Clinical trial NCT05071950: The Effect of D-allulose on the Glycemic Changes in Patients With Type 2 Diabetes Mellitus During Ramadan Fasting
Official title: The Effect of D-allulose on the Glycemic Changes in Patients With Type 2 Diabetes Mellitus During Ramadan Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, High Blood
Keywords: D-allulose
Ramadan fasting
Postprandial glucose
Continuous Glucose Monitoring
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Matsutani Chemical Industry Co., Ltd.
name: Kagawa University
First posted: 2021-10-08
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postprandial glucose (mg/dl)
timeFrame: 180 minutes
Secondary outcomes:
measure: % TIR
timeFrame: 180 minutes
measure: % TAR
timeFrame: 180 minutes
measure: % TBR
timeFrame: 180 minutes
measure: side-effects of D-allulose
timeFrame: 24 hours
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Salimah Japar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Japar S, Fukunaga K, Kobayashi T, Imachi H, Sato S, Saheki T, Ibata T, Yoshimura T, Soh KL, Ong SL, Muhamed Z, Murao K. A pilot study on the effect of D-allulose on postprandial glucose levels in patients with type 2 diabetes mellitus during Ramadan fasting. Diabetol Metab Syndr. 2022 Jun 21;14(1):86. doi: 10.1186/s13098-022-00856-3.