NCT07687940

Brief Summary

Depression is a common mental health issue in older adults, often manifesting as insomnia, low mood, vague somatic complaints, cognitive decline, and recurrent thoughts of death or suicide. Even subthreshold depressive symptoms in late life significantly impair quality of life. In Hong Kong, recent data show high prevalence of depressive symptoms among community-dwelling older adults (43.7% in men, 54.8% in women), underscoring the urgent public health and economic need for effective interventions. Although the previous evidence has shown that BDJ and GT consumption can improve depressive symptoms, gut microbiota, and QoL respectively, the feasibility and effect of the combination of two intervention approaches in older adults remain unclear. Therefore, the proposed study aims to (1) determine the feasibility of a 12-week blended BDJ and GT consumption program among Hong Kong community-dwelling older adults with depressive symptoms in a small-scale sample, and (2) examine the effects of the blended BDJ and GT consumption program on their depressive symptoms, gut-microbiota and QoL compared with that in the active control group.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress50%
Nov 2025Apr 2027

Study Start

First participant enrolled

November 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

depressive symptomsolder adultsBaduanjin exercisegreen tea

Outcome Measures

Primary Outcomes (1)

  • Self-reported depressive symptoms

    The Chinese version of the 15-item Geriatric Depression Scale (GDS-C) will be used to measure the subjective depression level. The GDS are the most widely used scales for the detection of depression symptoms in older adults (Cronbach's α = .81 -.83).

    Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 12-weeks intervention (T2 post-intervention), and 3 months after intervention completion (T3 follow-up test).

Secondary Outcomes (2)

  • Gut-microbiota

    Evaluations of stool test will be performed three times at pre-intervention (T1), the 12-week (3-month) post-intervention (T2), and the 3-month follow-up (T3) occasions.

  • Perceived quality of life

    Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 12-week intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test)

Other Outcomes (2)

  • Retention rate

    Data collection will be performed three times at pre-intervention (T1 baseline), after 12-week intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).

  • Session attendance rate

    Session attendance will be recorded during the 12-week intervention

Study Arms (2)

blended Baduanjin and Green Tea consumption program

EXPERIMENTAL

Participants, will receive the 12-week blended Baduanjin (60 mins/session) and Green Tea consumption (2 cups per day for 5 weeks) program

Behavioral: blended Baduanjin and Green Tea consumption program

Non-treatment control

PLACEBO COMPARATOR

Participants will receive biweekly telephone calls within 12 weeks.Each call will last about 5 minutes.

Behavioral: Non-treatment control

Interventions

The participants will be invited to attend both BDJ exercise and GT consumption interventions for 12 weeks. The exercise instructor will provide group teaching with individual instructions on specific movements. Participants will also adopt a dose of 3g tea with 200ml water, 2 cups daily. The tea consumption will last 12 weeks in this project to keep the same intervention duration as BDJ group.

blended Baduanjin and Green Tea consumption program

Participants will receive biweekly telephone calls within 12 weeks.Each call will last about 5 minutes.The participants will be asked several questions about their physical exercise and tea consumption behaviors.

Non-treatment control

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • community-dwelling older adults aged 65 to 84 years, who are youngest-old and middle-old with relatively stable health status compared with oldest-old aged 85 years and above
  • Scoring 5-15 using the Chinese version of Geriatric Depression Scale.
  • Access the smartphone and internet through which the Hospital Authority (HA) HA Go mobile app.
  • Pass the PAR-Q screening and no contraindications for physical exercise.
  • No history of smoking.

