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Retinal Microcirculation DisorderNCT03416088

Influence of Daily Activities on Retinal Microcirculation

A study testing Beverage consumption, Daily reading and Body motion in people with Retinal Microcirculation Disorder, run by Jiannan Huang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Retinal Microcirculation Disorder
What is being tested?
Beverage consumption, Daily reading and Body motion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
1 May 2017to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Eye Disease Prevention & Treatment Center

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: The Influence of Daily Activities on Retinal Microcirculation in Normal Adults

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.

Being tested
Beverage consumption, Daily reading, Body motion
Keywords
Beverage consumption, Reading, Body motion, Retinal microcirculation, Optical coherence tomography angiography, Magnetic resonance imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beverage consumptionBehavioural

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

  • Daily readingBehavioural

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

  • Body motionBehavioural

    Exercise or body postural changes

Study groups in NCT03416088
Study groupRoleWhat they receive
Beverage consumptionExperimentalDrink 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.
Receives: Behavioral: Beverage consumption
Daily readingExperimentalReading paper books, playing video games with mobile phones, or non-reading.
Receives: Behavioral: Daily reading
Body motionExperimentalExercise and body postural changes.
Receives: Behavioral: Body motion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vessel diameter index (VDI)

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

    Measured: 3 weeks

  2. 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.

    Measured: 3 weeks

  3. Flow impairment region (FIR)

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

    Measured: 3 weeks

  4. 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.

    Measured: 3 weeks

  5. Cerebral blood flow (CBF)

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

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start1 May 2017
  3. Primary completion31 Oct 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416088
Sponsor's protocol ID
YFZX2017001
Status last verified
Apr 2025
First submitted
17 Jan 2018
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant data because of personal privacy.

Publications

  • 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.

    PubMed 23934579

  • 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.

    PubMed 21343207

  • 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.

    PubMed 29044670

  • 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.

    PubMed 29401177

  • 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.

    PubMed 19523476

  • 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.

    PubMed 25110231

  • 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.

    PubMed 10913661

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

    PubMed 29358250

Questions about this trial

What is this clinical trial studying?

A study testing Beverage consumption, Daily reading and Body motion in people with Retinal Microcirculation Disorder, run by Jiannan Huang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vessel diameter index (VDI) (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03416088, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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