Effects of Almonds in Glucose-intolerant Adults - a Randomised Controlled Study on Muscle Mass and Obesity, Energy Metabolism and Lipidome, NON-alcoholic Fatty Liver and Inflammation (AGAMEMNON)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- concentration of fasting plasma glucose
研究概览
简要总结
Tree nuts - such as almonds - contribute to beneficial effects of the Mediterranean diet on risk for cardiovascular events, type 2 diabetes, dyslipidemia, hypertension, inflammation and non-alcoholic fatty liver disease. Almonds provide few carbohydrates, but lots of unsaturated fat and dietary fiber. But to which extent and by which mechanisms may almonds improve all aspects of the Metabolic Syndrome? Previous clinical trials showed weaker effects than rodent studies, most possibly due to low statistical power and metabolically insusceptible patients.
The 3-year AGAMEMNON project aims to investigate, if 16 weeks of supplementation with almonds (vs. no treatment) in 150 patients with prediabetes and NAFLD leads to significant improvements in glycemia and liver fat, lipid metabolism, body composition and inflammation. The isocaloric design will outrule effects of weight loss and will allow the analysis of metabolic pathways between fat depots, inflammation, insulin resistance and gut function. Lipidomics are assessed as novel predictor of disease progression and metabolic response.
详细描述
Background / Significance:
T2D affects 5-10 % of the global population, challenging societies, health systems, economy and quality of life. Dietary treatment may avoid disease burdens, save money and protect general health resources, but is often limited to unspecific weight loss recommendations and advise for physical activity. Despite being the common advice, body weight reduction is faced with inconclusive evidence for its impact on long-term risks (obesity paradox?), lack of long-term compliance and irresponsive or ineligible subgroups of patients. The Mediterranean diet provides the ideal dietary composition and reduces CVD risk, improving every axis of the Metabolic Syndrome, including liver fat. It is unclear, though, to which extent tree nuts contribute to this effect.
In meta-analyses, almonds improve glycemia and lipids. Benefits on body composition and inflammation are also expected, these might extend to NAFLD.
n6-PUFAs (typical components of tree nuts) reduce T2D risk and liver fat in humans. This was shown for sunflower oil, but not yet for nuts. Evidence for NAFLD benefits by almonds in humans is limited to observational studies, post-hoc analyses of mixed interventions, and underpowered RCTs.
Aims / Rationale:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
masking not possible; subjects are aware of their allocation after initiation of the intervention
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples
- •NAFLD (MR-S: >5,56 %)
- •BMI between 25 and 40 kg/m²
排除标准
- •Treatment with antidiabetic drugs
- •Overt diabetes mellitus of any kind
- •Severe cardiovascular or pulmonary disorder
- •Renal disorder / Renal insufficiency (eGFR < 60 ml/min/m²)
- •Severe psychiatric disorder (schizophrenia, severe depression; eating disorders)
- •Current or recent (< 5 years) cancer diagnosis
- •Liver disease other than NAFLD
- •Use of corticosteroid treatments
- •Alcohol abuse
- •Ongoing or recently finished (3 months before) weight loss
- •Current participation in other intervention studies
- •Pregnancy
- •Metal implants, claustrophobia
- •Allergy to almonds
结局指标
主要结局
concentration of fasting plasma glucose
时间窗: 16 weeks
change in concentration of fasting plasma glucose
Liver fat content
时间窗: 16 weeks
change in liver fat content (magnetic resonance spectroscopy)
concentration of 2-h plasma glucose (75 g oGTT)
时间窗: 16 weeks
change in concentration of 2-h plasma glucose (75 g oGTT)
次要结局
- serum concentration of IL-6(16 weeks)
- insulin sensitivity (Matsuda)(16 weeks)
- serum concentration of IL-10(16 weeks)
- serum concentration of IL-1ß(16 weeks)
- whole body fat content (kg; measured with BIA)(16 weeks)
- insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion(16 weeks)
- blood pressure (sys/dia)(16 weeks)
- whole body fat content (%; measured with BIA)(16 weeks)
- serum concentration of CRP(16 weeks)
- fasting triglyceride levels(16 weeks)
- serum concentration of IL-18(16 weeks)
- LDL, HDL, LDL/HDL ratio(16 weeks)
- serum concentration of IL-22(16 weeks)
- concentration of serum lipidome parameters (hundreds of lipid species)(16 weeks)
研究者
Stefan Kabisch
Principal investigator
Charite University, Berlin, Germany