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NCT Number: NCT05727592

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Althernanthera Sissoo

Dietary Supplement

15g of Althernanthera Sissoo consumed with lunch or dinner per day.

Other names: Brazilian Spinach

Dietary Consultation

Behavioral

Dietary consultation to improve the intakes of vegetables daily

Primary outcomes

  1. Glycaemic control (HbA1c level)

    Time frame: 3 months

    The outcome to be measured are the hbA1c level in which it will be measured in percentage.

  2. Fasting blood glucose

    Time frame: 3 months

    The outcome to be measured are the fasting blood glucose (FBS) in which it will be measured in mmol/L.

Secondary outcomes

  1. Anthropometric measurements

    Time frame: 3 months

    The outcome to be measured are the BMI in which the weight and height will be combined to report BMI in kg/m^2.

  2. Blood pressure

    Time frame: 3 months

    Both pressures, systolic and diastolic will be assessed that will be measured in millimeters of mercury (mmHg).

  3. Dietary Intake

    Time frame: 3 months

    The dietary intake will be measured by conducting the 24-hours dietary recall toward the subjects.

  4. Liver profile

    Time frame: 3 months

    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).

  5. Renal profile

    Time frame: 3 months

    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).

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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