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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo capsule

Subject receive the Placebo product for 4 weeks.

Group Type PLACEBO_COMPARATOR

Cassava dietary fiber capsule

Intervention Type DIETARY_SUPPLEMENT

Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.

Cassava dietary fiber capsule 1.5 g/day

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

Group Type ACTIVE_COMPARATOR

Cassava dietary fiber capsule

Intervention Type DIETARY_SUPPLEMENT

Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.

Cassava dietary fiber capsule 3 g/day

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

Group Type ACTIVE_COMPARATOR

Cassava dietary fiber capsule

Intervention Type DIETARY_SUPPLEMENT

Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.

Interventions

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Cassava dietary fiber capsule

Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes