NCT02019368

Brief Summary

This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

December 18, 2013

Last Update Submit

August 17, 2015

Conditions

Heavy Smoker or Non-smoker

Outcome Measures

Primary Outcomes (1)

  • Urinary 8-hydroxydeoxyguanosine (8-OHdG)

    Every 4 weeks (Overall 12 weeks)

Secondary Outcomes (3)

  • High sensitive CRP

    Every 4 weeks (Overall 12 weeks)

  • Blood pressure

    Every 4 weeks (Overall 12 weeks)

  • Indices of the second derivative of photoplethysmogram (SDPTG)

    Every 4 weeks (Overall 12 weeks)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Smoker subjects take 6 capsules once a day for 4 weeks.

Dietary Supplement: Placebo

Aged garlic extract

EXPERIMENTAL

Smoker subjects take 1.5 g of aged garlic extract in 6 capsules once a day for 4 weeks.

Dietary Supplement: Aged garlic extract

Non-smoker

NO INTERVENTION

Oxidative status in non-smoker

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo
Aged garlic extractDIETARY_SUPPLEMENT
Aged garlic extract

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)

You may not qualify if:

  • Under medication for chronic disease
  • Garlic allergy
  • Engaging in vigorous exercise
  • Taking drugs or functional food that may possess antioxidant property
  • Participation in any clinical trial within 90 days of the commencement of the trial
  • Renal or hepatic dysfunction
  • Heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Hiroshima, 734-8551, Japan

Location

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 24, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

JP(1)