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Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04597229
Recruitment Status : Completed
First Posted : October 22, 2020
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Lee Lai Kuan, Universiti Sains Malaysia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dietary Supplement: Instant multigrain supplement Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus: A Randomized Human Clinical Trial
Actual Study Start Date : September 28, 2020
Actual Primary Completion Date : May 26, 2021
Actual Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Instant multigrain
Oral instant multigrain supplement
 Dietary Supplement: Instant multigrain supplement
A twice daily instant multigrain supplementation for 12 weeks
No Intervention: Standard care
Standard care without oral instant multigrain supplement


Outcome Measures
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Primary Outcome Measures :
  1. Change of Glycated haemoglobin (HbA1c) [ Time Frame: Baseline and 12 weeks ]
    Glycated hemoglobin (HbA1c) is measured in %

  2. Change of fasting plasma glucose (FPG) [ Time Frame: Baseline and 12 weeks ]
    Glycated hemoglobin (HbA1c) is measured in mmol/L

  3. Change of fasting serum insulin [ Time Frame: Baseline and 12 weeks ]
    Fasting serum insulin will be measured by radioimmunoassay kit


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597229


Locations
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Malaysia
Advanced Medical and Dental Institute (AMDI)
Kepala Batas, Pulau Pinang, Malaysia, 13200
Sponsors and Collaborators
Universiti Sains Malaysia
More Information
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Responsible Party: Dr. Lee Lai Kuan, Principal Investigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT04597229    
Other Study ID Numbers: LLKuan
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases