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A Randomized, Double-blind, Crossover Trial for evaluation of efficacy and single dose safety and of fermentated sorghum power on healthy human

A Randomized, Double-blind, Crossover Trial for evaluation of efficacy and single dose safety and of fermentated sorghum power on healthy human

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0000919
Enrollment
60
Registered
2013-11-12
Start date
2013-10-25
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Dietary Supplement : Sorghum-fermentation 500mg group or placebo group: once a day, and ingested 2 capsules before a meal.

Sponsors

Inje University Seoul Paik Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Male and female subjects between 20-65years of age inclusive 2)Fasting glucose or post-prandial 2 hour the normal range on screening. 3)Subjects who agree the particpation in the trial and sobmit informed and consent before the beginning of the trial.

Exclusion criteria

Exclusion criteria: 1)Subject who taking a health functional food that affect blood glucose within the 2 weeks prior to screening. 2)Subjects who taking a hypoglycemic agent within the 3 months prior to screening. 3)TSH value =0.1uU/ml or =10 uU/ml 4)Serum creatinine = 2 times the upper limit of normal. 5)Serum AST/ALT = 3 times the upper limit of normal. 6)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg. 7)Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia 8)Subjects who drinks alcohol 4 times per a week. 9)Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon. 10)Pregnant or possibility of pregnancy, or breast feeding mothers. 11)Designated persons who will take part in the other trial during this trial. 12)Inappropriate person decided by investigator. 13)Allergy or hypersensitivity in the sorghum.

Design outcomes

Primary

MeasureTime frame
2 hours postprandial blood glucose;0GTT, AUC(0~2hr);2 hours postprandial insulin

Secondary

MeasureTime frame
Abnormality reaction;Systolic BP, diastolic BP

Countries

Korea, Republic of

Contacts

Public ContactYun Choi

Inje University Seoul Paik Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026