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Chia Supplementation and Non Alcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03942822
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Aida Medina Urrutia, Instituto Nacional de Cardiologia Ignacio Chavez

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 [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.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Modification Dietary Supplement: Milled chia seeds Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Chia Supplemented Diet (Salvia Hispanica) on the Cardiometabolic Risk Profile in Patients With NAFLD (Non Alcoholic Fatty Liver Disease)
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017


Arm Intervention/treatment
Experimental: Chia supplemented group
8 weeks of 25 g/day of milled chia supplemented-isocaloric diet
Dietary Supplement: Milled chia seeds
8 weeks of an isocaloric diet supplemented with 25 g/day of milled chia




Primary Outcome Measures :
  1. Effect of a chia (Salvia hispanica L.) supplemented diet in patients with non-alcoholic fatty liver [ Time Frame: 8 weeks ]
    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

  2. Effect of chia on plasma levels of alpha linolenic acid [ Time Frame: 8 weeks ]
    Increase in Alpha linolenic acid with chia supplemented diet. Measured by gas chromatography.


Secondary Outcome Measures :
  1. Effect of chia on lipid parameters [ Time Frame: 8 weeks ]
    Improvement of lipid parameters (total colesterol, LDL-C, triglycerides, HDL-C) including free fatty acids



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Aida Medina Urrutia, Medical sience investigator, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT03942822    
Other Study ID Numbers: 16-980
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aida Medina Urrutia, Instituto Nacional de Cardiologia Ignacio Chavez:
Non-Alcoholic Fatty Liver Disease
Milled chia seed suplementation
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases