Resistant StarchNCT07282496
Evaluation of VEDAN RT-90 Resistant Cassava Starch for Glycemic Control and Prebiotic Fiber Development in a Human Trial
A study testing RT-90 resistant tapioca starch and Commercially available resistant starch in people with Resistant Starch and Tapioca Starch, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
This study aims to investigate the effects of RT-90 resistant cassava starch on glycemic control using a human dietary trial and to evaluate its potential as a prebiotic fiber supplement. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistant Starch, Tapioca Starch, Prebiotic Fiber
- What is being tested?
- RT-90 resistant tapioca starch and Commercially available resistant starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Dec 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18-65 years.
- Healthy subjects (BMI between 18.5-24.9 kg/m² for women and men).
- Subjects must be able to maintain a stable diet (based on the Ministry of Health and Welfare's daily dietary guidelines, with a tolerance of ± 10-15%) and physical activity (based on the World Health Organization's recommendations of 150-300 minutes of moderate-intensity exercise per week, or equivalent physical activity, with a tolerance of ± 20%) during the trial period.
- Subjects must understand the trial procedures and potential risks and benefits described in the consent form and be able to sign the consent form.
Who cannot join
- Pregnant or breastfeeding women.
- Subjects with endocrine abnormalities, major organ disease, or mental illness (as determined by a physician).
- Subjects found to be intolerant to the test sample during the trial.
- Subjects who develop a disease or take medications or health supplements that could affect the results of the trial during the trial period. (e.g., hypoglycemic (lipid)-lowering medications, probiotics, high-dose dietary fiber supplements, fish oil, or supplements high in polyunsaturated fatty acids).
- Chronic gastrointestinal diseases (e.g., diverticular disease, irritable bowel syndrome, or other intestinal diseases that may cause constipation).
- Use of antibiotics within the past three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chung Shan Medical University
Taichung, South, 402 Recruiting
Chin-Lin Hsu Professor, 04-24730022 Ext. 12222, clhsu@csmu.edu.tw
About this study
This study aims to investigate the effects of RT-90 resistant cassava starch on glycemic control using a human dietary trial and to evaluate its potential as a prebiotic fiber supplement. This study will assess the efficacy of RT-90 resistant cassava starch in improving glycemic control, body composition, and gut microbiome in healthy individuals.
Read the detailed description
This study consisted of two phases.
The first phase was conducted in a randomized, cross-controlled manner. Before entering the study, participants maintained a normal diet and lifestyle for three consecutive days. Afterward, they entered the study and underwent a resistant starch assessment until the end of the study. Forty participants were randomly divided into two groups: 20 in each of the Weidan resistant starch group and the glucose powder group. Weidan resistant starch consists of tapioca resistant starch and glucose powder. Both groups consumed the sample within 5 minutes and then underwent an oral glucose tolerance test (OGTT). The participants fasted for 8-12 hours the day before the test (water was permitted). Blood samples (1 mL each) were collected at 0, 30, 60, 90, 120, and 180 minutes to monitor blood glucose levels. After the study, the two groups consumed either Weidan resistant starch or 50 g of glucose powder, each containing 50 g of total carbohydrates (57 g total product weight), dissolved in 250 mL of water, within 5 minutes, at least one week after the study. Blood glucose levels were monitored. After the study, the two groups alternated and consumed Weidan resistant starch or glucose powder again, followed by an oral glucose tolerance test and body composition measurements using the Inbody270 body composition analyzer.
The second phase of the study was conducted in a randomized, double-blind, placebo-controlled manner. Prior to entering the study, participants maintained a normal diet and lifestyle for three consecutive days. Afterward, they entered the study and underwent resistant starch assessment until completion. 75 subjects were randomly divided into three groups: the Weidan resistant starch group, the commercial resistant starch group, and the placebo control group. The ingredients of Weidan resistant starch are cassava resistant starch; the ingredients of commercial resistant starch are wheat resistant starch; and the placebo control group are natural cassava starch. The dosage is calculated based on 0.5 grams per kilogram of adult body weight (for example, a 60-kilogram adult needs to take 30 grams). The subjects were required to dissolve the test product in water and drink it on an empty stomach before their first meal each day for 12 weeks. The evaluation items at each follow-up visit included: (1) general physical examination (mental state, sleep, appetite, gastrointestinal symptoms, blood pressure, pulse and respiratory rate), (2) body measurement and body composition analysis (weight, BMI, waist circumference, hip circumference, subcutaneous fat thickness, skeletal muscle weight, body fat percentage and total water weight), (3) routine blood and biochemical examination, including red blood cell and white blood cell count, hemoglobin, hematocrit, mean corpuscular volume and platelets, renal function (urea nitrogen, creatinine, uric acid), thyroid hormone, liver function (AST, ALT, γ-GT and albumin), blood lipids (triglycerides, total cholesterol, free fatty acids, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), electrolyte balance (sodium, potassium, chloride, phosphorus, calcium) and fasting blood glucose (blood volume was 15 mL, must fast for at least 8 hours), (4) diet and activity records (including 24-hour diet review and weekly gastrointestinal function symptom records), (5) analysis of intestinal related indicators, including short-chain fatty acids (SCFA) and intestinal flora (NGS). Samples were collected and analyzed at week 0 and week 12.
- Conditions
- Resistant Starch, Tapioca Starch, Prebiotic Fiber, Blood Sugar
- Being tested
- RT-90 resistant tapioca starch, control group, Commercially available resistant starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-90 resistant tapioca starchDietary supplement
Within 5 minutes, consume resistant starch containing 50 g of total carbohydrates (total product weight 57 g), dissolved in 250 mL of water, and perform an oral glucose tolerance test to monitor blood sugar changes. After the test, the two groups will switch and consume resistant starch or glucose powder again after at least 1 week.
control groupDietary supplement
The subjects were asked to take a 50 g glucose powder dissolved in 250 mL of water within 5 minutes to conduct an oral glucose tolerance test to monitor blood sugar changes. After the test, the subjects were asked to empty their stomachs at least 1 week after the test and then switch to take RT-90 resistant starch or glucose powder again.
Commercially available resistant starchDietary supplement
The dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Participants should dissolve the test product in water and drink it on an empty stomach before their first meal each day, continuing for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| RT-90 resistant tapioca starch | Experimental | Phase 1： Equivalent to 50 g total carbohydrates (57 g total product weight) of resistant starch dissolved in 250 mL of water Phase 2： The dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Subjects should dissolve the test product in water and drink it on an empty stomach before their first meal of the day. Receives: Dietary Supplement: RT-90 resistant tapioca starch |
| control group | Placebo comparator | Phase 1：50g glucose powder, dissolved in 250 mL of water
Phase 2：The dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Participants should dissolve the test product in water and drink it on an empty stomach before their first meal each day, continuing for 12 weeks. Receives: Dietary Supplement: control group |
| Commercially available resistant starch | Active comparator | The dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Subjects should dissolve the test product in water and drink it on an empty stomach before their first meal of the day. Receives: Dietary Supplement: Commercially available resistant starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Trial Changes in Fasting Blood Glucose from Baseline to End of Trial (Glycemic Index Test Phase)
Fasting blood glucose levels were measured at baseline and at the completion of the glycemic index (GI) test phase to assess short-term glycemic response.
Blood Volume: 1 cc/times
Measured: Week 0 and 2
Phase 2 Changes from Baseline to End of Trial (Prebiotic Assessment)
Fasting blood glucose levels will be measured at baseline and 12 weeks after prebiotic supplementation to assess long-term metabolic response.
Blood Draw Volume: 15 mL/dose
Measured: Week 0 to12
Phase 2 Changes from Baseline to End of Trial (Prebiotic Assessment
Ftool samples will be collected at Week 0 and Week 12 to analyze gut microbiota diversity.
Measured: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant StarchStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The first phase of the study was cross-sectional; the second phase was parallel
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282496
- Sponsor's protocol ID
- CS2-25120
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of VEDAN RT-90 Resistant Cassava Starch for Glycemic Control and Prebiotic Fiber Development in a Human Trial
- ClinicalTrials.gov ID
- NCT07282496
- Acronym / sponsor ID
- CS2-25120
- Conditions
- Resistant Starch, Tapioca Starch, Prebiotic Fiber, Blood Sugar
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Dec 2025 (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 aims to investigate the effects of RT-90 resistant cassava starch on glycemic control using a human dietary trial and to evaluate its potential as a prebiotic fiber supplement. This study will assess the efficacy of RT-90 resistant cassava starch in improving glycemic control, body composition, and gut microbiome in healthy individuals.
Detailed description
This study consisted of two phases.
The first phase was conducted in a randomized, cross-controlled manner. Before entering the study, participants maintained a normal diet and lifestyle for three consecutive days. Afterward, they entered the study and underwent a resistant starch assessment until the end of the study. Forty participants were randomly divided into two groups: 20 in each of the Weidan resistant starch group and the glucose powder group. Weidan resistant starch consists of tapioca resistant starch and glucose powder. Both groups consumed the sample within 5 minutes and then underwent an oral glucose tolerance test (OGTT). The participants fasted for 8-12 hours the day before the test (water was permitted). Blood samples (1 mL each) were collected at 0, 30, 60, 90, 120, and 180 minutes to monitor blood glucose levels. After the study, the two groups consumed either Weidan resistant starch or 50 g of glucose powder, each containing 50 g of total carbohydrates (57 g total product weight), dissolved in 250 mL of water, within 5 minutes, at least one week after the study. Blood glucose levels were monitored. After the study, the two groups alternated and consumed Weidan resistant starch or glucose powder again, followed by an oral glucose tolerance test and body composition measurements using the Inbody270 body composition analyzer.
The second phase of the study was conducted in a randomized, double-blind, placebo-controlled manner. Prior to entering the study, participants maintained a normal diet and lifestyle for three consecutive days. Afterward, they entered the study and underwent resistant starch assessment until completion. 75 subjects were randomly divided into three groups: the Weidan resistant starch group, the commercial resistant starch group, and the placebo control group. The ingredients of Weidan resistant starch are cassava resistant starch; the ingredients of commercial resistant starch are wheat resistant starch; and the placebo control group are natural cassava starch. The dosage is calculated based on 0.5 grams per kilogram of adult body weight (for example, a 60-kilogram adult needs to take 30 grams). The subjects were required to dissolve the test product in water and drink it on an empty stomach before their first meal each day for 12 weeks. The evaluation items at each follow-up visit included: (1) general physical examination (mental state, sleep, appetite, gastrointestinal symptoms, blood pressure, pulse and respiratory rate), (2) body measurement and body composition analysis (weight, BMI, waist circumference, hip circumference, subcutaneous fat thickness, skeletal muscle weight, body fat percentage and total water weight), (3) routine blood and biochemical examination, including red blood cell and white blood cell count, hemoglobin, hematocrit, mean corpuscular volume and platelets, renal function (urea nitrogen, creatinine, uric acid), thyroid hormone, liver function (AST, ALT, γ-GT and albumin), blood lipids (triglycerides, total cholesterol, free fatty acids, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), electrolyte balance (sodium, potassium, chloride, phosphorus, calcium) and fasting blood glucose (blood volume was 15 mL, must fast for at least 8 hours), (4) diet and activity records (including 24-hour diet review and weekly gastrointestinal function symptom records), (5) analysis of intestinal related indicators, including short-chain fatty acids (SCFA) and intestinal flora (NGS). Samples were collected and analyzed at week 0 and week 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- The first phase of the study was cross-sectional; the second phase was parallel
| Arm | Type | Receives |
|---|---|---|
| RT-90 resistant tapioca starch | Experimental | Dietary Supplement: RT-90 resistant tapioca starchPhase 1： Equivalent to 50 g total carbohydrates (57 g total product weight) of resistant starch dissolved in 250 mL of water Phase 2： The dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Subjects should dissolve the test product in water and drink it on an empty stomach before their first meal of the day. |
| control group | Placebo comparator | Dietary Supplement: control groupPhase 1：50g glucose powder, dissolved in 250 mL of water Phase 2：The dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Participants should dissolve the test product in water and drink it on an empty stomach before their first meal each day, continuing for 12 weeks. |
| Commercially available resistant starch | Active comparator | Dietary Supplement: Commercially available resistant starchThe dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Subjects should dissolve the test product in water and drink it on an empty stomach before their first meal of the day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18-65 years.
