The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes: A Case-management Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum IL-1 Level
研究概览
简要总结
The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are:
- What are the effects of the tested regimens on the level of IL-1 and IL-15.
- What are the effects of the tested regimens on the Fasting Blood glucose?
- What are the effects of the tested regimens on the HbA1C?
- What are the effects of the tested regimens on the Body Mass Index?
- What are the effects of the tested regimens on the Lipid profile?
- What are the effects of the tested regimens on C-reactive protein?
- What are the effects of the tested regimens on Hematological indices?
- What are the effects of the tested regimens on Rate pressure product?
Participants will be separated into four groups:
- Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
- Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.
- Group 3 (Diabetes Type 2): 23 Pateins, will be receiving Placebo Capsule per oral once daily for 60 days
- Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.
Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on Fasting Blood Glucose, HbA1c, Lipid profile, Rate pressure product, C-reactive protein, Hematological indices, and Body Mass Index. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apperantly Healthy patients for control
- •Patients diagnosed with T2DM
- •Age between 18-70
排除标准
- •Patients with T1DM
- •Patients with a drug history of anabolic substances for more than 14 days duration.
- •Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders)
- •Pregnancy, lactation, or female patient willing for conception.
研究组 & 干预措施
Group 1 (Healthy Control)
24 Patients receiving Placebo Capsule per oral once daily for 60 days.
干预措施: Placebo (Other)
Group 2 (Healthy control)
26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
干预措施: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) (Drug)
Group 3 (Diabetes Type 2)
23 Patients receiving Placebo Capsule per oral once daily for 60 days.
干预措施: Placebo (Other)
Group 4 (Diabetes Type 2)
27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
干预措施: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) (Drug)
结局指标
主要结局
Serum IL-1 Level
时间窗: at Baseline, and After 60 days of treatment.
Measured in Pg/mL
Serum IL-15 Level
时间窗: at Baseline, and After 60 days of treatment.
Measured in Pg/mL
Hemoglobin A1C (HbA1C)
时间窗: at Baseline, and After 60 days of treatment.
Measured in percent from total Hemoglobin
Fasting Blood Sugar (FBS)
时间窗: at Baseline, and After 60 days of treatment.
Measured in mg/dL
Body Mass Index (BMI)
时间窗: at baseline, and after 60 days of treatment.
Measured in Kg/m²
次要结局
- Rate Pressure Product(at Baseline, and after 60 days of treatment.)
- Serum C-reactive protein (CRP)(At baseline, and after 60 days of treatment)
研究者
Hayder Adnan Fawzi
Assistant Prof
Al-Rasheed University College