Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597229
• Other study ID #: LLKuan
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: June 14, 2021

Study information

• Verified date: June 2021
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 14, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• Instant multigrain supplement
A twice daily instant multigrain supplementation for 12 weeks

Locations

Country	Name	City	State
Malaysia	Advanced Medical and Dental Institute (AMDI)	Kepala Batas	Pulau Pinang

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Glycated haemoglobin (HbA1c)	Glycated hemoglobin (HbA1c) is measured in %	Baseline and 12 weeks
Primary	Change of fasting plasma glucose (FPG)	Glycated hemoglobin (HbA1c) is measured in mmol/L	Baseline and 12 weeks
Primary	Change of fasting serum insulin	Fasting serum insulin will be measured by radioimmunoassay kit	Baseline and 12 weeks