary composition an isocaloric diet 55 carbohydrate 30 fat and 15 protein diet will be indicated two weeks before starting chia supplementation After this participants will be instructed to keep up this macronutrient composition during all the intervention period 30 packages of 25 g of chia seeds will be provided to each patient monthly with the instruction to mill one package per day pointing out on the relevance of consume the milled chia accompanied by with water salads cereal or other dishes from breakfast through lunch but always before 600 PM To favor treatment adherence and record adverse events loss appetite loss constipation diarrhea flatulence and nausea allergy or chía chia intolerance patients will be contacted once a week during the intervention Adherence will be determined by counting empty chia packages and evaluation of alpha linolenic acid ALA concentration in plasma which is the chias seeds main fatty acid compound
Anthropometric evaluation laboratory test and computed tomography studies will be made at baseline and after the 8-wk intervention
Nutritional intervention and food intake evaluation In order to know eating habits and standardize macronutrient dietary composition 24-hour dietary recalls will be applied in the first visit considering two weekdays and one day of the weekend Patients will be instructed to maintain constant their physical activity throughout the study To standardize macronutrient dietary composition an isocaloric diet 55 carbohydrate 30 fat and 15 protein diet will be indicated two weeks before starting chia supplementation After this participants will be instructed to keep up this macronutrient composition during all the intervention period 30 packages of 25 g of chia seeds will be provided to each patient monthly with the instruction to mill one package per day pointing out on the relevance of consume the milled chia accompained by with water salads cereal or other dishes from breakfast through lunch but always before 600 PM To favor treatment adherence and record adverse events loss appetite loss constipation diarrhea flatulence and nausea allergy or chía chia intolerance patients will be contacted once a week during the intervention
Adherence will be determined by counting empty chia packages and evaluation of alpha linolenic acid ALA concentration in plasma which is the chias seeds main fatty acid compound Participants wre excluded when the adherence was lower tan 80 according to the package counting or when plasma ALA concentration increased less than 30
Anthropometric evaluation laboratory test and computed tomography studies will be made at baseline and after the 8-wk of diet intervention
Anthropometric evaluation Weight and height will be recorded using a calibrated scale and wall stadiometer with an accuracy of 01 Kg kg and 01 cm after removing excess clothing and shoes The body mass index BMI was calculated as weight kgheight m2 Waist circumference will be measured with a non-stretch tape at the midway between the lowest rib and the iliac crest without clothes around the waist
Laboratory tests After 10-h fasting and 20 min in sitting position venous blood will be collected in assay tubes without anticoagulant and in tubes with K2-EDTA 18 mgmL Glucose total cholesterol triglyceride and high density lipoprotein cholesterol HDL-C concentrations will be determined using direct standard enzymatic colorimetric methods on a COBAS c311 Roche Diagnostics Mannheim Germany Low density lipoprotein cholesterol LDL-C concentration was estimated using the De Long formula The reproducibility and precision of these determinations in our laboratory is assessed by the Center for Disease Control and Prevention Lipids Standardization Program LSP-CDC Atlanta GA USA Plasma free fatty acids FFA will be measured by an enzymatic-colorimetric assay Wako Diagnostics Chuo-Ku Osaka Japan Total fatty acids including ALA will be extracted according to Folch method and analyzed in a Shimadzu GC-8A gas chromatograph equipped with an SP2330 capilar column 25m x 025 mm x 025 Fatty-acid concentrations will be calculated in relation to heptadecanoic acid methyl ester as internal standard fatty acids peaks will be identified by using the Supelco 37 component FAME Mix CRM47885 A plasma control sample will be run in each extraction assay to obtain an ALA inter-assay coefficient variation
Computed tomography study Computed tomography CT is a validated method for measuring visceral adipose tissue VAT and evaluate non alcoholic fatty liver disease In the present study these measurements will be obtained using a 64-slice scanner Somatom Cardiac Sensation 64 Forcheim Bavaria Germany To determine the liver and spleen attenuation index a single slice CT scan is obtained at the level of T11-T12 or T12-L1 Fatty liver is defined as a liverspleen attenuation ratio lower than 10 To calculate the amount of total abdominal tissue TAT and VAT a single slice scan is obtained at the level of L4-L5 the area is expressed in square centimeters cm2 Subcutaneous abdominal tissue SAT was calculated by subtracting the VAT from the TAT area
