An Intervention Study on the Effect of Brazilian Spinach Supplementation on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Brazilian spinach supplementation effective in improving the nutritional status of Type 2 Diabetes Mellitus patient.

Detailed Description
-----------------
Background: Vegetables are valuable health promotion foods because they contain vital nutrients such as vitamins, minerals, proteins, fibres and bio-functional components but are low in fat, sodium and calories as compared with many other foods. In terms of body fat, increase vegetable intake that consist of dietary fibre can play an important role in the regulation of body weight. Therefore, the supplementation of dietary fibre intake from vegetable may have benefit in reducing the percentages of body fat. Though, the clinical effect in human remains unclear and currently no study conducted in Malaysia regarding the effectiveness of this plant towards blood sugar control. Apart from that, lower intake of vegetable among Malaysian, lower cost vegetable choices and higher availability of Althernanthera Sissoo (Brazilian Spinach) due to easy growth may benefit the diabetes patient. Therefore, the investigators plan to conduct this study to determine the effectiveness of 12-weeks Brazilian Spinach supplementation on health outcomes among patients with type 2 diabetes especially in Kelantan region. The investigators hypothesized that diabetes patients on supplementation of Brazilian Spinach would have significant differ in terms of anthropometry, biochemical, clinical, and dietary intake compared to control group. Method: A single-center randomized, controlled, and two-arm parallel design clinical trial will be carried out in Malaysia especially in Kelantan region. This study enrols 100 patients from Hospital Universiti Sains Malaysia (HUSM) diagnosed with type 2 diabetes. Diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are Brazilian Spinach treatment group and control group. Both groups will be compared on the primary and secondary outcomes at baseline, 3, 6, and 12 weeks. Discussion: The study will provide insights into the potential beneficial effect of Brazilian Spinach in type 2 diabetic patients. In addition, the therapeutic effect of Brazilian Spinach towards type 2 diabetes will reflect as a change of metabolite profile in serum.

Official Title
-----------------
Effectiveness Of 12-Weeks Brazilian Spinach on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Althernanthera Sissoo
* Behavioral: Dietary Consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 30-65 years old Have confirmed diagnosed with type 2 diabetes mellitus of equal or more than 6 months HbA1c levels equal or more than 7% (within the last 3 months of recruitment) On at least one oral hypoglycemic agent Agree not to take other herbal or nutritional supplements for the duration of study. Exclusion Criteria: Unable to tolerate to fiber especially vegetables Type 1 diabetes mellitus Pregnant Insulin treatment Severe diabetic complications including end-stage renal diseases, liver diseases or gastrointestinal diseases On coagulant therapy (warfarin)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional study: parallel, single and non-blinded study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Intervention: Diabetic Brazilian spinach supplementation group Subjects in this group will be receiving Brazilian spinach for 12 weeks in which they must consume 15g of Brazilian spinach daily with lunch or dinner. | Dietary Supplement: Althernanthera Sissoo<br>* 15g of Althernanthera Sissoo consumed with lunch or dinner per day.<br>* Other names: Brazilian Spinach;|
| Experimental: Control Group<br>No intervention: Diabetic control group Subjects in this group will not receive Brazilian spinach. However, they will be receiving standard dietary counselling and educated for the same lifestyle intervention as in the intervention group. | Behavioral: Dietary Consultation<br>* Dietary consultation to improve the intakes of vegetables daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control (HbA1c level) | The outcome to be measured are the hbA1c level in which it will be measured in percentage. | 3 months | 
| Fasting blood glucose | The outcome to be measured are the fasting blood glucose (FBS) in which it will be measured in mmol/L. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | The outcome to be measured are the BMI in which the weight and height will be combined to report BMI in kg/m^2. | 3 months | 
| Blood pressure | Both pressures, systolic and diastolic will be assessed that will be measured in millimeters of mercury (mmHg). | 3 months | 
| Dietary Intake | The dietary intake will be measured by conducting the 24-hours dietary recall toward the subjects. | 3 months | 
| Liver profile | The outcome to be measured is the liver function test (LFT) which include alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP). This outcome will be measured in units per liter (U/L). | 3 months | 
| Renal profile | The outcome to be measured is the renal function test (RFT) to get an estimate of the glomerular filtration rate (GFR), serum creatine, and to check for proteinuria (albuminuria). | 3 months |