Clinical trial NCT02321189: The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness
Official title: The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Disease
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 34
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Choroidal Thickness(micrometer)
timeFrame: baseline
Secondary outcomes:
measure: Choroidal Thickness(micrometer)
timeFrame: 1 hour after baseline
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Medical College of HUST
state: Hubei
Study officials:
affiliation: Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology
name: Xunfang Sun
role: STUDY_DIRECTOR
References: