Effects of Green Tea Consumption on Primary Glaucoma

NCT06235827 | Recruiting

• 1 other identifier: RSCH ID-23-03868-NIT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomised control trial is to learn about the effect of green tea consumption on patients with primary glaucoma. The main questions to answer are:

1. 1.Is there any difference of intraocular pressure (IOP) in patient with primary glaucoma after 1 month, 3 months and 6 months who is consuming green tea compared to patient not consuming green tea?
2. 2.Is there any difference of retina nerve fibre layer in patient with primary glaucoma after 1 month, 3months and 6 months who is consuming green tea compared to patient not consuming green tea?

Conditions

Primary Glaucoma

Outcome Measures

Primary Outcomes (2)

• Effect of green tea consumption on intraocular pressure in patient with primary glaucoma

  IOP measurement will be done using Goldmann Applanation Tonometer (GAT) for group A and Group B

  IOP measurement will be taken at baseline, first, and 6th-month post recruitment for group A and B.

• Effect of green tea consumption on retinal nerve fiber layer thickness ( RNFL) in patient with primary glaucoma

  Spectral domain Heidelberg Spectralis OCT will be used to measure RNFL thickness

  OCT RNFL will be conducted at baseline, 1 month, 3 month and 6 month post recruitment for group A and B.

Study Arms (2)

Green tea group

EXPERIMENTAL

Patients in Group A will have to consume two cup (250ml for each cup) of hot green tea, five days per week for 6 months. A tea bag is brewed in 250ml hot water for 3 minutes.

Dietary Supplement: Green tean group

Control Group

EXPERIMENTAL

Patients in Group B will not consume green tea for 6 months during study period.

Dietary Supplement: Control group

Interventions

Green tean group DIETARY_SUPPLEMENT

Patients in Group A will have to consume two cups (250ml for each cup) of hot green tea, five days per week for 6 months. A tea bag is brewed in 250ml hot water for 3 minutes. They are only allowed to consume as hot drink, not for iced tea. Any sweetener or sugar is not allowed to mix in the drink. The green tea bag will be distributed to patient at beginning of research and at every visit. Patient will be reminded weekly using text messages or phone call by a research assistant for green tea consumption.

Green tea group

Control group DIETARY_SUPPLEMENT

Patients in Group B will not be consuming green tea during 6 months of study period.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with confirmed diagnosis of primary glaucoma (POAG/PACG/NTG) that achieve target IOP with medical therapy at least for 6 months.
• Never consume green tea as daily drinks.

You may not qualify if:

• Dense cataract with Lens Opacity Classification Sytem (LOCS II) of more than grade 2
• Any other ocular media opacity that may interfere with OCT imaging ( eg: cornea scar/vitreous haemorrhage)
• Any history of optic neuropathy
• History of glaucoma or retinal surgery
• Macular degeneration and retinal disorder
• Patient with caffein sensitive that causes unpleasant reaction (eg: palpitation, insomnia, nausea, constipation)
• Allergic to green tea

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Hospital Universiti Sains Malaysia: collaborator

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (12)

• Braakhuis A, Raman R, Vaghefi E. The Association between Dietary Intake of Antioxidants and Ocular Disease. Diseases. 2017 Jan 30;5(1):3. doi: 10.3390/diseases5010003.

  PMID: 28933356 BACKGROUND

• Chu KO, Chan KP, Wang CC, Chu CY, Li WY, Choy KW, Rogers MS, Pang CP. Green tea catechins and their oxidative protection in the rat eye. J Agric Food Chem. 2010 Feb 10;58(3):1523-34. doi: 10.1021/jf9032602.

  PMID: 20085274 BACKGROUND

• Henning SM, Fajardo-Lira C, Lee HW, Youssefian AA, Go VL, Heber D. Catechin content of 18 teas and a green tea extract supplement correlates with the antioxidant capacity. Nutr Cancer. 2003;45(2):226-35. doi: 10.1207/S15327914NC4502_13.

  PMID: 12881018 BACKGROUND

• Hu J, Webster D, Cao J, Shao A. The safety of green tea and green tea extract consumption in adults - Results of a systematic review. Regul Toxicol Pharmacol. 2018 Jun;95:412-433. doi: 10.1016/j.yrtph.2018.03.019. Epub 2018 Mar 24.

  PMID: 29580974 BACKGROUND

• Chen JZ, Kadlubar FF. A new clue to glaucoma pathogenesis. Am J Med. 2003 Jun 1;114(8):697-8. doi: 10.1016/s0002-9343(03)00199-2. No abstract available.

  PMID: 12798460 BACKGROUND

• Kang JH, Ivey KL, Boumenna T, Rosner B, Wiggs JL, Pasquale LR. Prospective study of flavonoid intake and risk of primary open-angle glaucoma. Acta Ophthalmol. 2018 Sep;96(6):e692-e700. doi: 10.1111/aos.13705. Epub 2018 Mar 14.

  PMID: 29536641 BACKGROUND

• Calandrella N, De Seta C, Scarsella G, Risuleo G. Carnitine reduces the lipoperoxidative damage of the membrane and apoptosis after induction of cell stress in experimental glaucoma. Cell Death Dis. 2010 Aug 5;1(8):e62. doi: 10.1038/cddis.2010.40.

  PMID: 21364667 BACKGROUND

• Mousa A, Kondkar AA, Al-Obeidan SA, Azad TA, Sultan T, Osman E, Abu-Amero KK. Association of total antioxidants level with glaucoma type and severity. Saudi Med J. 2015 Jun;36(6):671-7. doi: 10.15537/smj.2015.6.10697.

  PMID: 25987108 BACKGROUND

• Yang Y, Xu C, Chen Y, Liang JJ, Xu Y, Chen SL, Huang S, Yang Q, Cen LP, Pang CP, Sun XH, Ng TK. Green Tea Extract Ameliorates Ischemia-Induced Retinal Ganglion Cell Degeneration in Rats. Oxid Med Cell Longev. 2019 Jul 9;2019:8407206. doi: 10.1155/2019/8407206. eCollection 2019.

  PMID: 31379990 BACKGROUND

• Falsini B, Marangoni D, Salgarello T, Stifano G, Montrone L, Di Landro S, Guccione L, Balestrazzi E, Colotto A. Effect of epigallocatechin-gallate on inner retinal function in ocular hypertension and glaucoma: a short-term study by pattern electroretinogram. Graefes Arch Clin Exp Ophthalmol. 2009 Sep;247(9):1223-33. doi: 10.1007/s00417-009-1064-z. Epub 2009 Mar 17.

  PMID: 19290537 BACKGROUND

• Gasiunas K, Galgauskas S. Green tea-a new perspective of glaucoma prevention. Int J Ophthalmol. 2022 May 18;15(5):747-752. doi: 10.18240/ijo.2022.05.09. eCollection 2022.

  PMID: 35601179 BACKGROUND

• Bernatoniene J, Kopustinskiene DM. The Role of Catechins in Cellular Responses to Oxidative Stress. Molecules. 2018 Apr 20;23(4):965. doi: 10.3390/molecules23040965.

  PMID: 29677167 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dr. Siti Sarah Shokri

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Siti Sarah Shokri, MBBS

CONTACT

+6017-4588381; sarahshokri88@gmail.com

Mr. Mohd Bazlan Hafidz Mukrim

CONTACT

09-767 2354 / 09-767 2362; bazlan@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)