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

NCT05071950 | Completed

• 1 other identifier: NMRR-19-3457-51288
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose, High Blood

Keywords

D-allulose; Ramadan fasting; Postprandial glucose; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose (mg/dl)

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

  180 minutes

Secondary Outcomes (4)

• % TIR

  180 minutes

• % TAR

  180 minutes

• % TBR

  180 minutes

• side-effects of D-allulose

  24 hours

Study Arms (1)

14 days continuous glucose monitoring

OTHER

The participants started and completed the control period for continuous 7 days and followed with D-allulose period for 7 days

Other: Control period; Dietary Supplement: D-allulose period

Interventions

Control period OTHER

* 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

14 days continuous glucose monitoring

D-allulose period DIETARY_SUPPLEMENT

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

14 days continuous glucose monitoring

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Matsutani Chemical Industry Co., Ltd.: collaborator
• Kagawa University: collaborator

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 35729673 DERIVED

Study Officials

• Salimah Japar

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MPhil

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 8, 2021
• Study Start: March 10, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)