- Healthy subjects (BMI between 18.5-24.9 kg/m² for women and men).
- Subjects must be able to maintain a stable diet (based on the Ministry of Health and Welfare's daily dietary guidelines, with a tolerance of ± 10-15%) and physical activity (based on the World Health Organization's recommendations of 150-300 minutes of moderate-intensity exercise per week, or equivalent physical activity, with a tolerance of ± 20%) during the trial period.
- Subjects must understand the trial procedures and potential risks and benefits described in the consent form and be able to sign the consent form.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women.
- Subjects with endocrine abnormalities, major organ disease, or mental illness (as determined by a physician).
- Subjects found to be intolerant to the test sample during the trial.
- Subjects who develop a disease or take medications or health supplements that could affect the results of the trial during the trial period. (e.g., hypoglycemic (lipid)-lowering medications, probiotics, high-dose dietary fiber supplements, fish oil, or supplements high in polyunsaturated fatty acids).
- Chronic gastrointestinal diseases (e.g., diverticular disease, irritable bowel syndrome, or other intestinal diseases that may cause constipation).
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 |
|---|---|---|
| RT-90 resistant tapioca starchWithin 5 minutes, consume resistant starch containing 50 g of total carbohydrates (total product weight 57 g), dissolved in 250 mL of water, and perform an oral glucose tolerance test to monitor blood sugar changes. After the test, the two groups will switch and consume resistant starch or glucose powder again after at least 1 week. | Dietary supplement | RT-90 resistant tapioca starch |
| control groupThe subjects were asked to take a 50 g glucose powder dissolved in 250 mL of water within 5 minutes to conduct an oral glucose tolerance test to monitor blood sugar changes. After the test, the subjects were asked to empty their stomachs at least 1 week after the test and then switch to take RT-90 resistant starch or glucose powder again. | Dietary supplement | control group |
| Commercially available resistant starchThe dosage is calculated at 0.5 grams per kilogram of adult body weight (e.g., a 60-kilogram adult would need to take 30 grams). Participants should dissolve the test product in water and drink it on an empty stomach before their first meal each day, continuing for 12 weeks. | Dietary supplement | Commercially available resistant starch |
Primary outcome
Phase 1 Trial Changes in Fasting Blood Glucose from Baseline to End of Trial (Glycemic Index Test Phase)
Time frame: Week 0 and 2
Fasting blood glucose levels were measured at baseline and at the completion of the glycemic index (GI) test phase to assess short-term glycemic response. Blood Volume: 1 cc/times
Phase 2 Changes from Baseline to End of Trial (Prebiotic Assessment)
Time frame: Week 0 to12
Fasting blood glucose levels will be measured at baseline and 12 weeks after prebiotic supplementation to assess long-term metabolic response. Blood Draw Volume: 15 mL/dose
Phase 2 Changes from Baseline to End of Trial (Prebiotic Assessment
Time frame: Week 0 and Week 12
Ftool samples will be collected at Week 0 and Week 12 to analyze gut microbiota diversity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Related trials for Resistant Starch
Recruiting
Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits
Fasting, Dietary Fibre
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
RecruitingPhase 2
Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Allogeneic Stem Cell Transplant
RecruitingPhase 2
Combined Oral Contraceptive Pill and Resistance Starch
Metabolic Syndrome, Polycystic Ovary Syndrome
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-90 resistant tapioca starch and Commercially available resistant starch in people with Resistant Starch and Tapioca Starch, run by Chung Shan Medical University at 1 site in Taiwan.
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 6 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: opening soon, as of the sponsor's last update on 15 Dec 2025. 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 Taiwan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin-Lin Professor (04-24730022 Ext. 12222, clhsu@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Trial Changes in Fasting Blood Glucose from Baseline to End of Trial (Glycemic Index Test Phase) (time frame: Week 0 and 2). The study lists 3 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 15 Dec 2025.