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临床试验/NCT06270901
NCT06270901已完成不适用

Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolic Response in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases

University of Bonn2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Parameters of lipid metabolism in blood

研究概览

简要总结

The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated.

详细描述

In a randomized crossover design, 30 older men and women with increased risk for cardiometabolic diseases consume 4 mixed meals, which differ in dietary pattern, protein source and protein quantity. Two meals are designed according to the Planetary Health Diet with legumes as primary protein source whereas the other two meals are designed according to the Western Diet with animal food as primary protein source. Two meals are designed as high protein meals (62 g of protein) and two meals are designed as low protein meals (36 g of Protein). Therefore, participants consume 4 different test meals, a Low and a High Protein Western Diet Meal and a Low and a High Protein Planetary Health Diet Meal in a randomized order. During a postprandial observation period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6) and vascular function (e.g., pulse wave velocity) are analysed. Furthermore, amino acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., Ghrelin) are investigated. Each intervention will be separated by a washout period of approximately 14 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent
  • Non-smoking
  • BMI: 27 - 34,9 kg/m2
  • Waist circumference (women ≥ 80 cm, men ≥ 94 cm)
  • Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg
  • At least one of the following criteria
  • Fasting triglycerides in serum: ≥ 150 mg/dL
  • Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dL
  • Fasting C-reactive protein in serum: ≥ 2 mg/L
  • Fasting glucose in plasma: ≥ 100 mg/dL

排除标准

  • food intolerances and allergies (especially to legumes)
  • malabsorption syndromes
  • thyroid diseases
  • impaired renal function
  • chronic liver disease
  • heart failure
  • myocardial infarction
  • insulin-dependent diabetes mellitus
  • chronic inflammatory diseases
  • immunosuppression
  • intake of supplements (e.g., fish oil)
  • Participation in another study
  • other exclusion criteria at the discretion of the physician/ investigator

结局指标

主要结局

Parameters of lipid metabolism in blood

时间窗: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Triglycerides (mg/dL)

次要结局

  • Parameters of endothelial function in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
  • Blood urea(Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours))
  • Endothelial function(Postprandial period of 6 hours (T=0, 2, 4, 6 hours))
  • Parameters of hunger and satiety in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
  • Blood amino acid profile(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
  • Uric acid in blood(Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours))
  • Parameters of inflammation in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
  • Neuropsychological parameters(Postprandial period of 6 hours (T=0.5, 3, 6 hours))
  • Parameters of lipid metabolism in blood(Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours))
  • Parameters of glucose metabolism in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Sarah Egert

Sarah Egert, Prof PhD

University of Bonn

研究点 (2)

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