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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Malaysia

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.

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 groups in NCT05604300
Study groupRoleWhat they receive
Vitamin E incorporated oatActive comparatorOral vitamin E incorporated oat supplementation
Receives: Dietary Supplement: Vitamin E incorporated oat supplement
PlaceboPlacebo comparatorOral oat supplementation
Receives: Dietary Supplement: Oat supplement
ControlNo interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Triacylglycerol concentrations

    Triacylglycerol concentration is measured in mg/dL

    Measured: Baseline and 12 weeks

  2. Change in HDL-cholesterol concentrations

    HDL-cholesterol concentration is measured in mg/dL

    Measured: Baseline and 12 weeks

  3. Change in fasting blood glucose concentrations

    Fasting blood glucose concentration is measured in mg/dL

    Measured: Baseline and 12 weeks

  4. Change in systolic and diastolic blood pressure

    Systolic and diastolic blood pressure are measured in mmHg

    Measured: Baseline and 12 weeks

  5. 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.

  1. First posted3 Nov 2022
  2. Study start1 Jun 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Nov 2023

Resources

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)
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

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.

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