The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT02321189

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal thickness of the young participant using SD-OCT to see the effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness.

Condition or Disease	Intervention/Treatment	Phase
Eye Disease	Drug: LONGEVINEX Drug: placebo	N/A

Detailed Description

34 young, healthy participants were included in this study; They were randomly divided into two groups by age and gender matched.100 mg Longevinex® capsule was given to the study group and 100mg placebo capsule to the control group. All participants underwent OCT scanning with spectral domain optic coherence tomography (SD-OCT) at baseline and 1 h following Longevinex® or placebo administration. The choroidal thickness was measured manually by the Heidelberg Eye explore software(version 5.3.3.0, Heidelberg Engineering) with a vertical line to the retinal pigment epithelial layer.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: LONGEVINEX The Effect of LONGEVINEX on Choroidal Thickness	Drug: LONGEVINEX let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX
Placebo Comparator: placebo The Effect of placebo on Choroidal Thickness	Drug: placebo let everyone of the participants oral 1 capsule containing 100 mg placebo

Arm

Intervention/Treatment

Placebo Comparator: LONGEVINEX

The Effect of LONGEVINEX on Choroidal Thickness

Drug: LONGEVINEX

let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX

Placebo Comparator: placebo

The Effect of placebo on Choroidal Thickness

Drug: placebo

let everyone of the participants oral 1 capsule containing 100 mg placebo

Outcome Measures

Primary Outcome Measures

Choroidal Thickness(micrometer) [baseline]
using Heidelberg Eye Explorer software to measure choroidal thickness of participants

Secondary Outcome Measures

Choroidal Thickness(micrometer) [1 hour after baseline]
using Heidelberg Eye Explorer software to measure choroidal thickness of participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 28 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and female patients 23-28 years of age. nonsmokers.
Patients were considered to be healthy on the basis of electrocardiogram (ECG), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis B, hepatitis C and HIV serology) performed at screening.
Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time.
patients should abstain from alcohol-containing beverages at least two days prior to and during the study.

Exclusion Criteria:

Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
Participation in another simultaneous medical investigation or trial Renal failure requiring dialysis or renal transplant or liver dysfunction History of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.
IOP over 30 mmHg.
Any previous retinal laser photocoagulation to the study eye in treatment naive. Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).
Intracapsular cataract extraction (posterior capsule needs to be present).
Aphakia or absence of the posterior capsule in the study eye, Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Medical College of HUST	Wuhan	Hubei	China

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

Study Director: Xunfang Sun, Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xufang Sun, study director, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT02321189

Other Study ID Numbers:

Sun3

First Posted:

Dec 22, 2014

Last Update Posted:

Apr 3, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Apr 3, 2015