NCT03416088

Brief Summary

The daily behaviors such as drinking coffee, wine, reading, exercise and body postural changes may have influence on the function or morphology of the retinal microcirculation in healthy people.A recent study found that the fingertips microvascular bed constricted obviously after the intake of a cup of coffee with caffeine, it significantly reduced blood flow to the fingers; Long reading of electronic products can induce significant dry eye symptoms, affect visual quality, and cause asthenopia. Microcirculation is critical for regulating vascular resistance and blood flow in organs. Fundus blood vessels is the only visible microvascular in vivo, its morphology and function changes not only associated with eye disease, but also with cardiovascular and cerebrovascular diseases. Optical coherence tomography angiography (OCTA) is a new technique which could acquire blood flow information in a non-invasive way without the use of dye. Magnetic resonance imaging (MRI) can quantitatively evaluation of cerebral blood flow and retina-choroid blood flow using the noninvasive arterial spin labeling technique in a large field of view (FOV) without depth limitations.The study tried to detect the influence of daily behaviors such as drinking coffee, red wine, reading , exercise, etc. on the retinal microcirculation with OCTA and MRI, and provide reference for health behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

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

May 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

3.5 years

First QC Date

January 17, 2018

Last Update Submit

April 13, 2025

Conditions

Keywords

Beverage consumptionReadingBody motionRetinal microcirculationOptical coherence tomography angiographyMagnetic resonance imaging

Outcome Measures

Primary Outcomes (5)

  • Vessel diameter index (VDI)

    VDI is calculated using both the vessel area map and the skeletonized vessel map, to yield the averaged vessel caliber.

    3 weeks

  • Vessel area density (VAD)

    VAD is calculated as a unit-less ratio of the total image area occupied by the vasculature to the total image area in the binary vessel maps.

    3 weeks

  • Flow impairment region (FIR)

    FIZ: calculated by summing all 'no-flow' pixels up.

    3 weeks

  • Retina-choroid blood flow

    Blood flow for the entire retinal thickness were determined as a function of the distance from the optic nerve head, where the blood flow was measured at the peaks of the projection profiles. An region of interest outlining the posterior retina with a size of 0.7 to 0.8 mm across the retina-choroid thickness in the parafoveal region was used to obtain the blood flow signal time courses and averaged the values.

    3 weeks

  • Cerebral blood flow (CBF)

    The frontal lobe was selected as the region of interest (ROI) to measure and average the changes in CBF

    3 weeks

Study Arms (3)

Beverage consumption

EXPERIMENTAL

Drink 300ml red wine (alcohol concentration:12.5%), 300ml coffee (caffeine concentration 72 mg), 300 ml Baijiu (Chinese liquor, alcohol concentration:12.5%) , SipSparkTM Probiotics (facilitates ethanol degradation) was taken 0.5 hour prior to Baijiu consumption, or 300ml water.

Behavioral: Beverage consumption

Daily reading

EXPERIMENTAL

Reading paper books, playing video games with mobile phones, or non-reading.

Behavioral: Daily reading

Body motion

EXPERIMENTAL

Exercise and body postural changes.

Behavioral: Body motion

Interventions

The participants drink 300ml wine (alcohol concentration:12.5%)or 300ml coffee (caffeine concentration 72 mg), or water.

Beverage consumption
Daily readingBEHAVIORAL

Reading paper books, playing video games with mobile phones, or non-reading for 8 hours.

