NCT06377631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 Postmenopausal Women With Abdominal Obesity
Fundació Eurecat4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月7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
- 50
- 试验地点
- 4
- 主要终点
- Change in Visceral Adiposity
研究概览
简要总结
This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity.
详细描述
In postmenopausal women, the risk of non-alcoholic fatty liver disease (NAFLD) increases due to hormonal changes and metabolic shifts. Menopause leads to a decline in estrogen levels, affecting lipid metabolism and promoting abdominal and visceral fat accumulation. This visceral adiposity poses a significant risk factor for insulin resistance, type 2 diabetes, dyslipidemia, cardiovascular diseases, and NAFLD. While the prevalence of NAFLD is initially higher in men, it becomes comparable or even higher in postmenopausal women due to these metabolic changes.
Studies suggest that estrogen deficiency post-menopause contributes to the development of NAFLD in women. Lower serum estrogen levels are associated with a higher likelihood of NAFLD development, indicating the potential role of hormone replacement therapy (HRT) in mitigating NAFLD risk in postmenopausal women. However, the use of HRT must be carefully evaluated due to potential adverse effects on cardiovascular health.
Thus, novel, effective and safety therapeutic strategies for managing metabolic disorders in postmenopausal women are highly desirable.
The main objective of this study is to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat in postmenopausal women with abdominal obesity.
The secondary objectives of this study are to evaluate the effect of daily intake of the multi-ingredient aforementioned in liver function markers, anthropometric parameters, blood pressure and heart rate, markers of lipid metabolism, markers of glucidic metabolism, inflammatory markers, histidine serum levels, sexual hormones, the temperature of supraclavicular brown adipose tissue, changes in the intestinal microbiota, changes in the expression of lipid metabolism-related genes and symptoms associated with postmenopause.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women aged 50 to 65 years.
- •BMI ≥27.5 kg/m^2 and ≤32.5 kg/m^
- •Waist circumference ≥88 cm.
- •No hormone replacement therapy.
- •Read, write and speak Catalan or Spanish.
- •Sign the informed consent.
排除标准
- •Present values of body mass index < 27.5 kg/m^2 or > 32.5 kg/m^2
- •Present values of waist circumference > 115 cm.
- •Present diabetes.
- •Present dyslipidemia.
- •Present anemia.
- •Taking supplements, multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
- •Consume 2 or more Standard Beverage Units (SBU) daily or 17 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
- Change in Hip circumference (cm)(Change from Baseline hip 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))
- Ethnicity(At day -7 (pre-selection visit))
- 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 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 Arm circumference (cm)(Change from Baseline Arm 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 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 triglycerides (TG, mg/dL)(Change from Baseline serum triglycerides at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Body Weight (kg)(Change from Baseline Weight at 6 and 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 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))
- Height (cm)(At baseline)
- Age(At day -7 (pre-selection visit))
- 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 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 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 Waist-to-Hip ratio(Change from Baseline Waist-to-Hip ratio at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in Lipid Accumulation Product (LAP)(Change from Baseline Lipid Accumulation Product ratio 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 heart rate (bpm)(Change from Baseline Heart rate at 6 and 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 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 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 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 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 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 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 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 lipidomic profile(Change from Baseline Lipidomic profile at 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 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 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 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 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 Acylcarnitine levels in blood (umol/L)(Change from Baseline Acylcarnitine levels at 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in 17-beta-estradiol (E2) levels in blood (pg/mL)(Change from Baseline 17-beta-estradiol (E2) levels 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))
- Concomitant medication(At day -7 (pre-selection visit), day 1 (visit V1), day 43 (visit 2) and day 85 (visit 3))
- Change in the Supraclavicular skin temperature(Change from Baseline Supraclavicular skin temperature at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo))
- Change in postmenopausal symptoms(Change from Baseline postmenopausal symptoms at 6 and 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 Follicle-stimulating hormone (FSH) levels in blood (mU/mL)(Change from Baseline FSH levels 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 the expression of lipid-metabolism genes in PBMC(Change from Baseline gene expression 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))
- Consumption of dietary supplements(At day -7 (pre-selection visit), day 1 (visit V1), day 43 (visit 2) and day 85 (visit 3))
- Adverse events(At 6 weeks (V2) and at 12 weeks (V3) for each of the two treatments (multi-ingredient and placebo))
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