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临床试验/NCT05071950
NCT05071950已完成不适用

The Effect of D-allulose on the Glycemic Changes in Patients With Type 2 Diabetes Mellitus During Ramadan Fasting

Universiti Putra Malaysia2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年3月10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
21
试验地点
2
主要终点
Postprandial glucose (mg/dl)

研究概览

简要总结

Postprandial hyperglycemia or rapid rise in blood glucose is defined as a blood glucose level>7.8 mmol/L (140 mg/dL) 1- 2 hours after consumption of food. It is associated to the development of diabetes among healthy individuals and a risk factor for the onset and progression of microvascular and macrovascular complications among diabetic patients. In Ramadan, postprandial hyperglycemia is often observed after the iftar (fasting break after sunset). The frequency of eating normally decreases during Ramadan, however, the energy intake remains questionable because dietary practices during Ramadan are influenced by local culture, economic status and individual dietary behaviors. In many Muslim societies including Malaysia, Ramadan has known as a month of feasting. Iftar meals are typically high calorie, carbohydrate-rich and usually sweet food resulting in rapid rise in glucose after the meal. This poses a challenge for the people with diabetes to manage their glucose level. D-allulose (a C-3 epimer of D-fructose) is a rare sugar and reported to have several health benefits, such as suppressing a rise in postprandial glucose levels. There is still a scarcity of research on patients with diabetes. As a result, the current clinical study sought to investigate the effect of supplemental D-allulose on participants with type 2 diabetes who consume real-meal calories during Ramadan iftar.

详细描述

D-allulose (a C-3 epimer of D-fructose) is one of the rare sugar types with zero calories, has 70 % sweetness as sucrose, and occur in a small quantities in nature. Extensive basic and clinical studies have reported beneficial outcomes to human health, includes improve hypoglycemia, reduced postprandial hyperglycemia, hypolipidemia, and antioxidant. D-allulose can be taken up to 0.5 g/kg daily will no side-effect on the human body. The U.S. Food and Drug Administration (FDA) has declared that D-allulose is Generally Recognized As Safe (GRAS) for use as a food ingredient and with other sweeteners. Previous clinical studies on D-allulose had shown an effective glucose suppressive effect after the meal, mostly in healthy individuals and pre-diabetics. There is still a scarcity of research on patients with diabetes. As a result, the current clinical study sought to investigate the effect of supplemental D-allulose on participants with type 2 diabetes who consume real-meal calories during Ramadan iftar (breaking fast at sunset). This was a non-randomized intervention study, which involved a single-arm group, and conducted during Muslim fasting month (Ramadan) between 13 April to 12 May 2021. The protocol required continuous 14 days of Ramadan and it was divided into two consecutive periods; began with first 7-day of control period and followed with a consecutive 7-day of D-allulose period. At the D-allulose period, 8.5g of D-allulose was consumed before the iftar meal. The FreeStyle Libre Pro Flash Glucose Monitory system (CFGM) was used to measure the glucose values.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Type 2 diabetes (Group 4 -low-risk group as defined by International Diabetes Federation ) - low-risk group is defined as a well-controlled diabetic patient treated with lifestyle modification and oral anti-diabetic medications
  • The patient was diagnosed with type 2 diabetes before the previous Ramadan. They also had fasted during previous year of Ramadan (2020) and are planning to fast during the coming Ramadan (2021)

排除标准

  • Patients with poor glycemic control; HbA1c of 8% or more
  • Patients with other serious complications
  • Pregnant, maternal, breastfeeding or pregnant women
  • Patients with severe renal dysfunction (serum creatinine level of 1.5 mg/dl or higher)
  • Patients who advised not to fast by doctor
  • Patients participating in other clinical trials
  • Patients with contraindications to D-allulose

结局指标

主要结局

Postprandial glucose (mg/dl)

时间窗: 180 minutes

* Evaluation on the effect of D-allulose on peak of postprandial glucose * the glucose levels were measured by flash continuous glucose monitoring system

次要结局

  • side-effects of D-allulose(24 hours)
  • % TAR(180 minutes)
  • % TBR(180 minutes)
  • % TIR(180 minutes)

研究者

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

Salimah Binti Japar

RN, MPhil

Universiti Putra Malaysia

研究点 (2)

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