Evaluation of VEDAN RT-90 Resistant Cassava Starch for Glycemic Control and Prebiotic Fiber Development in a Human Trial

NCT07282496 | Not Yet Recruiting

• 1 other identifier: CS2-25120
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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. This study will assess the efficacy of RT-90 resistant cassava starch in improving glycemic control, body composition, and gut microbiome in healthy individuals.

Conditions

Resistant Starch; Tapioca Starch; Prebiotic Fiber; Blood Sugar

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  Week 0 and Week 12

Study Arms (3)

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.

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.

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.

Dietary Supplement: Commercially available resistant starch

Interventions

RT-90 resistant tapioca starch DIETARY_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.

RT-90 resistant tapioca starch

Commercially available resistant starch DIETARY_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.

Commercially available resistant starch

control group DIETARY_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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402 Recruiting, Taiwan

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Chin-Lin Professor

CONTACT

04-24730022 Ext. 12222; clhsu@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first phase of the study was cross-sectional; the second phase was parallel

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 15, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

TW (1)