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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05727592
• Other study ID #: USM/JEPeM/20120630
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: September 5, 2023

Study information

• Verified date: November 2023
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 5, 2023
• Est. primary completion date: June 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Althernanthera Sissoo
15g of Althernanthera Sissoo consumed with lunch or dinner per day.

Behavioral:
• Dietary Consultation
Dietary consultation to improve the intakes of vegetables daily

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic control (HbA1c level)	The outcome to be measured are the hbA1c level in which it will be measured in percentage.	3 months
Primary	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	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
Secondary	Blood pressure	Both pressures, systolic and diastolic will be assessed that will be measured in millimeters of mercury (mmHg).	3 months
Secondary	Dietary Intake	The dietary intake will be measured by conducting the 24-hours dietary recall toward the subjects.	3 months
Secondary	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
Secondary	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