Effect of a Chia Supplemented Diet (Salvia Hispanica) on the Cardiometabolic Risk Profile in Patients With NAFLD (Non Alcoholic Fatty Liver Disease)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Effect of a chia (Salvia hispanica L.) supplemented diet in patients with non-alcoholic fatty liver
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tomographic diagnosis of NAFLD
- •Insulin resistance (HOMA-IR > 3.7 in women and 3.4 in men)
排除标准
- •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.
结局指标
主要结局
Effect of a chia (Salvia hispanica L.) supplemented diet in patients with non-alcoholic fatty liver
时间窗: 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
Effect of chia on plasma levels of alpha linolenic acid
时间窗: 8 weeks
Increase in Alpha linolenic acid with chia supplemented diet. Measured by gas chromatography.
次要结局
- Effect of chia on lipid parameters(8 weeks)
研究者
Aida Medina Urrutia
Medical sience investigator
Instituto Nacional de Cardiologia Ignacio Chavez