Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

NCT04597229 | Completed DMC

• 1 other identifier: LLKuan
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Change of Glycated haemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c) is measured in %

  Baseline and 12 weeks

• Change of fasting plasma glucose (FPG)

  Glycated hemoglobin (HbA1c) is measured in mmol/L

  Baseline and 12 weeks

• Change of fasting serum insulin

  Fasting serum insulin will be measured by radioimmunoassay kit

  Baseline and 12 weeks

Study Arms (2)

Instant multigrain

ACTIVE COMPARATOR

Oral instant multigrain supplement

Dietary Supplement: Instant multigrain supplement

Standard care

NO INTERVENTION

Standard care without oral instant multigrain supplement

Interventions

Instant multigrain supplement DIETARY_SUPPLEMENT

A twice daily instant multigrain supplementation for 12 weeks

Instant multigrain

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Advanced Medical and Dental Institute (AMDI)

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: September 28, 2020
• Primary Completion: May 26, 2021
• Study Completion: June 14, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)