8 weeks, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Olive leaf extract 1,000mg on reducing body weight and body fat of obese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000931

Enrollment

120

Registered

2013-11-19

Start date

2013-12-12

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 olive leaf extract 1,000mg or placebo. Subjets will orally self-adminster olive leaf extract 1,000mg or placebo group, for 8weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ) Male and female subjects between 20-65years of age inclusive. 2) BMI of 26.0-29.9kg/m2 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 with systolic BP 160> or diastolic BP 100>mmHg or use of beta blocker or hydragogue 2. Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose 126= or random blood glucose =200 3. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10uU/ml) 4. Serum AST/ALT = 3times the the upper limit of normal 5. Serum creatinine = 2times the the upper limit of normal 6. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon. 7. Subjets with clinically significant cardiovascular disease within the 6months prior to screening 8. Subjets with a history of cancer and inetrvention within the 5 years prior to screening. 9. Subjects with a history of CNS disorder(depressivedisorder,schizophrenia, alcoholism, drug addiction ) 10. Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period 11. Woman who are pregnant or lactating. 12. Participation in any clinical trial within the 3 months prior to screening. 13. Subjects who change weight over 10 percent within 3 months. 14.Subjects with the musculoskeletal system disorder or restricted physical activity 15. Subjects which in the opinion investigator could affect preclude evauation of response.

Design outcomes

Primary

Measure	Time frame
Body weight	—

Secondary

Measure	Time frame
Fat percentage, fatmass (by DEXA) ;Change in veceral fat (by CT) ;Change in waist circumference	—

Countries

Korea, Republic of

Contacts

Public ContactIN SUN JEONG

Inje University Seoul Paik Hospital

Outcome results