Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Universiti Sains Malaysia

Status

Completed

Conditions

Type2 Diabetes

Treatments

Dietary Supplement: Instant multigrain supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT04597229

LLKuan

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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