Metabolic SyndromeNCT05604300
The Role of Vitamin E Incorporated Oat Supplementation in Metabolic Syndrome (MetS) Patients
A study testing Vitamin E incorporated oat supplement and Oat supplement in people with Metabolic Syndrome, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The objective of this study is to evaluate the effect of vitamin E incorporated oat supplementation among the metabolic syndrome (MetS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Vitamin E incorporated oat supplement and Oat supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2022to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old and above
- Individuals who have been identified as having metabolic syndrome (meet ≥3 out of 5 NCEP-ATP III Criteria)
- Stable weight (± 2 kg during the past 3months) to ensure reliable weight changes with the treatment given.
- Not taking antioxidant/anti-inflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba); (Example of the 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
- 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)
- Hormone replacement therapy (for at least three months prior to entering the study)
- Use of steroids, chemotherapy, immunosuppressant, or radiotherapy
- Currently pregnant or lactating
- 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: Effectiveness of Vitamin E Incorporated Oat Supplementation in Metabolic Syndrome
The objective of this study is to evaluate the effect of vitamin E incorporated oat supplementation among the metabolic syndrome (MetS) patients.
Read the detailed description
Metabolic syndrome (MetS) is a common metabolic disorder, characterized by a cluster of cardiovascular disease (CVD) risk factors including elevated blood glucose level, dyslipidemia, abdominal obesity, and high blood pressure. It was initially introduced by WHO in 1998 as insulin resistance, in addition to two other risk factors, being prerequisites for diagnosis. Other criteria, such as the National Cholesterol Education Program Expert Panel III (ATP III) and the International Diabetes Federation, were later established to improve the diagnosis of MetS. In the new global economy, MetS has become a central issue for public health concern due to the parallel increase in diabetes, CVD, and obesity. Clinical and epidemiological data have indicated that metabolic syndrome starts with central obesity. Since the global incidence of obesity has doubled in the last 30 years, the prevalence of metabolic syndrome has also increased exponentially. Therefore, obesity has been seen to be the primary cause of the metabolic syndrome since it significantly relates to all metabolic risk factors. It was estimated that in 2017, there were 451 million people with diabetes worldwide and is expected to reach 693 million by 2045. Primarily, almost half of the people (49.7%) is estimated to be living with undiagnosed diabetes. These figures signify that obesity and insulin resistance is recognized as the primary pathophysiology underlying metabolic syndrome. Lifestyle intervention including diet control is recommended as the fundamental approach for all patients with metabolic syndrome. One of the discussed components was the potential role of oat-containing beta-glucan in the prevention of metabolic syndrome. The general principle of dietary provision for CVD is by providing a 3-5 serving of whole grain per day throughout the intervention trial. The European
Food Safety Authority gave a favorable view on the health claim for foods containing oat beta glucan:
"Regular consumption of oat b-glucans can actively lower/reduce blood LDL cholesterol and total cholesterol". Despite a large body of studies demonstrating the association between oat consumption and cardiovascular disease, limited information from clinical trials is available on the effective doses of whole-grain consumption on metabolic control. However, it is debatable if a higher provision of whole-grain consumption confers beneficial effects on metabolic syndrome and cardiovascular disease. β-glucan is the most abundant soluble fibre in oats and barley. It has been shown to lower serum cholesterol and improve postprandial insulin and glucose responses in healthy and 3 diabetic adult. While dietary fibre is by far the most essential nutritional feature of whole grains, they also contain a variety of phytochemicals that may have therapeutic metabolic benefits. Alkylresorcinols, flavonoids, lignans, phenolic acids, phytosterols, and tocols (tocopherols and tocotrienols) are among some of the phytochemicals located principally in the outer bran layer. It has been proposed that these and other health benefits of whole grains may be due to a synergistic action of fibre and phytochemical constituents. Furthermore, more studies have suggested a dietary intervention of bioactive enriched as functional foods for adults at risk of metabolic syndrome. However, limited studies have been exploring high fiber consumption and antioxidant properties as distinct and separate dietary management; thus the effectiveness of collective management is not being explored adequately. Furthermore, prospective studies that have examined this association are scarce. Bioactive components have been proposed to confer benefits to reduce the consequential of oxidative stress. Antioxidants, especially the tocotrienols, are among novel compounds studied extensively for their metabolic effects. Tocotrienol, a functional nutritional component exhibiting anti-inflammatory, antioxidant, and cell signaling-mediating properties, could be helpful as an adjuvant treatment for obesity and diabetes diseases. Tocotrienol has been shown to have potent anti-inflammatory and anti-cancer properties by modifying multiple molecular signaling pathways that are usually unaffected by tocopherol. Tocotrienol, particularly γ-tocotrienol lowers the incidence of cardiovascular disease, diabetes, and metabolic syndrome. Moreover, emerging data indicate that tocotrienol is a promising anti-obesity agents by reducing body weight and improve plasma glucose and lipid hepato-protective effects in individuals with nonalcoholic fatty liver disease which is a complication associated with obesity.
