Type2 DiabetesNCT04597229
Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus
A study testing Instant multigrain supplement in people with Type2 Diabetes, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The objective of this study is to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Instant multigrain supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 28 Sep 2020to 14 Jun 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis with Type II DM for at least 6 months' duration without clinically manifest complications (retinopathy, diabetic nephropathy, vascular diseases, foot ulcer - as diagnosed by the physician/recorded in database)
- Male or female
- Pharmacological treatment with metformin or insulin, or a combination of metformin and glibenclamide.
- Chronological age: 18 years and above
- Metabolically stable (current laboratory results for A1C 6.0-8.5%; or fasting plasma glucose 6.4-8.5 mmol/l)
- Not taking antioxidant/anti-inflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba) (Example of anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)
Who cannot join
- Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
- Active gastric/duodenal ulcer
- Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia)
- Cancer (all types), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
- Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
- Gestational Diabetes Mellitus
Show all 13Show fewer
- Pregnancy/lactation
- Hormone replacement therapy (for at least 3 months prior to entering the study)
- Herbal remedies (any parts from the plants such as flowers, rhizome, seeds, roots, leaves, fruits, stems)
- Use of steroids, chemotherapy, immunosuppressant or radiotherapy.
- Vegetarian patient (pure vegan)
- Gluten intolerance
- Participations currently under another supplementary program
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Advanced Medical and Dental Institute (AMDI)
Kepala Batas, Pulau Pinang, 13200
About this study
Official title: Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus: A Randomized Human Clinical Trial
The objective of this study is to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients.
Read the detailed description
Type II DM is a highly prevalent and heterogeneous condition. New treatment modalities to complement existing interventions are therefore of great interest, including dietary interventions for primary prevention or as a possible therapeutic option that may confer benefits beyond currently recommended conventional therapies. Hence, the present work aims to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients, as compare to standardized medication regimen.
- Conditions
- Type2 Diabetes
- Being tested
- Instant multigrain supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instant multigrain supplementDietary supplement
A twice daily instant multigrain supplementation for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Instant multigrain | Active comparator | Oral instant multigrain supplement Receives: Dietary Supplement: Instant multigrain supplement |
| Standard care | No intervention | Standard care without oral instant multigrain supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Glycated haemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) is measured in %
Measured: Baseline and 12 weeks
Change of fasting plasma glucose (FPG)
Glycated hemoglobin (HbA1c) is measured in mmol/L
Measured: Baseline and 12 weeks
Change of fasting serum insulin
Fasting serum insulin will be measured by radioimmunoassay kit
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start28 Sep 2020
- Primary completion26 May 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lee Lai Kuan, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597229
- Sponsor's protocol ID
- LLKuan
- Status last verified
- Jun 2021
- First submitted
- 14 Oct 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus: A Randomized Human Clinical Trial
- ClinicalTrials.gov ID
- NCT04597229
- Acronym / sponsor ID
- LLKuan
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 22 Oct 2020 (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 objective of this study is to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients.
Detailed description
Type II DM is a highly prevalent and heterogeneous condition. New treatment modalities to complement existing interventions are therefore of great interest, including dietary interventions for primary prevention or as a possible therapeutic option that may confer benefits beyond currently recommended conventional therapies. Hence, the present work aims to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients, as compare to standardized medication regimen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instant multigrain | Active comparator | Dietary Supplement: Instant multigrain supplementOral instant multigrain supplement |
| Standard care | No intervention | –Standard care without oral instant multigrain supplement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis with Type II DM for at least 6 months' duration without clinically manifest complications (retinopathy, diabetic nephropathy, vascular diseases, foot ulcer - as diagnosed by the physician/recorded in database)
- Male or female
- Pharmacological treatment with metformin or insulin, or a combination of metformin and glibenclamide.
- Chronological age: 18 years and above
- Metabolically stable (current laboratory results for A1C 6.0-8.5%; or fasting plasma glucose 6.4-8.5 mmol/l)
Key exclusion criteria (13 listed)
- Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
- Active gastric/duodenal ulcer
- Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia)
- Cancer (all types), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
- Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
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 |
|---|---|---|
| Instant multigrain supplementA twice daily instant multigrain supplementation for 12 weeks | Dietary supplement | Instant multigrain |
Primary outcome
Change of Glycated haemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Glycated hemoglobin (HbA1c) is measured in %
Change of fasting plasma glucose (FPG)
Time frame: Baseline and 12 weeks
Glycated hemoglobin (HbA1c) is measured in mmol/L
Change of fasting serum insulin
Time frame: Baseline and 12 weeks
Fasting serum insulin will be measured by radioimmunoassay kit
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 16 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Type2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Instant multigrain supplement in people with Type2 Diabetes, 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 6 inclusion and 13 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 16 Jun 2021. 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?
Change of Glycated haemoglobin (HbA1c) (time frame: Baseline and 12 weeks). The study lists 3 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 16 Jun 2021.