Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The fasting blood sugar level
研究概览
简要总结
This study is set up to determine the consumption safety and the effect of a food supplement containing dietary fiber from cassava on the alterations of physiological parameters including fasting blood sugar, HbA1c, insulin resistance, lipid profiles, atherogenic index, blood pressure and gut microbes in overweight female volunteers.
详细描述
Cassava is one of the important industrial crops in Thailand. The leftover fiber of cassava is still valuable and can be used as a dietary fiber. The previous study demonstrated that dietary fiber containing cassava fiber was safe for consumption without any contamination of the cyanide and heavy metals. Moreover, the microbial contaminations were within the safety range. The toxicity study revealed that the LD50 of the cassava dietary fiber was more than 5 g/kg body weight (BW) and NOAEL was 3 g/kg BW. The NOAEL was used to calculate the human equivalent dose for determining the effect of cassava dietary fiber in a clinical study.
Cassava dietary fiber consists of water-insoluble fiber such as cellulose more than 50%. The previous study showed that insoluble fiber decreased the risk of type 2 diabetes and increased insulin release. Moreover, a high fiber diet also decreased the fasting glucose and HbA1C in type 2 diabetes volunteer. In addition, the effect of dietary fiber on the reduction of cholesterol was also reported. The previous study reported that the cassava dietary fiber could decrease the total cholesterol, triglyceride but increase high-density lipoprotein in a dyslipidemia rat model. Therefore, the cassava fiber might be the potential food supplement for the control of blood sugar and lipid profiles in human. However, less scientific data support the effect of cassava dietary fiber in human.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women age between 35-60 years old
- •BMI 23-29.99
- •Blood pressure <140/90 mmHg
- •Fasting plasma glucose < 100 mg/dL
排除标准
- •Presence of any chronic diseases
- •Alcohol addict or consume more than 2 units/day
- •Smoking more than 10 cigarettes per day
- •Medication or herbal medicine usage within 1 month prior to the study
- •Use any medication or food supplement which affect to outcomes
- •Pregnant or breastfeeding women
结局指标
主要结局
The fasting blood sugar level
时间窗: Baseline and 4 weeks of intervention
The previous study reported that high dietary fiber could decrease the fasting blood sugar in type 2 diabetes patient. The overweight female volunteer receive food supplement containing dietary fiber from Cassava should show the lower level of fasting blood sugar than the placebo-treated group after 4 weeks of intervention.
The atherogenic index
时间窗: 4 weeks of intervention
The atherogenic index is an index composed of triglycerides and high-density lipoprotein cholesterol. It has been used to quantify blood lipid levels and commonly used as an optimal indicator of dyslipidemia and associated diseases. The food supplement containing dietary fiber from Cassava might be able to decrease the atherogenic index in overweight female volunteer. The overweight female volunteer receive food supplement containing dietary fiber from Cassava should show the lower number of the atherogenic index than the placebo-treated group after 4 weeks of intervention.
次要结局
- Consumption safety of food supplement containing dietary fiber from Cassava using hematolgical values.(4 weeks of intervention)
- hemoglobin A1c concentration(4 weeks of intervention)
- Homeostasis model assessment-insulin resistance (HOMA-IR)(4 weeks of intervention)
- Low-density lipoprotein (LDL) concentration(4 weeks of intervention)
- High-density lipoprotein (HDL) concentration(4 weeks of intervention)
- Triglyceride (TG) concentration(4 weeks of intervention)
- Cholesterol concentration(4 weeks of intervention)
- Body mass index (BMI)(4 weeks of intervention)
- Gut microbes(4 weeks of intervention)
- The consumption safety of food supplement containing dietary fiber from Cassava using Systolic and Diastolic Blood pressure(4 weeks of intervention)
- The consumption safety of food supplement containing dietary fiber from Cassava using the electrocardiogram pattern and QT interval data(4 weeks of intervention)
- Consumption safety of food supplement containing dietary fiber from Cassava using blood chemistry(4 weeks of intervention)
研究者
Jintanaporn Wattanathorn
Associated Professor
Khon Kaen University