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

August 9, 2019 updated by: Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Recruiting
        • Universiti Putra Malaysia
        • Contact:
          • Barakatun-Nisak Mohd Yusof, PhD
          • Phone Number: 2524 03-89472524
          • Email: bnisak@upm.edu.my
        • Contact:
          • Barakatun-Nisak Mohd Yusof, PhD
          • Phone Number: 2524 0389472524
          • Email: bnisak@upm.edu.my

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Muslim patients aged > 18 years old
  • Have a confirmed diagnosis of T2D for at least 6 months
  • BMI > 18.5 but < 40 kg/m2
  • HbA1c of > 6.5% but < 10%
  • On a stabilised dose of oral anti-diabetes agents (OAD) for the past 2 months prior to the study
  • Willing to fast for at least 15 days during Ramadan

Exclusion Criteria:

  • History of hypoglycaemia leading to hospitalization during the previous Ramadan
  • Liver disease
  • Abnormal liver function test or renal profiles
  • On insulin injection
  • Reported abnormal thyroid stimulating hormones
  • Use of medications known to effect lipid or glucose metabolism such as steroid
  • Pregnancy or the desire to become pregnant in the next 3 months
  • On any weight loss program or weight loss medications
  • History of cancer undergoing active treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: My Dia-RNP
In the My Dia-RNP group, participants will undergo the pre-RNP assessment 2 weeks before Ramadan. They will be given a nutrition education based on the Ramadan Nutrition Plan Guide published by IDF-DAR Practical Guidelines. They will also be asked to incorporate diabetes-specific nutrition formula (Nutren untuk Diabetik®) within the prescribed calories before Ramadan period to help them familiarise with a dietary change.
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)
Active Comparator: Usual Care
Participant in this group will continue in a usual care (UC) group. They will receive dietary advice based on the Practical Guide to Diabetes Management in Ramadan produced by Ministry of Health (2015).
Other: Usual Care
Subjects in the group continue with the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants completed the study
Time Frame: 12 weeks
The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants adhered to the intervention
Time Frame: 12 weeks
Dietary adherence refers to the ability of the participants to adhere to the selected group. This study aims to achieve the completeness of Ramadan Diaries and the able to consume diabetes-specific nutrition formula (Nutren® untuk Diabetik) for at least 75% during the study period.
12 weeks
Efficacy potential on the rate of hypoglycemia
Time Frame: 12 weeks
Changes in rate of hypoglycemia during Ramadan
12 weeks
Efficacy potential on the fructosamine level
Time Frame: 4 weeks
Changes in fructosamine levels
4 weeks
Efficacy potential on fasting glucose
Time Frame: 12 weeks
Changes in fasting blood glucose levels
12 weeks
Efficacy potential on glycemic control
Time Frame: 12 weeks
Changes in HbA1c levels
12 weeks
Efficacy potential on functional status
Time Frame: 12 weeks
Changes in hand grip strength
12 weeks
Efficacy potential on body mass index
Time Frame: 12 weeks
Changes in body mass index
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

Joslin Diabetes Center
Nestle Health Science

Investigators

  • Principal Investigator: Barakatun-Nisak Mohd Yusof, PhD, Universiti Putra Malaysia
  • Principal Investigator: Wan Zul Haikal Hafiz Wan Zukiman, Mmed, Universiti Putra Malaysia
  • Principal Investigator: Noraida Omar, PhD, Universiti Putra Malaysia
  • Principal Investigator: Zalina Abu Zaid, PhD, Universiti Putra Malaysia
  • Principal Investigator: Azrina Azlan, PhD, Universiti Putra Malaysia
  • Principal Investigator: Firdaus Mamat @ Mukhtar, PhD, Universiti Putra Malaysia
  • Principal Investigator: Norhasmah Sulaiman, PhD, Universiti Putra Malaysia
  • Principal Investigator: Siti NurA'syura Adznam, PhD, Universiti Putra Malaysia
  • Principal Investigator: Nur Maziah Hanum Osman, Master, Universiti Putra Malaysia
  • Principal Investigator: Nor Farahain Yahya, Degree, Universiti Putra Malaysia
  • Principal Investigator: Osama Hamdy, MD, PhD, Joslin Diabetes Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyDia-RNP study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data is subjected to privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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