The Effect of D-allulose on the Glycemic Changes in Patients With Type 2 Diabetes Mellitus During Ramadan Fasting
Condition: Glucose, High Blood
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Control period; D-allulose period
Intervention type(s): Other; Dietary Supplement
Intervention description(s): first 7 days, participants consumed normal meal during iftar (breaking the fast at sunset)
participants did not allow to have added sugar/ sweetness drinks before the iftar meal
flash continuous glucose monitoring system (FreeStyle Libre Pro) was used to measure the glucose
food diary was used to record the iftar meal; [started after 7 days of control period],
participants continued with D-allulose period for 7 days continuously
participants consumed 8.5 g of D-allulose, (dissolve in plain water normal) before start the iftar meal
participants did not allow to have added sugar/ sweetness drinks before the iftar meal
flash continuous glucose monitoring system (FreeStyle Libre Pro) was used to measure the glucose
food diary was used to record the iftar meal
a questionnaire (multiple choice anwers) was used to record the side effects of D-allulose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: D-allulose; Ramadan fasting; Postprandial glucose; Continuous Glucose Monitoring