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The Study of Glycemic Index of GEN-DM modified formula

The Study of Glycemic Index of GEN-DM MF

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230922003
Enrollment
10
Registered
2023-09-22
Start date
2023-03-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study would like to calculate glycemic index of Gen-DM MF by examination of blood glucose in healthy volunteers. Glycemic Index (GI), Low glycemic Index formulation supplement, Gen-DM MF

Interventions

The first visit, after at least 10 hours fasting, subject will be take 50 g glucose within 5 minutes and subject&#039
s blood will be collect at 0, 30, 60, 90 and 120 minutes. The second visit, after at least 10 hours fasting, subject will be take Gen-DM MF 84.46 g within 5 minutes and subject&#039
s blood will be collect at 0, 30, 60, 90 and 120 minutes.
Experimental Dietary Supplement
Low glycemic Index formulation supplement

Sponsors

Thai Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Able to obtain inform consent form patients or his/her legal representative 2.Patients of both sexes who are at least 18 years old 3.Body Mass Index is 18.5 - 24.9 kg/m2 4.Heathy volunteer 5.No Smoking, alcohol drinking, drugs and substance Abuse 6.Oral Glucose Tolerance Test lower than 140 mg/dL

Exclusion criteria

Exclusion criteria: 1.Having family history or diagnosed with Diabetes Mellitus. 2.Taking insulin or glucose-lowering medication within 1 month previous joining this study. 3.Allergic to components of study formula . 4.Having history or diagnosed with Diabetes Mellitus, Hypertension, Cardiovascular disease, Chronic liver disease, chronic kidney disease, Thyroid disease, Maldigestion and Malabsorption. 5.Taking other study investigated product, medical food or vitamins within 7 days previous joining this study. 6.Not able to following the study protocol.

Design outcomes

Primary

MeasureTime frame
Glycemic index 0, 30, 60, 90 and 120 minutes Calculated by the ratio of AUC(blood glucose of GEN-DM MF) to AUC(blood glucose of glucose) and multiplied by 100

Secondary

MeasureTime frame
blood glucose 0, 30, 60, 90 and 120 minutes Blood collection

Countries

Thailand

Contacts

Public ContactPannatorn Panyapalungkul

Thai Otsuka Pharmaceutical Co., Ltd.

pannatorn@thai-otsuka.co.th660655173735

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026