Gut microbiome and blood markers after habitual herbal tea consumption (SRTT)
| ISRCTN | ISRCTN32761538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32761538 |
| Secondary identifying numbers | 23306 |
- Submission date
- 27/04/2023
- Registration date
- 02/05/2023
- Last edited
- 26/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This is a dual centre research study being conducted by the Future Foods/SMART recovery Team in the Well-being and Health Assessment Research Unit (WARU) at Aberystwyth University and Trimsaran Community Health Centre. This project has been funded by the Welsh Government under a Covid Challenge Recovery fund led by Aberystwyth University.
TeTrimTeas intends is to establish a long-term cooperative with local growers and producers who will become partners in the business, with profit share to local growers and producers. The overall aim of the company is to produce quality, science-based botanical/herbal teas to improve health and wellbeing, growing as many of the ingredients locally and organically, to reduce food-to-fork miles within the decarbonisation and sustainability agendas in Wales.
TeTrimTeas have created herbal green tea blends with honey, improving on existing Chinese formulation, and would like to test it as ‘health tea’. The recruited cohort will be randomised into one of three intervention teas. They would like to explore if consumption of the teas for 21 days has an impact on digestion and potentially help control weight gain. We will use high resolution metabolomics to investigate the chemical composition of capillary blood samples. We will also assess lipid composition in capillary bloods and the microbiome of stools. Results would advance product development and data would be used in grant applications into the health benefits of the herbal teas.
Who can participate?
Healthy adult participants (>18 years)
What does the study involve?
The recruited cohort will be randomised into one of three intervention teas (green tea control, senna herbal mix and rhubarb root herbal mix). This will be double blinded so neither the participant nor the researcher will know what group they have been allocated into. Information can be disclosed at the end of the study. Participants will come to WARU or Trimsaran Community Health Centre for induction and study visits.
'Diet-monitoring' period (two days before the study)
Prior to the experimental session it is important that all participants undergo a period where foods are recorded. This will help the researchers interpret any results after consumption of the test/control food. We would ask them to refrain from taking any over-the-counter medication (such as ibuprofen, paracetamol, aspirin, cough/ cold remedies) or herbal supplements, and to let us know if they find that it is necessary to take any such medication during the trial.
Experimental session- 21 days
Morning: Participants will come to WARU or Trimsaran Community Health Centre for their pre-organised timeslot to allow researchers to collect a fasted capillary (fingerpick) blood samples and stool sample. They may consume their breakfast after their visit. They will also collect their tea bags. Researchers will also take participants weight and height andcollect diet data (PDQS) and stool scores (Bristol Stool scale).
Over 21 days: we would ask the participants to consume a cup of tea after their last meal/snack of the day (post 6pm) daily, for 21 days. We would ask them not to consume anything after the tea. In a cup/mug we would ask them to place a 2.5-g tea bag and add 190 ml of hot water (80-100°C) and stir clockwise 10 consecutive times to allow for optimal infusion and then allow to brew for 5 minutes, before removal.
After the experimental period:
Before their final visit (or at their final visit): we would like you to fill in another food questionnaire and a stool scale.
Morning of their final visit. We would ask the participant to come to WARU or Trimsaran Community Health Centre for their pre-organised timeslot to allow us to collect a fasted capillary (fingerpick) blood samples and stool sample. We will also take their weight and height. They may consume their breakfast after their visit. Afterwards, they can go back to their 'normal' eating pattern.
What are the benefits and risks of participating?
There is no financial gain for you if you decide to join this study. You will allow us to gain important insight into the action of a health tea using a combination of techniques including metabolomics, gut microbiome analysis and lipid analysis. This will be the first time this type of research will have been conducted and will be a valuable pilot study before we can investigate any human health benefits in the future. We will provide you with tea for the experimental days.
For the capillary blood samples, some people may feel nervous and on rare occasions dizziness may occur. Alongside green tea and honey, the intervention teas may contain honeysuckle flower, Cassia seed, lotus leaf, five-leaf ginseng, hawthorn fruit, senna leaf and rhubarb root. The herbal teas contain low amount of caffeine and, if large quantities of the herbal teas are consumed in one go, a laxative effect may occur.
