NCT01634256

Brief Summary

The investigators performed a double-blind parallel study in a group of showing mild hepatic injury subjects who were given Fermented turmeric over a period of 12 weeks. The investigators measured liver function parameters , including ALT(Alanine Transaminase), AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and serum bilirubin, and monitored their blood pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

July 3, 2012

Results QC Date

July 11, 2012

Last Update Submit

September 4, 2012

Conditions

Mild Hepatic Injury

Outcome Measures

Primary Outcomes (1)

  • Changes in ALT(Alanine Transaminase)

    ALT was measured in study visit 1(0 week) and visit 3(12 week).

    12 weeks

Secondary Outcomes (4)

  • Changes in AST(Aspartate Transaminase)

    12 weeks

  • Changes in ALP(Alkaline Phosphatase)

    12 weeks

  • Changes in γ-GT(Gamma-Glutamyl Transferase)

    12 weeks

  • Changes in Serum Bilirubin

    12 weeks

Study Arms (2)

Fermented turmeric

EXPERIMENTAL
Dietary Supplement: Fermented turmeric

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo(3.0g/day)

Placebo
Fermented turmericDIETARY_SUPPLEMENT

Fermented turmeric(3.0g/day)

Fermented turmeric

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 19-70 years old
  • Mild hepatic injury as indicated by ALT(Alanine Transaminase) level ≥ 40
  • Able to give informed consent

You may not qualify if:

  • Allergy or hypersensitivity to any of the ingredients in the test products
  • History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • Carriers of viral hepatitis (type B and C)
  • History of underlying Esophageal varices, hepatic encephalopathy, ascites(past 12 months)
  • Participation in other clinical trials within the past 2 months
  • Patients with acute hepatitis (type B and C)
  • History of underlying cirrhosis and liver cancer
  • History of underlying biliary diseases such as jaundice or gallstones
  • History of underlying kidney disease such as Chronic renal failure or nephrotic syndrome
  • Pregnant, planning to become pregnant, or breast-feeding
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Related Publications (1)

  • Kim SW, Ha KC, Choi EK, Jung SY, Kim MG, Kwon DY, Yang HJ, Kim MJ, Kang HJ, Back HI, Kim SY, Park SH, Baek HY, Kim YJ, Lee JY, Chae SW. The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study. BMC Complement Altern Med. 2013 Mar 8;13:58. doi: 10.1186/1472-6882-13-58.

    PMID: 23497020DERIVED

Results Point of Contact

Title
Dr. Sang-Wook Kim, MD
Organization
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
clickm@jbnu.ac.kr
82-63-276-8284

Study Officials

  • Sang-Wook Kim, MS

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

October 4, 2012

Results First Posted

October 4, 2012

Record last verified: 2012-09

Locations

KR(1)