Daily reading
Body motionBEHAVIORAL

Exercise or body postural changes

Body motion

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults
  • The age range was from 18 to 35 years old
  • Without another eye disease besides ametropia
  • The spherical equivalent is equal or above minus 3.00 diopters
  • No smoking or drinking
  • Average daily caffeine consumption no more than 1 cup of coffee
  • No diabetes, hypertension, heart disease, liver or kidney dysfunction
  • No medication taken recently

You may not qualify if:

  • Mental disorders such as depression and anxiety
  • Intellectual disabilities
  • Female in menstruation, gestation period, perinatal period or lactation period
  • Unable to cooperate with eye examinations and test procedures
  • Heart disease, hypertension, diabetes, liver and kidney dysfunction and other chronic diseases
  • Patients with fever, acute infectious diseases
  • Other conditions that are not suitable for drinking alcohol or coffee, such as allergic to alcohol or coffee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (8)

  • Malerba S, Turati F, Galeone C, Pelucchi C, Verga F, La Vecchia C, Tavani A. A meta-analysis of prospective studies of coffee consumption and mortality for all causes, cancers and cardiovascular diseases. Eur J Epidemiol. 2013 Jul;28(7):527-39. doi: 10.1007/s10654-013-9834-7. Epub 2013 Aug 11.

    PMID: 23934579BACKGROUND
  • Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA. Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis. BMJ. 2011 Feb 22;342:d671. doi: 10.1136/bmj.d671.

    PMID: 21343207BACKGROUND
  • Lawrenson JG, Hull CC, Downie LE. The effect of blue-light blocking spectacle lenses on visual performance, macular health and the sleep-wake cycle: a systematic review of the literature. Ophthalmic Physiol Opt. 2017 Nov;37(6):644-654. doi: 10.1111/opo.12406.

    PMID: 29044670BACKGROUND
  • Karti O, Zengin MO, Kerci SG, Ayhan Z, Kusbeci T. ACUTE EFFECT OF CAFFEINE ON MACULAR MICROCIRCULATION IN HEALTHY SUBJECTS: An Optical Coherence Tomography Angiography Study. Retina. 2019 May;39(5):964-971. doi: 10.1097/IAE.0000000000002058.

  • Luksch A, Resch H, Weigert G, Sacu S, Schmetterer L, Garhofer G. Acute effects of intravenously administered ethanol on retinal vessel diameters and flicker induced vasodilatation in healthy volunteers. Microvasc Res. 2009 Sep;78(2):224-9. doi: 10.1016/j.mvr.2009.06.001. Epub 2009 Jun 10.

  • Strang NM, Claus ED, Ramchandani VA, Graff-Guerrero A, Boileau I, Hendershot CS. Dose-dependent effects of intravenous alcohol administration on cerebral blood flow in young adults. Psychopharmacology (Berl). 2015 Feb;232(4):733-44. doi: 10.1007/s00213-014-3706-z. Epub 2014 Aug 12.

  • Kojima S, Sugiyama T, Kojima M, Azuma I I, Ito S. Effect of the consumption of ethanol on the microcirculation of the human optic nerve head in the acute phase. Jpn J Ophthalmol. 2000 May;44(3):318-9. doi: 10.1016/s0021-5155(00)00158-1.

  • Molnar F, Frank CC. Determining the causes of postural hypotension. Can Fam Physician. 2018 Jan;64(1):40. No abstract available.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analyzers are blind to the participants classification
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 1. Influence of beverage consumption Participants drink coffee, red wine, Baijiu (Chinese liquor), grape juice, and water respectively on three mornings with one-week washout. Each period lasts 2 hours. An additional test with SipSparkTM Probiotics (facilitates ethanol degradation) was taken 0.5 hour prior to Baijiu consumption. OCTA and MRI scanning are taken every 30 minutes, and venous blood is collected. 2. Influence of daily reading 30 participants read paper books, play video games with mobile phones, and non-read respectively on three mornings interval with one-week washout. OCTA and MRI scanning are taken every 2 hours for a total of 8 hours. 3. Influence of body motion Exercise: 30 participants are enrolled. Participants undergo to jogging for 10 minutes, 30 minutes, and 1 hour respectively on three mornings with a 3-day washout. Body postural changes: 30 participants are enrolled. OCTA and MRI scanning are taken before and after jogging or body postural changes.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 30, 2018

Study Start

May 1, 2017

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data because of personal privacy.

Locations