Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    50
  • sponsor
    Universiti Sains Malaysia
Updated on 25 January 2021

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.

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 benets 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.

Details
Condition Type2 Diabetes
Treatment Instant multigrain supplement
Clinical Study IdentifierNCT04597229
SponsorUniversiti Sains Malaysia
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 21 yrs?
Gender: Male or Female
Do you have Type2 Diabetes?
Do you have any of these conditions: Do you have Type2 Diabetes??
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
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