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

NCT ID: NCT05727592

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-09-05

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional study: parallel, single and non-blinded study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Althernanthera Sissoo

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

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.

Group Type EXPERIMENTAL

Dietary Consultation

Intervention Type BEHAVIORAL

Dietary consultation to improve the intakes of vegetables daily

Interventions

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Althernanthera Sissoo

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

Intervention Type DIETARY_SUPPLEMENT

Dietary Consultation

Dietary consultation to improve the intakes of vegetables daily

Intervention Type BEHAVIORAL

Other Intervention Names

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Brazilian Spinach

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Juliana binti Shamsudin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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USM/JEPeM/20120630

Identifier Type: -

Identifier Source: org_study_id