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Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Primary Purpose

Type2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Instant multigrain supplement

About this trial

This is an interventional supportive care trial for Type2 Diabetes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Advanced Medical and Dental Institute (AMDI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Instant multigrain

Standard care

Arm Description

Oral instant multigrain supplement

Standard care without oral instant multigrain supplement

Outcomes

Primary Outcome Measures

Change of Glycated haemoglobin (HbA1c)

Glycated hemoglobin (HbA1c) is measured in %

Change of fasting plasma glucose (FPG)

Glycated hemoglobin (HbA1c) is measured in mmol/L

Change of fasting serum insulin

Fasting serum insulin will be measured by radioimmunoassay kit

Secondary Outcome Measures

Full Information

NCT ID

NCT04597229

First Posted

October 14, 2020

Last Updated

June 14, 2021

Sponsor

Universiti Sains Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT04597229

Brief Title

Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

September 28, 2020 (Actual)

Primary Completion Date

May 26, 2021 (Actual)

Study Completion Date

June 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Instant multigrain

Arm Type

Active Comparator

Arm Description

Oral instant multigrain supplement

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Standard care without oral instant multigrain supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Instant multigrain supplement

Intervention Description

A twice daily instant multigrain supplementation for 12 weeks

Primary Outcome Measure Information:

Title

Change of Glycated haemoglobin (HbA1c)

Description

Glycated hemoglobin (HbA1c) is measured in %

Time Frame

Baseline and 12 weeks

Title

Change of fasting plasma glucose (FPG)

Description

Glycated hemoglobin (HbA1c) is measured in mmol/L

Time Frame

Baseline and 12 weeks

Title

Change of fasting serum insulin

Description

Fasting serum insulin will be measured by radioimmunoassay kit

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Advanced Medical and Dental Institute (AMDI)

City

Kepala Batas

State/Province

Pulau Pinang

ZIP/Postal Code

13200

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

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