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Completed

NCT Number: NCT04597229

Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Medical and Dental Institute (AMDI)

Kepala Batas, Pulau Pinang, 13200, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the clinical trial are:

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Instant multigrain supplement

Dietary Supplement

A twice daily instant multigrain supplementation for 12 weeks

Primary outcomes

  1. Change of Glycated haemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

    Glycated hemoglobin (HbA1c) is measured in %

  2. Change of fasting plasma glucose (FPG)

    Time frame: Baseline and 12 weeks

    Glycated hemoglobin (HbA1c) is measured in mmol/L

  3. Change of fasting serum insulin

    Time frame: Baseline and 12 weeks

    Fasting serum insulin will be measured by radioimmunoassay kit

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus: A Randomized Human Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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