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A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of poly-gamma-glutamic acid(0.15g/day) on reducing serum triglycerides of male and female adults(200mg/dl<= serum triglycerides <500mg/dl)

A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of poly-gamma-glutamic acid(0.15g/day) on reducing serum triglycerides of male and female adults(200mg/dl<= serum triglycerides <500mg/dl)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0000339
Enrollment
80
Registered
2012-02-03
Start date
2012-02-06
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 : Subjects will be randomly assigned to receive Poly-?-glutamic acid(?-PGA) 0.15g or placebo. Subjets will orally self-adminster Poly-?-glutamic acid(?-PGA) 0.15g or placebo qd, for

Sponsors

Inje University Seoul Paik Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male and female subjects of 200mg/dl -500mg/dl in serum triglycerides 2) Male and female subjects between 19-65 years old 3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

Exclusion criteria

Exclusion criteria: 1. Subjects who took a drug(total-cholesterol treatment) within 3 months 2. Subjects with hyperlipidemia who need a drug treatment 3. Subjects with cardiovascular disorder 4. Subjects who use of antiobestic drug 5. Subjects who use of beta blocker or hydragogue 6. Subjects with diabetes (fasting blood glucose 126= or random blood glucose =200, and also use of hypoglycemic agent or insulin) 7. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10uU/ml) 8. Subjects with serum AST/ALT = 3 times the upper limit of normal 9. Subjects with severe gastrointestinal symptom(heartburn, indigestion) 10. Subjects who drinks alcohol 4 times per a week 11. Subjects with disease of gallbladder, gastrointestinal, gout, porphyria 12. Subjects with a history of CNS disorder(depressivedisorder,schizophrenia, alcoholism, drug addiction ) 13. Subjects with malnutrition 14. Woman who are pregnant or lactating 15. Subjects who have a plan to participate in other clinical trial 16. Subjects who took part in other clinical trial within 3 months 17. Subjects which in the opinion investigator could affect preclude evauation of response

Design outcomes

Primary

MeasureTime frame
Serum triglyceride

Secondary

MeasureTime frame
Weight;BMI(Body mass index);Serum Total-cholesterol

Countries

Korea, Republic of

Contacts

Public ContactYangim Hur

Inje University Seoul Paik Hospital

Outcome results

None listed

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