You may not qualify if:

  • suffer from cognitive impairment identified by the Chinese version of the Mini-Mental Status Examination (i.e., score \< 24).
  • regularly consume tea or coffee (≥3 times/day, last for ≥6 months) as these habitual behaviors can contaminate the effects of tea consumption intervention per se.
  • Individuals with contraindications for tea consumption, such as insomnia, anemia, neurasthenia, hyperthyroidism, digestive ulcers, etc.
  • The concurrent use of sedative and tranquilizer medications, such as benzodiazepines and barbiturates.
  • take warfarin;
  • Participants are attending other health projects related to physical exercise and diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bliss District Elderly Community Centre

Kwun Tong, Hong Kong

RECRUITING

Related Publications (17)

  • Zhao CN, Tang GY, Cao SY, Xu XY, Gan RY, Liu Q, Mao QQ, Shang A, Li HB. Phenolic Profiles and Antioxidant Activities of 30 Tea Infusions from Green, Black, Oolong, White, Yellow and Dark Teas. Antioxidants (Basel). 2019 Jul 10;8(7):215. doi: 10.3390/antiox8070215.

    PMID: 31295859BACKGROUND
  • Wan Z, Qin X, Tian Y, Ouyang F, Wang G, Wan Q. Long-Term Consumption of Green Tea Can Reduce the Degree of Depression in Postmenopausal Women by Increasing Estradiol. Nutrients. 2023 Oct 25;15(21):4514. doi: 10.3390/nu15214514.

    PMID: 37960167BACKGROUND
  • Souza PB, de Araujo Borba L, Castro de Jesus L, Valverde AP, Gil-Mohapel J, Rodrigues ALS. Major Depressive Disorder and Gut Microbiota: Role of Physical Exercise. Int J Mol Sci. 2023 Nov 28;24(23):16870. doi: 10.3390/ijms242316870.

    PMID: 38069198BACKGROUND
  • Pan CW, Ma Q, Sun HP, Xu Y, Luo N, Wang P. Tea Consumption and Health-Related Quality of Life in Older Adults. J Nutr Health Aging. 2017;21(5):480-486. doi: 10.1007/s12603-016-0784-0.

    PMID: 28448076BACKGROUND
  • Luo X, Zhao M, Zhang Y, Zhang Y. Effects of baduanjin exercise on blood glucose, depression and anxiety among patients with type II diabetes and emotional disorders: A meta-analysis. Complement Ther Clin Pract. 2023 Feb;50:101702. doi: 10.1016/j.ctcp.2022.101702. Epub 2022 Nov 8.

    PMID: 36423358BACKGROUND
  • Leung, K., Tay, M., Cheng, S., & Lin, F. (1997). Hong Kong Chinese version World Health Organization Quality of Life Measure-Abbreviated Version WHOQoL-BREF (HK). Hong Kong: Hong Kong Hospital Authority.

    BACKGROUND
  • Kelly JR, Borre Y, O' Brien C, Patterson E, El Aidy S, Deane J, Kennedy PJ, Beers S, Scott K, Moloney G, Hoban AE, Scott L, Fitzgerald P, Ross P, Stanton C, Clarke G, Cryan JF, Dinan TG. Transferring the blues: Depression-associated gut microbiota induces neurobehavioural changes in the rat. J Psychiatr Res. 2016 Nov;82:109-18. doi: 10.1016/j.jpsychires.2016.07.019. Epub 2016 Jul 25.

    PMID: 27491067BACKGROUND
  • Jin Y, Sun HL, Lam SC, Su Z, Hall BJ, Cheung T, Qin MZ, Ng CH, Xiang YT; International Research Collaboration on COVID-19. Depressive symptoms and gender differences in older adults in Hong Kong during the COVID-19 pandemic: a network analysis approach. Int J Biol Sci. 2022 Jun 6;18(10):3934-3941. doi: 10.7150/ijbs.69460. eCollection 2022.

    PMID: 35844786BACKGROUND
  • Jin X, Yang S, Lu J, Li Y, Zhao Y, Li D, Wang X, Liu L, Wu M. Exploring the therapeutic mechanism of Baduanjin in the treatment of elderly stable angina pectoris based on the gut microbiota-lipid metabolism spectrum: Study protocol for a randomized controlled trial. Front Public Health. 2022 Oct 31;10:1027839. doi: 10.3389/fpubh.2022.1027839. eCollection 2022.