In order to know eating habits and standardize macronutrient dietary composition 24-hour dietary recalls will be applied in the first visit considering two weekdays and one day of the weekend Patients will be instructed to maintain constant their physical activity throughout the study To standardize macronutrient dietary composition an isocaloric diet 55 carbohydrate 30 fat and 15 protein diet will be indicated two weeks before starting chia supplementation After this participants will be instructed to keep up this macronutrient composition during all the intervention period 30 packages of 25 g of chia seeds will be provided to each patient monthly with the instruction to mill one package per day pointing out on the relevance of consume the milled chia accompanied by with water salads cereal or other dishes from breakfast through lunch but always before 600 PM To favor treatment adherence and record adverse events loss appetite loss constipation diarrhea flatulence and nausea allergy or chía chia intolerance patients will be contacted once a week during the intervention Adherence will be determined by counting empty chia packages and evaluation of alpha linolenic acid ALA concentration in plasma which is the chias seeds main fatty acid compound
Anthropometric evaluation laboratory test and computed tomography studies will be made at baseline and after the 8-wk intervention
Nutritional intervention and food intake evaluation In order to know eating habits and standardize macronutrient dietary composition 24-hour dietary recalls will be applied in the first visit considering two weekdays and one day of the weekend Patients will be instructed to maintain constant their physical activity throughout the study To standardize macronutrient dietary composition an isocaloric diet 55 carbohydrate 30 fat and 15 protein diet will be indicated two weeks before starting chia supplementation After this participants will be instructed to keep up this macronutrient composition during all the intervention period 30 packages of 25 g of chia seeds will be provided to each patient monthly with the instruction to mill one package per day pointing out on the relevance of consume the milled chia accompained by with water salads cereal or other dishes from breakfast through lunch but always before 600 PM To favor treatment adherence and record adverse events loss appetite loss constipation diarrhea flatulence and nausea allergy or chía chia intolerance patients will be contacted once a week during the intervention
Adherence will be determined by counting empty chia packages and evaluation of alpha linolenic acid ALA concentration in plasma which is the chias seeds main fatty acid compound Participants wre excluded when the adherence was lower tan 80 according to the package counting or when plasma ALA concentration increased less than 30
Anthropometric evaluation laboratory test and computed tomography studies will be made at baseline and after the 8-wk of diet intervention
Anthropometric evaluation Weight and height will be recorded using a calibrated scale and wall stadiometer with an accuracy of 01 Kg kg and 01 cm after removing excess clothing and shoes The body mass index BMI was calculated as weight kgheight m2 Waist circumference will be measured with a non-stretch tape at the midway between the lowest rib and the iliac crest without clothes around the waist
Laboratory tests After 10-h fasting and 20 min in sitting position venous blood will be collected in assay tubes without anticoagulant and in tubes with K2-EDTA 18 mgmL Glucose total cholesterol triglyceride and high density lipoprotein cholesterol HDL-C concentrations will be determined using direct standard enzymatic colorimetric methods on a COBAS c311 Roche Diagnostics Mannheim Germany Low density lipoprotein cholesterol LDL-C concentration was estimated using the De Long formula The reproducibility and precision of these determinations in our laboratory is assessed by the Center for Disease Control and Prevention Lipids Standardization Program LSP-CDC Atlanta GA USA Plasma free fatty acids FFA will be measured by an enzymatic-colorimetric assay Wako Diagnostics Chuo-Ku Osaka Japan Total fatty acids including ALA will be extracted according to Folch method and analyzed in a Shimadzu GC-8A gas chromatograph equipped with an SP2330 capilar column 25m x 025 mm x 025 Fatty-acid concentrations will be calculated in relation to heptadecanoic acid methyl ester as internal standard fatty acids peaks will be identified by using the Supelco 37 component FAME Mix CRM47885 A plasma control sample will be run in each extraction assay to obtain an ALA inter-assay coefficient variation
Computed tomography study Computed tomography CT is a validated method for measuring visceral adipose tissue VAT and evaluate non alcoholic fatty liver disease In the present study these measurements will be obtained using a 64-slice scanner Somatom Cardiac Sensation 64 Forcheim Bavaria Germany To determine the liver and spleen attenuation index a single slice CT scan is obtained at the level of T11-T12 or T12-L1 Fatty liver is defined as a liverspleen attenuation ratio lower than 10 To calculate the amount of total abdominal tissue TAT and VAT a single slice scan is obtained at the level of L4-L5 the area is expressed in square centimeters cm2 Subcutaneous abdominal tissue SAT was calculated by subtracting the VAT from the TAT area
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