Previous study has demonstrated a lower bioavailability of vitamin E among metabolic syndrome patients. This perturbing condition spiked the interest of researchers in incorporating vitamin E in diet modulation. In addition, the lack of studies in MetS people taking vitamin E in typical dietary amounts makes it difficult to make specific nutritional tocotrienol recommendations for this group. Thus, study of tocotrienol pharmacokinetics in MetS is needed and the identification of low-energy, nutrient-dense dietary methods to improve vitamin E status. to search for some potential complementary medicine to combat MetS. The use of oat as food source as part of the dietary regimen, or functional food to alleviate the disease progression is the novel research focus among the scientific communities. However, limited studies have been strategized to outline the efficacy of incorporating vitamin E into functional foods for the amelioration of chronic disease. With the aforementioned, this randomised, placebo-controlled, double-blinded human clinical trial is aimed to determine the efficacy of 12 weeks supplementation of vitamin E incorporated oat products as part of the dietary regimen among the MetS individuals. Secondary and tertiary outcomes include the assessment of circulating antioxidative status and oxidative stress level, inflammatory markers, nutritional status and quality of life. The compliancy and tolerability of the supplementation will be assessed periodically.
- Conditions
- Metabolic Syndrome
- Being tested
- Vitamin E incorporated oat supplement, Oat supplement
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E incorporated oat supplementDietary supplement
A twice daily supplementation of Vitamin E incorporated oat for 12 weeks
Oat supplementDietary supplement
A twice daily supplementation of oat for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E incorporated oat | Active comparator | Oral vitamin E incorporated oat supplementation Receives: Dietary Supplement: Vitamin E incorporated oat supplement |
| Placebo | Placebo comparator | Oral oat supplementation Receives: Dietary Supplement: Oat supplement |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Triacylglycerol concentrations
Triacylglycerol concentration is measured in mg/dL
Measured: Baseline and 12 weeks
Change in HDL-cholesterol concentrations
HDL-cholesterol concentration is measured in mg/dL
Measured: Baseline and 12 weeks
Change in fasting blood glucose concentrations
Fasting blood glucose concentration is measured in mg/dL
Measured: Baseline and 12 weeks
Change in systolic and diastolic blood pressure
Systolic and diastolic blood pressure are measured in mmHg
Measured: Baseline and 12 weeks
Change in waist circumference
Waist circumference is measured in cm
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 posted3 Nov 2022
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Gold Choice Food Industries Sdn. Bhd
- Responsible party
- Principal investigator, Dr. Lee Lai Kuan, Universiti Sains Malaysia
- Investigators
- Lai Kuan Lee, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604300
- Sponsor's protocol ID
- USM/JEPeM/22020101
- Status last verified
- Dec 2023
- First submitted
- 27 Oct 2022
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vitamin E Incorporated Oat Supplementation in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05604300
- Acronym / sponsor ID
- USM/JEPeM/22020101
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Gold Choice Food Industries Sdn. Bhd
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Nov 2022 (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 effect of vitamin E incorporated oat supplementation among the metabolic syndrome (MetS) patients.
Detailed description
Metabolic syndrome (MetS) is a common metabolic disorder, characterized by a cluster of cardiovascular disease (CVD) risk factors including elevated blood glucose level, dyslipidemia, abdominal obesity, and high blood pressure. It was initially introduced by WHO in 1998 as insulin resistance, in addition to two other risk factors, being prerequisites for diagnosis. Other criteria, such as the National Cholesterol Education Program Expert Panel III (ATP III) and the International Diabetes Federation, were later established to improve the diagnosis of MetS. In the new global economy, MetS has become a central issue for public health concern due to the parallel increase in diabetes, CVD, and obesity. Clinical and epidemiological data have indicated that metabolic syndrome starts with central obesity. Since the global incidence of obesity has doubled in the last 30 years, the prevalence of metabolic syndrome has also increased exponentially. Therefore, obesity has been seen to be the primary cause of the metabolic syndrome since it significantly relates to all metabolic risk factors. It was estimated that in 2017, there were 451 million people with diabetes worldwide and is expected to reach 693 million by 2045. Primarily, almost half of the people (49.7%) is estimated to be living with undiagnosed diabetes. These figures signify that obesity and insulin resistance is recognized as the primary pathophysiology underlying metabolic syndrome. Lifestyle intervention including diet control is recommended as the fundamental approach for all patients with metabolic syndrome. One of the discussed components was the potential role of oat-containing beta-glucan in the prevention of metabolic syndrome. The general principle of dietary provision for CVD is by providing a 3-5 serving of whole grain per day throughout the intervention trial. The European
Food Safety Authority gave a favorable view on the health claim for foods containing oat beta glucan:
