Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers

Khon Kaen University

Status and phase: Completed; Phase 1

Conditions: Overweight

Treatments: Dietary Supplement: Cassava dietary fiber capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04013490

HE611054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Placebo capsule

Placebo Comparator group

Description:

Subject receive the Placebo product for 4 weeks.

Treatment:

Dietary Supplement: Cassava dietary fiber capsule

Cassava dietary fiber capsule 1.5 g/day

Active Comparator group

Description:

Subjects receive Cassava dietary fiber capsule at the dose of 1.5 g/day for 4 weeks.

Treatment:

Dietary Supplement: Cassava dietary fiber capsule

Cassava dietary fiber capsule 3 g/day

Active Comparator group

Description:

Subjects receive Cassava dietary fiber capsule at the dose of 3 g/day for 4 weeks.

Treatment:

Dietary Supplement: Cassava dietary fiber capsule