    PMID: 36388277BACKGROUND
  • Jia W, Tang Q, Zou Y, Yang Y, Wu W, Xu W. Investigating the antidepressant effect of Ziyan green tea on chronic unpredictable mild stress mice through fecal metabolomics. Front Microbiol. 2023 Aug 24;14:1256142. doi: 10.3389/fmicb.2023.1256142. eCollection 2023.

    PMID: 37692389BACKGROUND
  • Huang Y, Li L, Gan Y, Wang C, Jiang H, Cao S, Lu Z. Sedentary behaviors and risk of depression: a meta-analysis of prospective studies. Transl Psychiatry. 2020 Jan 22;10(1):26. doi: 10.1038/s41398-020-0715-z.

    PMID: 32066686BACKGROUND
  • Hu L, Ni Z, Zhao K, Li X, Gao X, Kang Y, Yu Z, Qin Y, Zhao J, Peng W, Lu L, Sun H. The association between oral and gut microbiota in male patients with alcohol dependence. Front Microbiol. 2023 Jul 28;14:1203678. doi: 10.3389/fmicb.2023.1203678. eCollection 2023.

    PMID: 37577447BACKGROUND
  • Lopez-Torres Hidalgo J; DEP-EXERCISE Group. Effectiveness of physical exercise in the treatment of depression in older adults as an alternative to antidepressant drugs in primary care. BMC Psychiatry. 2019 Jan 14;19(1):21. doi: 10.1186/s12888-018-1982-6.

    PMID: 30642326BACKGROUND
  • Dou, W., Su, S., Zhao, Y., Guo, X., Zhang, Z., Yao, J., & Wang, S. (2020). Effect of Baduanjin on the balancing ability and intestinal flora for older adults. China Preventive Medicine Journal, 32(4), 425-428.

    BACKGROUND
  • Cheung DST, Chau PH, Lam TC, Ng AYM, Kwok TWH, Takemura N, Woo J, Yu DS, Lin CC. A pilot randomized controlled trial using Baduanjin qigong to reverse frailty status among post-treatment older cancer survivors. J Geriatr Oncol. 2022 Jun;13(5):682-690. doi: 10.1016/j.jgo.2022.02.014. Epub 2022 Mar 7.

    PMID: 35272982BACKGROUND
  • Bigarella LG, Ballotin VR, Mazurkiewicz LF, Ballardin AC, Rech DL, Bigarella RL, Selistre LDS. Exercise for depression and depressive symptoms in older adults: an umbrella review of systematic reviews and Meta-analyses. Aging Ment Health. 2022 Aug;26(8):1503-1513. doi: 10.1080/13607863.2021.1951660. Epub 2021 Jul 30.

    PMID: 34328049BACKGROUND
  • Manshadi Seyed Ali D, Seyed Alireza M, Mohammad Reza S, Jayran Z, SeyedAhmad S, Shams Ali R, Seyed Saeid M, Ali AA. Effect of green tea consumption in treatment of mild to moderate depression in Iranian patients living with HIV: A double-blind randomized clinical trial. Chin Herb Med. 2020 Nov 26;13(1):136-141. doi: 10.1016/j.chmed.2020.08.002. eCollection 2021 Jan.

    PMID: 36117757BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yanping Duan

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Duan

CONTACT

Yanping Duan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It's a single-blinded randomized controlled trial study. A total of 48 community-dwelling older adults (aged 65-84 years) with depressive symptoms will be randomly assigned to a blended intervention group or an active control group. The blended intervention group will receive a 12-week program, including Baduanjin exercise (2 sessions/week, 60 min/session) and green tea consumption (3g tea bag with 2cups daily). The active control group will receive biweekly telephone calls in 12 weeks to answer questions about their physical exercise and tea consumption behaviors.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations