Subject receive the Placebo product for 4 weeks.

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

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

Overweight

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

Cassava dietary fiber capsule

Jitanaporn Wattanathorn

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

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 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.

A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. This result shows the average amount of glucose attached to hemoglobin has been over the past three months. The previous study reported that high dietary fiber could decrease the HbA1C in type 2 diabetes patient. The food supplement containing dietary fiber from Cassava might be able to decrease the HbA1C in overweight female volunteer. The overweight female volunteer receive food supplement containing dietary fiber from Cassava should show the lower HbA1C level than the placebo-treated group after 4 weeks of intervention.

HOMA-IR was computed with the formula: fasting plasma glucose (mmol/l) multiplied fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show the lower HOMA-IR than the placebo-treated group after 4 weeks of intervention.

LDL is considered bad cholesterol and a leading cause of atherosclerosis formation. The food supplement containing dietary fiber from Cassava might be able to decrease the LDL level in overweight female volunteer. The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show the lower LDL concentration than the placebo-treated group after 4 weeks of intervention.

HDL is considered as good cholesterol and believed that it acts as a scavenger and carrying of LDL from the arteries back to the liver. The food supplement containing dietary fiber from Cassava might be able to increase the LDL level in overweight female volunteer. The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show a higher HDL concentration than the placebo-treated group after 4 weeks of intervention.

TG is one type of fat in the blood which converted from the excess energy from the diet. A high triglyceride level combined with high LDL (bad) cholesterol or low HDL (good) cholesterol is linked with fatty buildups within the artery walls, which increases the risk of heart attack and stroke in an overweight person. The food supplement containing dietary fiber from Cassava might be able to decrease the LDL level in overweight female volunteer. The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show the lower TG concentration than the placebo-treated group after 4 weeks of intervention.

The high level of cholesterol is a cause of atherosclerosis in the blood vessel. The food supplement containing dietary fiber from Cassava might be able to decrease the cholesterol level in overweight female volunteer. The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show the lower cholesterol concentration than the placebo-treated group after 4 weeks of intervention.

The food supplement containing dietary fiber from Cassava might be able to decrease the BMI in overweight female volunteer. The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show the lower BMI than the placebo-treated group after 4 weeks of intervention.

It has been reported that the dysbiosis can cause the alteration of glucose metabolism, lipid metabolism, and dyslipidemia. Moreover, the high fiber diet causes the elevation of good bacteria in the gut and exert many effects. The food supplement containing dietary fiber from Cassava might be able to increase the good gut microbes in overweight female volunteer. The overweight female volunteers receive food supplement containing dietary fiber from Cassava should show higher gut microbes than the placebo-treated group after 4 weeks of intervention.

If the supplement containing dietary fiber from Cassava is safe, the blood pressure should be within the normal range.

If the supplement containing dietary fiber from Cassava is safe, the EKG pattern and the QT interval should be within the normal range.

The blood chemistry values including renal function test, liver function test, and electrolytes will be determined and the data will be expressed as the number of subjects presented with abnormal blood chemistry value.

The hematological values including red blood cell, white blood cell, hematocrit, and platelet will be determined and the data will be expressed as a number of subjects presented with abnormal hematological value.

Jintanaporn Wattanathorn

Associated Professor

Khon Kaen University

Diet Modification

2 flavonoid/caffeine capsules before breakfast, 2 capsules before lunch

Flavonoid, caffeine

2 placebo capsules before breakfast, 2 capsules before lunch

Placebo

Appalachian State University Human Performance Lab, North Carolina Research Campus

Influence of Flavonoids and Caffeine Supplementation on Resting Metabolism

A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of Mixed Flavonoid and Caffeine Ingestion on Energy Expenditure and Fat Oxidation in Healthy Adult Women

Energy expenditure (kilocalories) over 24 h in metabolic chamber with oxygen consumption and carbon dioxide production analyzers whereby energy expenditure is calculated from respiratory exchange data (oxygen consumption, carbon dioxide production) using standard equations

Fat oxidation (fat grams) over 24 h in metabolic chamber with oxygen consumption and carboh dioxide production analyzers whereby fat oxidation (grams/minute) is calculated from respiratory exchange data (oxygen consumption, carbon dioxide production) using standard equations

Appalachian State University

University of North Carolina, Chapel Hill

Supplement of flaxseed powder (60 g/day)during 12 weeks

Placebo powder supplement 60 g/day during 12 weeks

Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks

Safflower oil 30 ml/day (no ALA) during 12 weeks

manihot dichotoma/obesity

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

Influence of Flavonoids and Caffeine Supplementation on Resting Metabolism

Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation

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