Rice Intervention in Chronic Health Study
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT06560541
- Lead Sponsor
- Taylor's University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Diabetes Arm:<br><br>Inclusion Criteria:<br><br> - Attending outpatient clinics<br><br> - Age 18 - 60 years (i.e. adult population)<br><br> - Both male and female<br><br> - Regular consumption of polished white rice (presumably high-GI) = 200g/day<br><br> - Established T2DM patients on oral medication<br><br> - Glycated hemoglobin (HbA1c) 7% to 10%<br><br> - Willing to take part and being compliant to the study protocol<br><br>Exclusion Criteria:<br><br> - Glycated hemoglobin (HbA1c) <7% or >10%<br><br> - Use of insulin<br><br> - A change in the type of treatment (e.g. insulin injection) during the intervention<br> period<br><br> - Regular consumption of low-GI rice types (basmati) or colored rice (red rice, purple<br> rice, black rice) for =3 months.<br><br> - Oral corticosteroids > 3 months<br><br> - Pregnancy<br><br> - Unstable medical condition.<br><br> - Undergone any major operation in the past 3 months<br><br> - Chronic alcohol drinker.<br><br> - Not on weight loss diets or supplementation.<br><br> - Taking part in another clinical trial.<br><br>Healthy arm:<br><br>Inclusion Criteria:<br><br> - Healthy free living<br><br> - With glycated haemoglobin (HbA1c <6.3%)<br><br> - Age 18 - 60 years (i.e. adult population)<br><br> - Both male and female<br><br> - Regular consumption of polished white rice (presumably high-GI) = 200g/day<br><br> - Generally, physically and mentally healthy as per medical examination.<br><br> - Willing to take part and being compliant to the study protocol.<br><br>Exclusion Criteria:<br><br> - Regular consumption of low-GI rice types (basmati) or colored rice (red rice, purple<br> rice, black rice) for =3 months<br><br> - Presence of gastrointestinal disease, metabolic diseases such as diabetes, kidney<br> failure, liver or pancreatic disease, hyperthyroidism, cancer or severe<br> malnutrition.<br><br> - Oral corticosteroids > 3 months<br><br> - Pregnancy<br><br> - Undergone any major operation in the past 3 months<br><br> - Chronic alcohol drinker.<br><br> - Not on weight loss diets or supplementation..<br><br> - Taking part in another clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in cardio-metabolic parameters;Changes in urinary and plasma metabolome;Changes in mitochondrial DNA methylation and circulating miRNAs expression
- Secondary Outcome Measures
Name Time Method Consumer Acceptance Test;Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food;Dietary Pattern of Malaysian Adults with and without diabetes;Diet Quality of Malaysian Adults with and without diabetes;Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics).