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临床试验/NCT05298111
NCT05298111已完成不适用

Acute Effect of Melon Manis Terengganu Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

Universiti Sultan Zainal Abidin2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年10月1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
36
试验地点
2
主要终点
Blood Glucose Levels

研究概览

简要总结

Open-label, randomised, placebo-controlled, crossover study with two intervention arms. The study was conducted in 30 respondents and the primary objective is to show an improved glycemic response after Melon Manis Terengganu (MMT) peel powder consumption in people at risk of type 2 diabetes.

详细描述

The main aim of the study is to investigate the acute effect of MMT peel powder on glycemic response in people at risk of type 2 diabetes. Besides, the acute effect of MMT peel powder on perceived satiety and energy intake were explored.

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
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Modified Finnish Type 2 Diabetes Risk Assessment Tool (FINDRISC) score ≥ 4
  • Capillary fasting blood glucose (FBG) < 7.0 mmol/L
  • Malaysian
  • Live, work or study in Kuala Nerus, Terengganu
  • Both gender
  • Age 18 to 59 years old
  • Non-smoker
  • Those taking supplement agree to undergo washout period of one week

排除标准

  • Had clinical history of type 2 diabetes mellitus (T2DM)
  • Capillary FBG ≥ 7.0 mmol/L
  • Take oral antidiabetic agents
  • Participate in other weight management programme or interventional research
  • On a prescribed medical diet
  • GI illnesses or conditions
  • Allergy or sensitivity to study products
  • Pregnant, currently breastfeeding, or planning to become pregnant
  • On dietary restrictions

结局指标

主要结局

Blood Glucose Levels

时间窗: Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits

Blood glucose were measured using glucometer (Accu Chek Performa, New South Wales, Australia) from finger-prick blood samples according to the standard operating procedure at baseline (0 min), 30, 60, 90 and 120 minutes.

次要结局

  • Perceived Satiety (Area Under the Curve)(Day 1 and 4 of both study visits)
  • Food Intake(Day 1 and 4 of both study visits)
  • Calories Intake(Day 1 and day 4 of both study visits)

研究者

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

Ong Ying Qian

Principal Investigator

Universiti Sultan Zainal Abidin

研究点 (2)

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