Clinical trial NCT04013490: Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
Official title: Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Keywords: physiological parameters
consumption safety
cassava
food supplement
overweight female
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 75
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy women age between 35-60 years old
* BMI 23-29.99
* Blood pressure \<140/90 mmHg
* Fasting plasma glucose \< 100 mg/dL

Exclusion Criteria:

* 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
* Athlete

Primary outcomes:
measure: The fasting blood sugar level
timeFrame: Baseline and 4 weeks of intervention
measure: The atherogenic index
timeFrame: 4 weeks of intervention
Secondary outcomes:
measure: hemoglobin A1c concentration
timeFrame: 4 weeks of intervention
measure: Homeostasis model assessment-insulin resistance (HOMA-IR)
timeFrame: 4 weeks of intervention
measure: Low-density lipoprotein (LDL) concentration
timeFrame: 4 weeks of intervention
measure: High-density lipoprotein (HDL) concentration
timeFrame: 4 weeks of intervention
measure: Triglyceride (TG) concentration
timeFrame: 4 weeks of intervention
measure: Cholesterol concentration
timeFrame: 4 weeks of intervention
measure: Body mass index (BMI)
timeFrame: 4 weeks of intervention
measure: Gut microbes
timeFrame: 4 weeks of intervention
measure: The consumption safety of food supplement containing dietary fiber from Cassava using Systolic and Diastolic Blood pressure
timeFrame: 4 weeks of intervention
measure: The consumption safety of food supplement containing dietary fiber from Cassava using the electrocardiogram pattern and QT interval data
timeFrame: 4 weeks of intervention
measure: Consumption safety of food supplement containing dietary fiber from Cassava using blood chemistry
timeFrame: 4 weeks of intervention
measure: Consumption safety of food supplement containing dietary fiber from Cassava using hematolgical values.
timeFrame: 4 weeks of intervention
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Jitanaporn Wattanathorn
Study officials:
References: