OverweightPhase 1NCT04013490
Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
A Phase 1 study testing Cassava dietary fiber capsule in people with Overweight, run by Khon Kaen University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Cassava dietary fiber capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- 27 Feb 2019to 31 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women age between 35-60 years old
- BMI 23-29.99
- Blood pressure <140/90 mmHg
- Fasting plasma glucose < 100 mg/dL
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Cassava dietary fiber capsule
- Keywords
- physiological parameters, consumption safety, cassava, food supplement, overweight female
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cassava dietary fiber capsuleDietary supplement
Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsule | Placebo comparator | Subject receive the Placebo product for 4 weeks. Receives: Dietary Supplement: Cassava dietary fiber capsule |
| Cassava dietary fiber capsule 1.5 g/day | Active comparator | Subjects receive Cassava dietary fiber capsule at the dose of 1.5 g/day for 4 weeks. Receives: Dietary Supplement: Cassava dietary fiber capsule |
| Cassava dietary fiber capsule 3 g/day | Active comparator | Subjects receive Cassava dietary fiber capsule at the dose of 3 g/day for 4 weeks. Receives: Dietary Supplement: Cassava dietary fiber capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fasting blood sugar level
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.
Measured: Baseline and 4 weeks of intervention
The atherogenic index
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.
Measured: 4 weeks of intervention
Secondary outcomes (12)
hemoglobin A1c concentration
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.
Measured: 4 weeks of intervention
Homeostasis model assessment-insulin resistance (HOMA-IR)
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.
Measured: 4 weeks of intervention
Low-density lipoprotein (LDL) concentration
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.
Measured: 4 weeks of intervention
High-density lipoprotein (HDL) concentration
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.
Measured: 4 weeks of intervention
Triglyceride (TG) concentration
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.
Measured: 4 weeks of intervention
Cholesterol concentration
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.
Measured: 4 weeks of intervention
Body mass index (BMI)
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.
Measured: 4 weeks of intervention
Gut microbes
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.
Measured: 4 weeks of intervention
The consumption safety of food supplement containing dietary fiber from Cassava using Systolic and Diastolic Blood pressure
If the supplement containing dietary fiber from Cassava is safe, the blood pressure should be within the normal range.
Measured: 4 weeks of intervention
The consumption safety of food supplement containing dietary fiber from Cassava using the electrocardiogram pattern and QT interval data
If the supplement containing dietary fiber from Cassava is safe, the EKG pattern and the QT interval should be within the normal range.
Measured: 4 weeks of intervention
Consumption safety of food supplement containing dietary fiber from Cassava using blood chemistry
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.
Measured: 4 weeks of intervention
Consumption safety of food supplement containing dietary fiber from Cassava using hematolgical values.
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.
Measured: 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start27 Feb 2019
- Primary completion31 Jul 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jintanaporn Wattanathorn, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013490
- Sponsor's protocol ID
- HE611054
- Status last verified
- Feb 2020
- First submitted
- 20 Jun 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
- ClinicalTrials.gov ID
- NCT04013490
- Acronym / sponsor ID
- HE611054
- Conditions
- Overweight
- Keywords
- physiological parameters, consumption safety, cassava, food supplement, overweight female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo capsule | Placebo comparator | Dietary Supplement: Cassava dietary fiber capsuleSubject receive the Placebo product for 4 weeks. |
| Cassava dietary fiber capsule 1.5 g/day | Active comparator | Dietary Supplement: Cassava dietary fiber capsuleSubjects receive Cassava dietary fiber capsule at the dose of 1.5 g/day for 4 weeks. |
| Cassava dietary fiber capsule 3 g/day | Active comparator | Dietary Supplement: Cassava dietary fiber capsuleSubjects receive Cassava dietary fiber capsule at the dose of 3 g/day for 4 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy women age between 35-60 years old
- BMI 23-29.99
- Blood pressure <140/90 mmHg
- Fasting plasma glucose < 100 mg/dL
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cassava dietary fiber capsuleCassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group. | Dietary supplement | Cassava dietary fiber capsule 1.5 g/day, Cassava dietary fiber capsule 3 g/day, Placebo capsule |
Primary outcome
The fasting blood sugar level
Time frame: 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
Time frame: 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.
12 secondary outcomes
hemoglobin A1c concentration
Time frame: 4 weeks of intervention
Homeostasis model assessment-insulin resistance (HOMA-IR)
Time frame: 4 weeks of intervention
Low-density lipoprotein (LDL) concentration
Time frame: 4 weeks of intervention
High-density lipoprotein (HDL) concentration
Time frame: 4 weeks of intervention
Triglyceride (TG) concentration
Time frame: 4 weeks of intervention
Cholesterol concentration
Time frame: 4 weeks of intervention
Body mass index (BMI)
Time frame: 4 weeks of intervention
Gut microbes
Time frame: 4 weeks of intervention
The consumption safety of food supplement containing dietary fiber from Cassava using Systolic and Diastolic Blood pressure
Time frame: 4 weeks of intervention
The consumption safety of food supplement containing dietary fiber from Cassava using the electrocardiogram pattern and QT interval data
Time frame: 4 weeks of intervention
Consumption safety of food supplement containing dietary fiber from Cassava using blood chemistry
Time frame: 4 weeks of intervention
Consumption safety of food supplement containing dietary fiber from Cassava using hematolgical values.
Time frame: 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cassava dietary fiber capsule in people with Overweight, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fasting blood sugar level (time frame: Baseline and 4 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.