NCT03817099

Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study

Effects of Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP) on Adherence, Acceptability, Efficacy Potential and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ramadan fasting is an important event for Muslims. During Ramadan, all healthy Muslims are asked to abstain from food and drink throughout the day and eat only during daybreak (also know as Sahur in Malay/Arabic language) and after sunset (also know as Iftar in Malay/Arabic language). Patients with type 2 diabetes (T2DM) can be exempted from fasting but most of them do not perceive themselves as sick, and they continue to fast. With so many Muslims with diabetes choosing to fast, there is an immediate need for evidence-based nutrition practice guidelines. This study is conducted to determine the feasibility of implementing the Ramadan Nutrition Plan named My Dia-RNP that is also incorporating diabetes-specific nutrition formula on dietary adherence and acceptability in patients with type 2 diabetes mellitus. We hypothesized that My Dia-RNP is feasible to be practiced by patients with type 2 diabetes.

Detailed description

In Malaysia, average fasting duration is about 14 hours which could potentially cause hypoglycemia, hyperglycemia, ketoacidosis, and dehydration among people with diabetes. Also, Ramadan triggers a prime dietary change leading to increased risk of nutritional issues from improper eating habits and reduction in physical activity level (Hamdy et al., 2016). Ramadan fasting, therefore, represents a challenge to both patients and healthcare professionals (HCPs) including dietitians. Ramadan Nutrition Plan (RNP) has recently published by the International Diabetes Federation (IDF) and the Diabetes and Ramadan (DAR) International Alliance IDF-DAR guidelines. The goal is to provide comprehensive guidance on nutrition practice during Ramadan. However, its feasibility in the real clinical scenarios warrants further investigation. Besides, the use of a diabetes-specific nutrition formula (Nutren Untuk Diabetik®) has been shown beneficial in improving blood glucose control and managing body weight as well as enhancing the nutrient adequacy among people with diabetes (Hamdy and Barakatun-Nisak 2016). While the benefits have been well established, no study has explored its potential during Ramadan. Malaysia Diabetes-Ramadan Nutrition Plan (My Dia-RNP) is proposed to determine the feasibility of implementing the RNP and to incorporate the diabetes-specific nutrition formula (Nutren Untuk Diabetik®) during Ramadan on dietary adherence and acceptability in patients with type 2 diabetes mellitus.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Nutrition Intervention based on My Dia-RNP	Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)
OTHER	Usual Care	Subjects in the group continue with the usual care

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-12-01
• Completion: 2019-12-30
• First posted: 2019-01-25
• Last updated: 2019-08-12

Locations

1 site across 1 country: Malaysia