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)
Verified date | May 2019 |
Source | Instituto Nacional de Cardiologia Ignacio Chavez |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 1, 2017 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Tomographic diagnosis of NAFLD - Insulin resistance (HOMA-IR > 3.7 in women and 3.4 in men) Exclusion Criteria: - Previous diabetes diagnosis - Use of hypoglycemic or hypolipidemic medications - Significant weight changes during the previous 3 months (± 5% of their habitual weight) - Consumption of vitamins, herbal or food supplements - Gastrointestinal, renal, or hepatic diseases - Eating, psychiatric or cognitive disorders that would hinder them of understanding and complying with the instructions of the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cardiologia Ignacio Chavez |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of a chia (Salvia hispanica L.) supplemented diet in patients with non-alcoholic fatty liver | To assess the effect of 25 g/day of milled chia in 25 patients with NAFLD.Improvement of LSAI (liver spleen attenuation index) measured by computed tomography In a single-arm experimental design study | 8 weeks | |
Primary | Effect of chia on plasma levels of alpha linolenic acid | Increase in Alpha linolenic acid with chia supplemented diet. Measured by gas chromatography. | 8 weeks | |
Secondary | Effect of chia on lipid parameters | Improvement of lipid parameters (total colesterol, LDL-C, triglycerides, HDL-C) including free fatty acids | 8 weeks |
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