NCT03942822

Chia Supplementation and Non Alcoholic Fatty Liver Disease

Completed NA Last updated 8 May 2019

What this trial tests

NA trial testing Milled chia seeds in Non-Alcoholic Fatty Liver Disease in 40 participants. Completed in 1 September 2017.

Timeline

1 September 2016

Primary endpoint
1 September 2017

1 September 2017

Quick facts

Lead sponsor	Instituto Nacional de Cardiologia Ignacio Chavez
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 September 2016
Primary completion	1 September 2017
Estimated completion	1 September 2017

Drugs / interventions tested

• Milled chia seeds

Conditions studied

• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →
• Dietary Modification — all drugs for Dietary Modification →

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez — full company profile →

Who can join

Adults 30 to 70, any sex, with Non-Alcoholic Fatty Liver Disease or Dietary Modification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chia (Salvia hispanica)-supplemented diet ameliorates non-alcoholic fatty liver disease and its metabolic abnormalities in humans.
   Medina-Urrutia A, Lopez-Uribe AR, El Hafidi M, González-Salazar MDC, et al · · 2020 · cited 22× · PMID 32430018 · DOI 10.1186/s12944-020-01283-x
2. NAFLD and NAFLD Related HCC: Emerging Treatments and Clinical Trials.
   Khare T, Liu K, Chilambe LO, Khare S. · · 2025 · cited 12× · PMID 39796162 · DOI 10.3390/ijms26010306
3. Addressing the heterogeneity in liver diseases using biological networks.
   Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002
4. Exploring the Therapeutic Potential of <i>Artemisia</i> and <i>Salvia</i> Genera in Cancer, Diabetes, and Cardiovascular Diseases: A Short Review of Clinical Evidence.
   Tavares WR, Seca AML, Barreto MC. · · 2025 · cited 3× · PMID 39941696 · DOI 10.3390/jcm14031028