Type 2 Diabetes MellitusNCT05727592
An Intervention Study on the Effect of Brazilian Spinach Supplementation on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
A study testing Althernanthera Sissoo and Dietary Consultation in people with Type 2 Diabetes Mellitus, run by Universiti Sains Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Althernanthera Sissoo and Dietary Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Mar 2023to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official title: Effectiveness Of 12-Weeks Brazilian Spinach 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Althernanthera Sissoo, Dietary Consultation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Althernanthera SissooDietary supplement
Also called Brazilian Spinach
15g of Althernanthera Sissoo consumed with lunch or dinner per day.
Dietary ConsultationBehavioural
Dietary consultation to improve the intakes of vegetables daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Dietary Supplement: Althernanthera Sissoo |
| Control Group | Experimental | 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. Receives: Behavioral: Dietary Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic control (HbA1c level)
The outcome to be measured are the hbA1c level in which it will be measured in percentage.
Measured: 3 months
Fasting blood glucose
The outcome to be measured are the fasting blood glucose (FBS) in which it will be measured in mmol/L.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 months
Blood pressure
Both pressures, systolic and diastolic will be assessed that will be measured in millimeters of mercury (mmHg).
Measured: 3 months
Dietary Intake
The dietary intake will be measured by conducting the 24-hours dietary recall toward the subjects.
Measured: 3 months
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).
Measured: 3 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start20 Mar 2023
- Primary completion17 Jun 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study: parallel, single and non-blinded study.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana binti Shamsudin, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727592
- Sponsor's protocol ID
- USM/JEPeM/20120630
- Status last verified
- Nov 2023
- First submitted
- 29 Dec 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of 12-Weeks Brazilian Spinach on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
- ClinicalTrials.gov ID
- NCT05727592
- Acronym / sponsor ID
- USM/JEPeM/20120630
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional study: parallel, single and non-blinded study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Althernanthera SissooIntervention: 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. |
| Control Group | Experimental | Behavioral: Dietary ConsultationNo 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Althernanthera SissooAlso: Brazilian Spinach15g of Althernanthera Sissoo consumed with lunch or dinner per day. | Dietary supplement | Intervention Group |
| Dietary ConsultationDietary consultation to improve the intakes of vegetables daily | Behavioural | Control Group |
Primary outcome
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.
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.
5 secondary outcomes
Anthropometric measurements
Time frame: 3 months
Blood pressure
Time frame: 3 months
Dietary Intake
Time frame: 3 months
Liver profile
Time frame: 3 months
Renal profile
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Althernanthera Sissoo and Dietary Consultation in people with Type 2 Diabetes Mellitus, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (HbA1c level) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.