Where is the study run from?
Well-being and Health Assessment Research Unit (WARU) at Aberystwyth University and Trimsaran Community Health Centre (UK)
When is the study starting and how long is it expected to run for?
October 2022 to December 2023
Who is funding the study?
This project has been funded by the Welsh Government under a Covid Challenge Recovery fund led by Aberystwyth University (UK)
Who is the main contact?
Amanda J Lloyd, abl@aber.ac.uk
Contact information
Principal Investigator
Department of Life Sciences
Aberystwyth
SY23 1RD
United Kingdom
 ORCID ID |
0000-0002-0775-3537 |
|---|---|
| Phone | +44 7811618109 |
| abl@aber.ac.uk |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, University/medical school/dental school |
| Study type | Quality of life |
| Participant information sheet | 43564 PIS 27Apr2023.pdf |
| Scientific title | Gut microbiome, and plasma lipids after habitual herbal tea consumption in a healthy human cohort |
| Study acronym | SRTT |
| Study objectives | Rhubarb root tea is better than green and senna tea in the impact on gut microbiome and plasma lipids |
| Ethics approval(s) | Approved 11/10/2022, Research Ethics Panel, Aberystwyth University (Aberystwyth University, Reception, Penglais, Aberystwyth, Ceredigion, SY23 3FL, UK; +44 (0) 1970 621694; lif1@aber.ac.uk), ref: 23767 |
| Health condition(s) or problem(s) studied | Overweight individuals, high BMI |
| Intervention | The recruited cohort will be randomised into one of three intervention teas (green tea control, senna herbal mix and rhubarb root herbal mix) using an online tool and matched for gender, age and location (site). We will explore if consumption of the teas for 21 days has an impact on digestion and potentially help control weight gain. We will use high resolution metabolomics to investigate the chemical composition of capillary blood samples, in particular the short chain fatty acids. They will also assess lipid composition in capillary bloods and the microbiome of stools. Diet data, stool consistency and anthropometric measurements will be collected pre and post intervention. Detailed Description: TeTrimTeas has created herbal green tea blends, improving on existing Chinese formulation, and would like to test it as 'health tea'. The recruited cohort will be randomised into one of three intervention teas (green tea control, senna herbal mix and rhubarb root herbal mix). This will be double blinded so neither the participant nor the researcher will know what group they have been allocated into. Information can be disclosed at the end of the study. Participants will come to WARU or Trimsaran Community Health Centre for induction and study visits. The experimental sequence 'Diet-monitoring' period (two days before the study) Prior to the experimental session it is important that all participants undergo a period where foods are recorded. This will help the researchers interpret any results after consumption of the test/control food. We would ask them to refrain from taking any over-the-counter medication (such as ibuprofen, paracetamol, aspirin, cough/ cold remedies) or herbal supplements, and to let us know if they find that it is necessary to take any such medication during the trial. Experimental session- 21 days Morning: Participants will come to WARU or Trimsaran Community Health Centre for their pre-organised timeslot to allow researchers to collect a fasted capillary (fingerpick) blood samples and stool sample. They may consume their breakfast after their visit. They will also collect their tea bags. Researchers will also take participants weight and height andcollect diet data (PDQS) and stool scores (Bristol Stool scale). Over 21 days: we would ask the participants to consume a cup of tea after their last meal/snack of the day (post 6pm) daily, for 21 days. We would ask them not to consume anything after the tea. In a cup/mug we would ask them to place a 2.5g tea bag and add190ml of hot water (80-100◦C) and stir clockwise 10 consecutive times to allow for optimal infusion and then allow to brew for 5 minutes, before removal. After the experimental period: Before their final visit (or at their final visit): we would like you to fill in another food questionnaire and a stool scale. Morning of their final visit. We would ask the participant to come to WARU or Trimsaran Community Health Centre for their pre-organised timeslot to allow us to collect a fasted capillary (fingerpick) blood samples and stool sample. We will also take their weight and height. They may consume their breakfast after their visit. Afterwards, they can go back to their 'normal' eating pattern. |
