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临床试验/NCT05264233
NCT05264233已完成不适用

The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men

University of Reading2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年1月13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
13
试验地点
2
主要终点
Change from baseline in postprandial triacylglycerol

研究概览

简要总结

Current dietary recommendations suggest that lowering intake of saturated fats or replacing it with unsaturated fats will decrease the risk of developing cardiovascular disease. Coconut oil has gained popularity in recent years but it contains 90% saturated fat, which has higher percentage of saturated fat than butter. To date, only limited studies have determined the acute effects of meals containing coconut oil on blood lipids, but findings are inconsistent. Therefore, further studies are needed to address this knowledge gap and compare the postprandial effects of test meals rich in coconut oil with other sources of saturated fatty acids such as butter and unsaturated fatty acids (vegetable oils). A cross-over, double-blind, randomised acute postprandial study will be conducted in 15 healthy men. Participants will be assigned to consume the test meals rich in saturated or unsaturated fatty acids in random order on 3 separate occasions, with 3-4 weeks between each study visit. Participants will be provided with breakfast (toast with jam and milkshake, 50g fat) and lunch (toast with jam and milkshake, 30g fat). The anthropometric, blood pressure, arterial stiffness, and breath samples will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, whole blood culture as well as blood clotting. Breath samples are collected for the measurement of gastric emptying as well as assessment of satiety using questionnaires (100 mm visual analogue scale) completed throughout the day. The findings from this study will contribute to the evidence base on how consuming meals rich in coconut oil influence the level of blood lipids as well as other biomarkers for cardiovascular disease.

研究设计

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

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy men
  • Aged between 30 to 70 years
  • Serum triacylglycerol < 2.3 mmol/l
  • Body mass index between 19-32 kg/m2
  • Total cholesterol < 7.5 mmol/l

排除标准

  • Medical history of myocardial infarction or stroke in the past 12 months
  • Diabetes (defined as fasting glucose > 7.0 mmol/l) or other endocrine disorders
  • Kidney, liver, pancreas or gastrointestinal disorder
  • Hypertension (blood pressure > 140/90 mmHg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation
  • Anaemia (<130 g/L haemoglobin)
  • Taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics)
  • Drinking in excess of 14 units of alcohol per week
  • Planning on a weight-reducing regime
  • Parallel participation in another dietary intervention study
  • Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study

结局指标

主要结局

Change from baseline in postprandial triacylglycerol

时间窗: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes

Triacylglycerol

次要结局

  • Fasting blood lipids(Acute study: taken at 0 (baseline))
  • Change from baseline in postprandial non-esterified fatty acids(Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes)
  • Change from baseline in postprandial insulin(Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes)
  • Change from baseline in postprandial vascular stiffness(Acute study: taken at 0 (baseline), 150, 315, 465 minutes)
  • Change from baseline in postprandial blood pressure(Acute study: taken at 0 (baseline), 180, 300, 480 minutes)
  • Change from baseline in postprandial thrombin generation(Acute study: taken at 0 (baseline), 180, 330, 480 minutes)
  • Change from baseline in postprandial gastric emptying(Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes)
  • Appetite rating(Acute study: taken at 30 minutes intervals after the test meals up to 8 hours)
  • Change from baseline in postprandial gut hormones(Acute study: taken at 0 (baseline), 30, 60, 120, 240, 330, 360, 390 & 480 minutes)
  • Change from baseline in postprandial endothelial activation(Acute study: taken at 0 (baseline),180, 300 and 420 minutes)
  • Change from baseline in postprandial cytokine(Acute study: taken at 0 (baseline),180, 300 and 420 minutes)
  • Weight(Acute study: taken at 0 (baseline))
  • Body composition(Acute study: taken at 0 (baseline))
  • Habitual diet assessment(Prior to the start of the study)

研究者

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

Julie Lovegrove

Director of Hugh Sinclair Unit

University of Reading

研究点 (2)

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