Clinical trial NCT05727592: An Intervention Study on the Effect of Brazilian Spinach Supplementation on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
Official title: Effectiveness Of 12-Weeks Brazilian Spinach on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study: parallel, single and non-blinded study.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Glycaemic control (HbA1c level)
timeFrame: 3 months
measure: Fasting blood glucose
timeFrame: 3 months
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Dietary Intake
timeFrame: 3 months
measure: Liver profile
timeFrame: 3 months
measure: Renal profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
References: