The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

Eye Disease Clinical Trial

Official title:

The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321189
• Other study ID #: Sun3
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2014
• Last updated: April 2, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: Huazhong University of Science and Technology
• Contact: Shuaishuai Wang
• Phone: 15623422892
• Email: 949990624[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 28 Years

Eligibility

Inclusion Criteria:

1. Male and female patients 23-28 years of age. nonsmokers.

2. 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.

3. 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.

4. patients should abstain from alcohol-containing beverages at least two days prior to and during the study.

Exclusion Criteria:

1. Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus

2. 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.

3. IOP over 30 mmHg.

4. 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.

5. Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).

6. Intracapsular cataract extraction (posterior capsule needs to be present).

7. 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases

Intervention

Drug:
• LONGEVINEX
let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX
• placebo
let everyone of the participants oral 1 capsule containing 100 mg placebo

Locations

Country	Name	City	State
China	Tongji Medical College of HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal Thickness(micrometer)	using Heidelberg Eye Explorer software to measure choroidal thickness of participants	baseline	Yes
Secondary	Choroidal Thickness(micrometer)	using Heidelberg Eye Explorer software to measure choroidal thickness of participants	1 hour after baseline	Yes