Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Effect of a Chia Supplemented Diet (Salvia Hispanica) on the Cardiometabolic Risk Profile in Patients With NAFLD (Non Alcoholic Fatty Liver Disease)
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
[EPA]/docosahexaenoic 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 g/day of chia can diminish NAFLD and
the metabolic anomalies that accompany the disease.
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 6:00 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 chia`s 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 6:00 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 chia`s 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 0.1 Kg kg and 0.1 cm, after removing excess clothing
and shoes. The body mass index (BMI) was calculated as weight (kg)/height (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 (1.8 mg/mL).
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 0.25 mm x 0.25). 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 liver/spleen attenuation ratio lower than 1.0. 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.
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