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.
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.
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).
Crossover
RT-90 resistant tapioca starch
Dietary supplementWithin 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 group
Dietary supplementThe 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 starch
Dietary supplementThe 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.
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
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
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.
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