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

NCT ID: NCT05071950

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2021-06-30

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.

Conditions

Glucose, High Blood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

14 days continuous glucose monitoring

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

Group Type: OTHER

Control period

Intervention Type: 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

D-allulose period

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matsutani Chemical Industry Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Kagawa University

OTHER

Sponsor Role: collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Salimah Binti Japar

RN, MPhil

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salimah Japar

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Locations

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 35729673 (View on PubMed)

Other Identifiers

NMRR-19-3457-51288

Identifier Type: -

Identifier Source: org_study_id