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临床试验/NCT04748575
NCT04748575已完成不适用

Effect of Acute Acai Berry Supplementation on Post-prandial Glycaemia in Healthy Adults: a Randomised Controlled Study

St Mary's University College2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年11月5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
10
试验地点
2
主要终点
Blood glucose

研究概览

简要总结

Type 2 Diabetes Mellitus is a chronic disease that results in hyperglycaemia. This study aimed to identify whether the anthocyanins contained in acai berries can mitigate postprandial glycaemia in healthy adults when consumed in conjunction with carbohydrate. Study design was double blind randomised crossover with glycaemic levels assessed via capillary blood samples taken at baseline and over a 2 hour post-prandial period.

详细描述

Type 2 Diabetes Mellitus (T2DM) is a group of chronic metabolic disorders, characterised by insulin resistance and relative insulin deficiency, that results in hyperglycaemia. In the UK an estimated 4.3m people live with T2DM, and it is a major cause of kidney failure, heart attacks, stroke, blindness and lower limb amputation. The primary digestive enzymes that affect carbohydrate digestion and hence postprandial glycaemic levels have been identified as α-amylase and α-glucosidase. Inhibition of these enzymes therefore reduces the rate of glucose absorption and is the principle behind T2DM medications such as acarbose, miglitol and voglibose. Whilst acai berries have been found to be rich in α-amylase and α-glucosidase, no research has been conducted on healthy adults to ascertain whether the consumption of acai berries in conjunction with carbohydrate mitigates the rise in postprandial glycaemia.

10 participants were recruited for a double blind randomised crossover study where participants consumed smoothies containing either acai or placebo after 10 hours of fasting. Capillary blood samples were taken at baseline then at 30 minutes intervals until 2 hours after consumption. The study included data for sex (female/male), age (years), weight (kg), height (cm), body mass index (kg/m2) and blood glucose (mmol/l). All data collection, smoothies preparation, smoothies consumption and blood sampling procedures were completed at St Mary's University during the period November-December 2020. Statistical analysis was conducted on the data for postprandial glycaemic response to ascertain whether the consumption of acai mitigated the glycaemic response relative to the placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Smoothies were prepared by the Laboratory Technician and blinded from the participant and investigator. Acai and placebo smoothies were matched nutritionally including for carbohydrate, total sugars, protein, fat and fibre. Additionally, the smoothies were matched for colour, taste and temperature and were served in opaque containers.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI of 18.5 - 24.9 kg/m2.

排除标准

  • Known allergy to acai/berries or lactose.
  • Pregnant or lactating.
  • Alcohol/drug dependency.
  • Currently on an energy-restriction diet or have had a body weight change >10% in last 2 months.
  • Eating disorders.
  • Diagnosed with diabetes or another chronic condition.
  • Taking chronic medication.
  • Allergy to any of materials used in, or an unsurmountable fear of, the finger-prick procedure.

结局指标

主要结局

Blood glucose

时间窗: Baseline to 120 minutes after intervention.

Finger capillary sample collected by micro cuvette (Glucose 201, HemoCue, UK) and analysed electronically (HemoCue 201+, HemoCue,UK).

次要结局

未报告次要终点

研究者

发起方
St Mary's University College
申办方类型
Other
责任方
Sponsor

研究点 (2)

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