Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus: A Randomized Human Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of fasting serum insulin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change of fasting serum insulin
时间窗: Baseline and 12 weeks
Fasting serum insulin will be measured by radioimmunoassay kit
Change of Glycated haemoglobin (HbA1c)
时间窗: Baseline and 12 weeks
Glycated hemoglobin (HbA1c) is measured in %
Change of fasting plasma glucose (FPG)
时间窗: Baseline and 12 weeks
Glycated hemoglobin (HbA1c) is measured in mmol/L
次要结局
未报告次要终点
研究者
Dr. Lee Lai Kuan
Principal Investigator
Universiti Sains Malaysia