NCT05807204已完成不适用
Effect of a Multi-ingredient of L-Histidine, L-Serine, L-Carnosine and N-Acetylcysteine on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity. Randomized, Parallel, Placebo Controlled, Triple Blind Study.
Fundació Eurecat2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Visceral Adiposity
研究概览
简要总结
The aim of this study is to validate the efficacy of specific combination of different natural histidine-related amino acids in the reduction of visceral fat and liver steatosis, as well their associated comorbidities, in individuals with abdominal obesity.
详细描述
World Health Organization (WHO) defines obesity as an excess of fat accumulation in adipose tissues and in other metabolic organs, leading to serious health implications. Obesity is a rising issue whose prevalence has defined as a global pandemic or globesity (>30% world population) being responsible of millions of deaths annually. Also, obesity is related with several comorbidities such as non-alcoholic fatty liver disease (NAFLD), with a global prevalence of >25%. Thus, strategies to ameliorate obesity and NAFLD are critical to improve life expectancy and quality of life and to reduce the economic burden of both diseases.
Current therapies against obesity are mainly focused on weight loss, including lifestyle intervention, to modify eating behaviours and to promote physical activity. However, the compliance of patients with these therapies is small. In addition, there are some drugs to fight against these diseases. In obesity, these medical therapies are focused to decrease fat gastrointestinal absorption using lipase inhibitors with several side effects: faecal incontinence, abdominal cramping and raise in blood pressure. In NAFLD, medical therapies are designed to reduce insulin resistance, using pioglitazone and metformin. However, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) recommend avoiding pioglitazone use by its relationship with heart failure and cancer, and metformin provides just a modest improvement in NAFLD.
Thus, the finding of new and efficient therapeutic agents is highly desirable to combat these global diseases.
The main objective of this study is to evaluate the effect of daily intake of a specific combination of L-histidine, L-serine, L-carnosine and N-Acetylcysteine, in combination with dietary recommendations, on the amount of visceral fat in individuals with abdominal obesity.
The secondary objectives of this study are to evaluate the effect of daily intake of the multi-ingredient aforementioned in liver fat content and obesity related comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men older than 40 years.
- •BMI ≥30.0 kg/m^2 and ≤35.0 kg/m^2
- •Waist circumference ≥102 cm.
- •Read, write and speak Catalan or Spanish.
- •Sign the informed consent.
排除标准
- •Present values of body mass index > 35 kg/m^2
- •Present values of waist circumference > 150 cm.
- •Present diabetes.
- •Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
- •Present anemia.
- •Taking supplements, multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
- •Consume 4 or more Standard Beverage Units (SBU) daily or 28 SBU weekly.
- •Be a smoker.
- •Present any diagnosed liver disease other than NAFLD.
- •Have lost more than 3 kg of weight in the last 3 months.
- •Present food intolerances and/or allergies related to the study products, such as hypersensitivity to maltodextrin or N-Acetylcysteine.
- •Presenting any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases.
- •Follow a pharmacological treatment with immunosuppressants, cytotoxic agents, corticosteroids or other drugs that could cause hepatic steatosis or alter the measurements in the liver.
- •Being participating or having participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
- •Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
- •Suffering from eating behavior disorders or psychiatric disorders.
- •Being unable to follow study guidelines.
结局指标
主要结局
Change in Visceral Adiposity
时间窗: Change from Baseline Visceral Adiposity at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Visceral fat content measured using a dual energy x-ray absorptiometry (DXA) scanner
次要结局
- Height (cm)(At Baseline)
- Change in Weight (kg)(Change from Baseline Weight at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Waist circumference (cm)(Change from Baseline Waist circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum glucose levels (mg/dL)(Change from Baseline serum glucose levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Body Mass Index (BMI) (Kg/m^2)(Change from Baseline Body Mass Index at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Hepatic Steatosis(Change from Baseline Hepatic Steatosis at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Arm circumference (cm)(Change from Baseline Arm circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)(Change from Baseline biomarkers of oxidative stress at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum total cholesterol (mg/dL)(Change from Baseline serum total cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Dietary habits(Change from Baseline Dietary habits at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in concomitant medication(Change from Baseline concomitant medication at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in the consumption of food supplements(Change from Baseline consumption of food supplements at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Neck circumference (cm)(Change from Baseline Neck circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Conicity Index(Change from Baseline Conicity Index at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Systolic Blood Pressure (mm Hg)(Change from Baseline Systolic Blood Pressure at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Diastolic Blood Pressure (mm Hg)(Change from Baseline Systolic Blood Pressure at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in intestinal microbiota composition(Change from Baseline intestinal microbiota composition at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL)(Change from Baseline serum high-density lipoprotein cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum triglycerides (TG, mg/dL)(Change from Baseline serum triglycerides at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum aspartate aminotransferase (AST, U/L)(Change from Baseline serum aspartate aminotransferase at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum leptin levels (pg/mL)(Change from Baseline serum leptin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL)(Change from Baseline serum low-density lipoprotein cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum alanine aminotransferase (ALT, U/L)(Change from Baseline serum alanine aminotransferase at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum gamma glutamyl transferase (GGT, U/L)(Change from Baseline serum gamma glutamyl transferase at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum insulin levels (mU/L)(Change from Baseline serum insulin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Adiponectin/Leptin ratio (numerical ratio)(Change from Baseline Adiponectin/Leptin ratio at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL)(Change from Baseline serum MCP-1 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL)(Change from Baseline plasma TNF-alpha levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum adiponectin levels (ng/mL)(Change from Baseline serum adiponectin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in plasma Interleukin 10 (IL-10) levels (pg/mL)(Change from Baseline plasma IL-10 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in plasma Interleukin 6 (IL-6) levels (pg/mL)(Change from Baseline plasma IL-6 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL)(Change from Baseline plasma CD14 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)(Change from Baseline HOMA-IR at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Triglyceride glucose index (TyG)(Change from Baseline TyG at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL)(Change from Baseline plasma ICAM-1 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L)(Change from Baseline plasma LDLox levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Histidine levels in blood (umol/L)(Change from Baseline Histidine levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in serum C-Reactive protein levels (mg/L)(Change from Baseline serum C-Reactive protein levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Fatty Liver Index (FLI)(Change from Baseline FLI at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Plasma atherogenic index(Change from Baseline Plasma atherogenic index at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Physical activity(Change from Baseline Physical activity at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change of Food Intake Biomarkers(Change from Baseline Food Intake Biomarkers at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Adverse events(After 6 (V2) and 12 weeks (V3) of treatment period for each of the two treatments (multi-ingredient and placebo))
- Analysis of genetic polymorphisms(Single nucleotide polymorphisms (SNPs) in loci of genetic susceptibility to abdominal adiposity will be studied at 12 weeks after treatment for each of the two treatments (multi-ingredient and placebo))
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研究点 (2)
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