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

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.

Conditions

• Glucose, High Blood

Interventions

OTHER

Control period

* 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

DIETARY_SUPPLEMENT

D-allulose period

* \[started after 7 days of control period\], * 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

Sponsors & Collaborators

• Matsutani Chemical Industry Co., Ltd.

  collaborator UNKNOWN

• Kagawa University

  collaborator OTHER

• Universiti Putra Malaysia

  lead OTHER

Principal Investigators

• Salimah Japar · Universiti Putra Malaysia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-10

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• Malaysia

Study Locations