| Intervention type | Supplement |
| Primary outcome measure | Change in total cholesterol, HDL, LDL, triglycerides, non-HDL, cholesterol/HDL ratio after the intervention teas (between teas and between pre/post) measured in capillary bloods |
| Secondary outcome measures | 1. Change in gut microbiome between arms and between pre and post intervention measured using 16S rRNA Amplicon Sequencing in stools 2. Change in diet score between arms and between pre and post intervention measured using the Prime Diet Quality Score (PDQS) questionnaire 3. Change in stool score (using the Bristol stool score) between arms and between pre and post intervention 4. Change in weight/BMI/waist: hip between arms and between pre and post intervention 5. Change in concentration of short chain fatty acids between arms and between pre and post intervention measured using GC-FID |
| Overall study start date | 11/10/2022 |
| Completion date | 10/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 53 |
| Key inclusion criteria | 1. Consenting adults >18 years 2. Commit to fasting capillary blood collection 3. Commit to stool sampling collection 4. Able to refrain from taking any over-the-counter medication or herbal supplements during the diet monitoring and experimental periods. 5. Able to prepare and consume the tea during the experimental days, after the last meal/snack of the day and not to consume anything afterwards 6. Fill in diet diaries, FFQ and stool ranking 7. Able to inform the researcher if any antibiotics or heavy alcohol is consumed over the intervention period |
| Key exclusion criteria | 1. Showing (or anyone within the household) any COVID-19 symptoms (see COVID-19 basic health screen)* 2. Higher risk or vulnerable from coronavirus or live with someone at a higher risk of a severe illness from COVID-19 (over 70, undergoing cancer treatment, high risk of getting infections). 3. Had a letter from the NHS advising you to shield (isolate) 4. Had been at risk of exposure to COVID-19 such as travel, contact with someone with COVID-19, been exposed to the virus, or has been asked to self-isolate by the track and trace system. 5. Serious health conditions that require daily long-term medications (including immunosuppressants) 6. A history or current diabetes, lung issues, gut inflammation (Crohns, IBD), digestive disorders 7. Diagnosed with a serious health condition within the last 12 months 8. Pregnant 9. Play sports at a high level (more than 7h/week or 1h/day) 10. Smoking 11. consume high dose of alcohol > 21 unit per week for men and > 14 units per week for women 12. Food allergy /food intolerance/ eating disorder or are on a specially prescribed diet *If the potential participant has had COVID-19 previously (and are fully recovered and not within isolation) then they are eligible to join the study |
| Date of first enrolment | 11/06/2023 |
| Date of final enrolment | 11/07/2023 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Penglais Campus
Aberystwyth
SY23 3FD
United Kingdom
Trimsaran
SA17 4AA
United Kingdom
Sponsor information
Government
Food Business Manager
Food Division
Llandudno Junction
LL31 9RZ
Wales
United Kingdom
| Phone | +44 300 062 5139 |
|---|---|
| wendy.jones@gov.wales | |
| Website | http://gov.wales/?skip=1&lang=en |
"ROR" |
https://ror.org/000wh6t45 |
Industry
Y Pelican 45 Heol Waunyclun
Trimsaran
SA17 4BL
Wales
United Kingdom
| Phone | +44 7799431060 |
|---|---|
| mari@tetrimteas.cymru |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Welsh Government, The Welsh Government
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal . We plan to disseminate in July 2023 and publish September 2023 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request (Amanda Lloyd, abl@aber.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/04/2023 | 28/04/2023 | No | Yes |
Additional files
Editorial Notes
26/11/2024: The following changes were made to the trial record:
1. The overall start date was changed from 16/05/2022 to 11/10/2022.
2. The overall end date was changed from 10/12/2022 to 10/12/2023.
3. The recruitment start date was changed from 11/10/2022 to 11/06/2023.
4. The recruitment end date was changed from 17/11/2022 to 11/07/2023.
5. The plain English summary was updated to reflect these changes.
28/04/2023: Trial's existence confirmed by Research Ethics Panel, Aberystwyth University.
