Glucose, High BloodNCT05071950
The Effect of D-allulose on the Glycemic Changes in Patients With Type 2 Diabetes Mellitus During Ramadan Fasting
A study testing D-allulose period in people with Glucose, High Blood, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Glucose, High Blood
- What is being tested?
- D-allulose period
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Mar 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Control period, D-allulose period
- Keywords
- D-allulose, Ramadan fasting, Postprandial glucose, Continuous Glucose Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control periodOther
- 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 periodDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Control period; Dietary Supplement: D-allulose period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 minutes
Secondary outcomes (4)
% TIR
Percentage of time glucose in-target range generated by flash continuous glucose monitoring system
Measured: 180 minutes
% TAR
Percentage of time glucose above-target range generated by flash continuous glucose monitoring system
Measured: 180 minutes
% TBR
Percentage of time glucose below-target range generated by flash continuous glucose monitoring system
Measured: 180 minutes
side-effects of D-allulose
Evaluate the side effects of D-allulose using a questionnaire [multiple choice answers]
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start10 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose, High BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Matsutani Chemical Industry Co., Ltd., Kagawa University
- Responsible party
- Principal investigator, Salimah Binti Japar, Universiti Putra Malaysia
- Investigators
- Salimah Japar, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071950
- Sponsor's protocol ID
- NMRR-19-3457-51288
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35729673
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of D-allulose on the Glycemic Changes in Patients With Type 2 Diabetes Mellitus During Ramadan Fasting
- ClinicalTrials.gov ID
- NCT05071950
- Acronym / sponsor ID
- NMRR-19-3457-51288
- Conditions
- Glucose, High Blood
- Keywords
- D-allulose, Ramadan fasting, Postprandial glucose, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Matsutani Chemical Industry Co., Ltd., Kagawa University
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14 days continuous glucose monitoring | Other | Other: Control period, Dietary Supplement: D-allulose periodThe participants started and completed the control period for continuous 7 days and followed with D-allulose period for 7 days |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | 14 days continuous glucose monitoring |
| 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 | Dietary supplement | 14 days continuous glucose monitoring |
Primary outcome
Postprandial glucose (mg/dl)
Time frame: 180 minutes
* Evaluation on the effect of D-allulose on peak of postprandial glucose * the glucose levels were measured by flash continuous glucose monitoring system
4 secondary outcomes
% TIR
Time frame: 180 minutes
% TAR
Time frame: 180 minutes
% TBR
Time frame: 180 minutes
side-effects of D-allulose
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 35729673Japar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salimah Japar principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-allulose period in people with Glucose, High Blood, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose (mg/dl) (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.