"Regular consumption of oat b-glucans can actively lower/reduce blood LDL cholesterol and total cholesterol". Despite a large body of studies demonstrating the association between oat consumption and cardiovascular disease, limited information from clinical trials is available on the effective doses of whole-grain consumption on metabolic control. However, it is debatable if a higher provision of whole-grain consumption confers beneficial effects on metabolic syndrome and cardiovascular disease. β-glucan is the most abundant soluble fibre in oats and barley. It has been shown to lower serum cholesterol and improve postprandial insulin and glucose responses in healthy and 3 diabetic adult. While dietary fibre is by far the most essential nutritional feature of whole grains, they also contain a variety of phytochemicals that may have therapeutic metabolic benefits. Alkylresorcinols, flavonoids, lignans, phenolic acids, phytosterols, and tocols (tocopherols and tocotrienols) are among some of the phytochemicals located principally in the outer bran layer. It has been proposed that these and other health benefits of whole grains may be due to a synergistic action of fibre and phytochemical constituents. Furthermore, more studies have suggested a dietary intervention of bioactive enriched as functional foods for adults at risk of metabolic syndrome. However, limited studies have been exploring high fiber consumption and antioxidant properties as distinct and separate dietary management; thus the effectiveness of collective management is not being explored adequately. Furthermore, prospective studies that have examined this association are scarce. Bioactive components have been proposed to confer benefits to reduce the consequential of oxidative stress. Antioxidants, especially the tocotrienols, are among novel compounds studied extensively for their metabolic effects. Tocotrienol, a functional nutritional component exhibiting anti-inflammatory, antioxidant, and cell signaling-mediating properties, could be helpful as an adjuvant treatment for obesity and diabetes diseases. Tocotrienol has been shown to have potent anti-inflammatory and anti-cancer properties by modifying multiple molecular signaling pathways that are usually unaffected by tocopherol. Tocotrienol, particularly γ-tocotrienol lowers the incidence of cardiovascular disease, diabetes, and metabolic syndrome. Moreover, emerging data indicate that tocotrienol is a promising anti-obesity agents by reducing body weight and improve plasma glucose and lipid hepato-protective effects in individuals with nonalcoholic fatty liver disease which is a complication associated with obesity.
Previous study has demonstrated a lower bioavailability of vitamin E among metabolic syndrome patients. This perturbing condition spiked the interest of researchers in incorporating vitamin E in diet modulation. In addition, the lack of studies in MetS people taking vitamin E in typical dietary amounts makes it difficult to make specific nutritional tocotrienol recommendations for this group. Thus, study of tocotrienol pharmacokinetics in MetS is needed and the identification of low-energy, nutrient-dense dietary methods to improve vitamin E status. to search for some potential complementary medicine to combat MetS. The use of oat as food source as part of the dietary regimen, or functional food to alleviate the disease progression is the novel research focus among the scientific communities. However, limited studies have been strategized to outline the efficacy of incorporating vitamin E into functional foods for the amelioration of chronic disease. With the aforementioned, this randomised, placebo-controlled, double-blinded human clinical trial is aimed to determine the efficacy of 12 weeks supplementation of vitamin E incorporated oat products as part of the dietary regimen among the MetS individuals. Secondary and tertiary outcomes include the assessment of circulating antioxidative status and oxidative stress level, inflammatory markers, nutritional status and quality of life. The compliancy and tolerability of the supplementation will be assessed periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin E incorporated oat | Active comparator | Dietary Supplement: Vitamin E incorporated oat supplementOral vitamin E incorporated oat supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Oat supplementOral oat supplementation |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years old and above
- Individuals who have been identified as having metabolic syndrome (meet ≥3 out of 5 NCEP-ATP III Criteria)
- Stable weight (± 2 kg during the past 3months) to ensure reliable weight changes with the treatment given.
- Not taking antioxidant/anti-inflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba); (Example of the anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)
Key exclusion criteria (7 listed)
- Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
- 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)
- Hormone replacement therapy (for at least three months prior to entering the study)
- Use of steroids, chemotherapy, immunosuppressant, or radiotherapy
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 |
|---|---|---|
| Vitamin E incorporated oat supplementA twice daily supplementation of Vitamin E incorporated oat for 12 weeks | Dietary supplement | Vitamin E incorporated oat |
| Oat supplementA twice daily supplementation of oat for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change in Triacylglycerol concentrations
Time frame: Baseline and 12 weeks
Triacylglycerol concentration is measured in mg/dL
Change in HDL-cholesterol concentrations
Time frame: Baseline and 12 weeks
HDL-cholesterol concentration is measured in mg/dL
Change in fasting blood glucose concentrations
Time frame: Baseline and 12 weeks
Fasting blood glucose concentration is measured in mg/dL
Change in systolic and diastolic blood pressure
Time frame: Baseline and 12 weeks
Systolic and diastolic blood pressure are measured in mmHg
Change in waist circumference
Time frame: Baseline and 12 weeks
Waist circumference is measured in cm
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 8 Dec 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.
Lai Kuan Lee, PhD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E incorporated oat supplement and Oat supplement in people with Metabolic Syndrome, 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 4 inclusion and 7 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 8 Dec 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. Some participants in this study may receive a placebo. 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 in Triacylglycerol concentrations (time frame: Baseline and 12 weeks). The study lists 5 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 8 Dec 2023.