An Intervention Study on the Effect of Brazilian Spinach Supplementation on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Althernanthera Sissoo; Dietary Consultation
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): 15g of Althernanthera Sissoo consumed with lunch or dinner per day.; Dietary consultation to improve the intakes of vegetables daily
Other intervention name(s): Brazilian Spinach
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional study: parallel, single and non-blinded study.
Masking: None (Open Label)
Primary purpose: Treatment