Effects of different coffee recipes on mental health performance in community adults
| ISRCTN | ISRCTN93571556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93571556 |
- Submission date
- 14/10/2022
- Registration date
- 11/11/2022
- Last edited
- 07/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Coffee is good for health as known worldwide, and the smell of coffee aroma and the mixture of a number of bio-natural compounds such as antioxidant polyphenols can alleviate participants’ depression symptoms in some studies. Darker roasted coffee beans have a stronger coffee aroma and fewer polyphenols. The aim of this study is to determine the effects of different coffee recipes on mental health performance in adults.
Who can participate?
Healthy working adults aged over 22 years
What does the study involve?
Participants are randomly allocated into two equal groups. Group A drinks Recipe A coffee and Group B drinks Recipe B coffee (200 ml before noon three times a week for 12 weeks).
What are the possible benefits and risks of participating?
By participating in this study, participants get free three drip coffee bags a week for 3 months. Completing an online survey related to mental health may be distressing. Participants can pause to drink the coffee beverages during the study or withdraw entirely if they wish.
Where is the study run from?
1. National Association of Small & Medium Enterprise, R. O. C. (Taiwan)
2. Chiayi Campus of Chang Gung University of Science and Technology (Taiwan)
3. Chi Mei Medical Center (Taiwan)
When is the study starting and how long is it expected to run for?
April 2020 to March 2021
Who is funding the study?
This study/project is funded by the Chronic Diseases and Health Promotion Research Center, Chang Gung University of Science, Chiayi Campus of Chang Gung University of Science and Technology (CGUST) (Taiwan)
Who is the main contact?
Dr Chia-Hsiu Chang
chchang01@mail.cgust.edu.tw
Contact information
Principal Investigator
14F-1, No.465, LanJing St.
Chiayi City
60047
Taiwan
 ORCID ID |
0000-0002-1381-8077 |
|---|---|
| Phone | +886 (0)5 3628800 |
| chchang01@mail.cgust.edu.tw |
Study information
| Study design | Multicenter interventional double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please contact the investigator, Chia- Hsiu, Chang, email address: chchang01@mail.cgust.edu.tw. |
| Scientific title | Effects of different coffee recipes on mental health performance in community adults |
| Study acronym | CGA |
| Study objectives | 1. Caffeine and chlorogenic acid levels are an effective energy booster that can improve mental health performance in adults 2. Trigonelline can also improve the mental health performance of adults |
| Ethics approval(s) | Approved 10/07/2020, Chang Gung Medical Foundation Institutional Review Board (No. 199, Dunhua N. Rd., Songshan Dist., 105 Taipei City, Taiwan (R.O.C.); +886-33196200#3716; yijiun@cgmh.org.tw), ref: 202000636A3D001 |
| Health condition(s) or problem(s) studied | Mental health |
| Intervention | Participants were randomly allocated into two equal groups through a random lottery by researchers. Group A ingested Recipe A 200 ml coffee drink with 5 g dark roasted Ethiopian coffee beans (Arabica Variety: Original) mixed with 5 g light roasted Colombian Arabica coffee beans (Arabica Variety: Bourbon and Typica). Group B ingested Recipe B 200ml coffee drink with 4 g dark roasted Ethiopian coffee beans mixed with 6 g light roasted Colombian coffee beans. The Short Portable Mental Status Questionnaire (SPMSQ) was used to measure cognitive status for all participants, and the 5-item Brief Symptom Rating Scale (5-BSRS) was used to evaluate the difference between baseline and post-test for mental health performance in 58 adults. The coffee beans in the study were roasted by a roaster who was certificated by the Specialty Coffee Association of America. After grinding, two recipes of coffee beans were packaged in drip bags. All the participants were required to obey the process as follows: pouring 200 ml 97°C hot water into the coffee drip bags with a cup and having coffee beverages three times a week before 12:00 at noon for 12 weeks. |
| Intervention type | Other |
| Primary outcome measure | 1. Cognitive status measured using SPMSQ at pretest (baseline) and posttest (12 weeks later) 2. Mental health assessed using 5-BSRS at pretest (baseline) and posttest (12 weeks later) |
| Secondary outcome measures | 1. Coffee content of caffeine, 4-O-caffeoylquinin acid, chlorogenic acid (CGA), 5-O-caffeoylquinic acid, and trigonelline measured using high-performance liquid chromatography (HPLC) at posttest (12 weeks later) 2. Coffee content of 1-methy-2-pyrrolidone, CNMP, 2,5–dimethylpyrazine measured using gas chromatography at posttest (12 weeks later) |
| Overall study start date | 22/04/2020 |
| Completion date | 01/03/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 58 |
| Key inclusion criteria | 1. Willing to sign a written participant consent form 2. Male and female subjects currently working 3. Normal SPMSQ test 4. Men and women over the age of 22 years |
| Key exclusion criteria | 1. Pregnant women or patients with osteoporosis 2. Major surgery within 14 days 3. Currently suffering from disease and in the acute phase |
| Date of first enrolment | 20/08/2020 |
| Date of final enrolment | 21/08/2020 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Jiapu Rd
Puzi City
61363
Taiwan
Roosevelt Rd
Da’an Dist
Taipei City
10646
Taiwan
Yongkang Dist
Tainan City
71004
Taiwan
Sponsor information
University/education
No.2, ChiaPu Rd
Puzi City
61362
Taiwan
| Phone | +886 (0)5 3628800 ext 2607 |
|---|---|
| mcchi@mail.cgust.edu.tw | |
| Website | https://cdhprc.cgust.edu.tw/ |
"ROR" |
https://ror.org/009knm296 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed journal 2. Study protocol and statistical analysis plan will be available when they are completed |
| IPD sharing plan | After the primary results have been published, the individual participant data (IPD) and associated documentation, including the protocol and statistical analysis data, will be prepared to be shared with other researchers. The people who request access to the IPD will be reviewed by all researchers following the CGUST policy on data sharing. Please contact Dr Chia-Hsiu Chang (chchang01@mail.cgust.edu.tw) for general project enquiries and participant-level data. We can offer the data approved by the participants and delinked personal data after the article has been published for 3 years. |
Editorial Notes
01/11/2022: Trial's existence confirmed by the Chang Gung Medical Foundation Institutional Review Board.
