ObesityEarly Phase 1SRTTNCT05862532
Gut Microbiome and Blood Markers After Habitual Herbal Tea Consumption
A Early Phase 1 study testing TeTrimTeas welsh Herbal tea with rhubarb root, TeTrimTeas welsh Herbal tea with senna and TeTrimTeas welsh Herbal tea with green tea in people with Obesity and Well-being, run by Aberystwyth University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Well-being
- What is being tested?
- TeTrimTeas welsh Herbal tea with rhubarb root, TeTrimTeas welsh Herbal tea with senna and TeTrimTeas welsh Herbal tea with green tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2022to 31 May 2023
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting adults >18 y Age
- Commit to fasting capillary blood collection
- Commit to stool sampling collection
- Able to refrain from taking any over-the-counter medication or herbal supplements during the diet monitoring and experimental periods.
- 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
- Fill in diet diaries, FFQ and stool ranking
- Able to inform the researcher if any antibiotics or heavy alcohol is consumed over the intervention period
Who cannot join
- Showing (or anyone within the household) any COVID-19 symptoms (see COVID-19 basic health screen)*
- 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).
- Had a letter from the NHS advising you to shield (isolate)
- 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.
- Serious health conditions that require daily long-term medications (including immunosuppressants)
- A history or current diabetes, lung issues, gut inflammation (Crohns, IBD), digestive disorders
Show all 13Show fewer
- Diagnosed with a serious health condition within the last 12 months
- Pregnant
- Play sports at a high level (more than 7h/week or 1h/day)
- Smoking
- consume high dose of alcohol > 21 unit per week for men and > 14 units per week for women
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Well-being and Health Assessment Research Unit (WARU)
Aberystwyth, Ceredigion, SY23 3FD
About this study
Official title: TeTrimTeas: Gut Microbiome and Blood Lipid Markers After Habitual Herbal Tea Consumption
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, 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). They would like to explore if consumption of the teas for 21 days has an impact on digestion and potentially help control weight gain.
Aberystwyth University 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. Results will advance product development and data would be used in grant applications into the health benefits of the herbal teas.
Read the 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. The researchers 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 and collect diet data (PDQS) and stool scores (Bristol Stool scale).
Over 21 days: the researchers would ask the participants to consume a cup of tea after their last meal/snack of the day (post 6pm) daily, for 21 days. The researchers would ask them not to consume anything after the tea. In a cup/mug the researchers would ask them to place a 2.5g tea bag and add 190ml 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): the researchers would like participants to fill in another food questionnaire and a stool scale.
Morning of their final visit. The researchers 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. The researchers 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.
- Conditions
- Obesity, Well-being
- Being tested
- TeTrimTeas welsh Herbal tea with rhubarb root, TeTrimTeas welsh Herbal tea with senna, TeTrimTeas welsh Herbal tea with green tea
- Keywords
- Herbal tea infusions, Lipid composition, Gut microbiome, Short Chain fatty acids, Well-being
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeTrimTeas welsh Herbal tea with rhubarb rootDietary supplement
TeTrimTeas welsh Herbal tea with green tea and rhubarb root
TeTrimTeas welsh Herbal tea with sennaDietary supplement
TeTrimTeas welsh Herbal tea with green tea and senna
TeTrimTeas welsh Herbal tea with green teaDietary supplement
TeTrimTeas welsh Herbal tea with green tea
| Study group | Role | What they receive |
|---|---|---|
| Welsh Herbal tea with Senna | Experimental | Welsh Herbal tea with green tea and Senna Receives: Dietary Supplement: TeTrimTeas welsh Herbal tea with senna |
| Welsh Herbal tea with rhubarb root | Experimental | Welsh Herbal tea with green tea and rhubarb root Receives: Dietary Supplement: TeTrimTeas welsh Herbal tea with rhubarb root |
| Green tea | Active comparator | Dartmoor green tea Receives: Dietary Supplement: TeTrimTeas welsh Herbal tea with green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total plasma Cholesterol after the rhubarb root tea
Change in total Cholesterol (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Cholesterol after 21 days
Change in total plasma Cholesterol after the rhubarb root tea
Change in total Cholesterol (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from total Cholesterol plasma after the rhubarb root tea when compared with senna tea plasma Cholesterol after 21 days
Change in total plasma Cholesterol after the rhubarb root tea
Change in total Cholesterol (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from total Cholesterol plasma after the rhubarb root tea when compared with green tea plasma Cholesterol after 21 days
Change in total plasma Cholesterol after the senna tea
Change in total Cholesterol (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Cholesterol after 21 days
Change in total plasma Cholesterol after the green tea
Change in total Cholesterol (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Cholesterol after 21 days
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea when compared with senna tea plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea when compared with green tea plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the senna tea
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the green tea
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Secondary outcomes (30)
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the rhubarb root tea
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the rhubarb root tea
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Increase of plasma High-Density Lipoprotein cholesterol (HDL-C) after Rhubarb root tea when compared with senna tea plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the rhubarb root tea
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Increase of plasma High-Density Lipoprotein cholesterol (HDL-C) after Rhubarb root tea when compared with green tea plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the senna tea
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Measured: Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the green tea
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Measured: Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma Triglycerides after the rhubarb root tea
Change in Triglycerides (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma Triglycerides after 21 days
Change in plasma Triglycerides after the senna tea
Change in Triglycerides (mmol/L) after the senna measured in capillary bloods using AFINION S100
Measured: Decrease from senna tea plasma Triglycerides after 21 days
Change in plasma Triglycerides after the green tea
Change in Triglycerides (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Measured: Decrease from green tea plasma Triglycerides after 21 days
Change in plasma Triglycerides after the rhubarb root tea
Change in Triglycerides (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from rhubarb root plasma Triglycerides after 21 days when compared with senna tea plasma Triglycerides after 21 days
Change in plasma Triglycerides after the rhubarb root tea
Change in Triglycerides (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from rhubarb root plasma Triglycerides after 21 days when compared with green tea plasma Triglycerides after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the rhubarb root tea
Change in non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease from Baseline plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the senna tea
Change in non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Measured: Decrease from senna tea plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the green tea
Change in non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Measured: Decrease from green tea plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the rhubarb root tea
Change in non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) (mmol/L) after the after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease of plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days of the rhubarb root tea when compared with 21 days of the senna tea
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the rhubarb root tea
Change in non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Measured: Decrease of plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days of the rhubarb root tea when compared with 21 days of the green tea
Diet choices change measured using the Prime Diet Quality Score
Measured using the Prime Diet Quality Score. The Prime Diet Quality Score (PDQS) measures intake of the 22 component foods/food groups over the last 30 days with seven possible responses for each component ranging from "once a month or less" to "≥ 2 times/day." Scores are then summed to create a PDQS total diet quality score with a possible score from 0 to 126 with higher scores indicating a healthier diet.
Measured: Increased score from baseline Prime Diet Quality Score at 21 days after the Rhubarb root tea
Diet choices change measured using the Prime Diet Quality Score
Measured using the Prime Diet Quality Score. The Prime Diet Quality Score (PDQS) measures intake of the 22 component foods/food groups over the last 30 days with seven possible responses for each component ranging from "once a month or less" to "≥ 2 times/day." Scores are then summed to create a PDQS total diet quality score with a possible score from 0 to 126 with higher scores indicating a healthier diet.
Measured: Increased score from baseline Prime Diet Quality Score at 21 days after the senna tea
Diet choices change measured using the Prime Diet Quality Score
Measured using the Prime Diet Quality Score. The Prime Diet Quality Score (PDQS) measures intake of the 22 component foods/food groups over the last 30 days with seven possible responses for each component ranging from "once a month or less" to "≥ 2 times/day." Scores are then summed to create a PDQS total diet quality score with a possible score from 0 to 126 with higher scores indicating a healthier diet.
Measured: Increased score from baseline Prime Diet Quality Score at 21 days after the green tea
Diet choices change measured using the Prime Diet Quality Score
Measured using the Prime Diet Quality Score. The Prime Diet Quality Score (PDQS) measures intake of the 22 component foods/food groups over the last 30 days with seven possible responses for each component ranging from "once a month or less" to "≥ 2 times/day." Scores are then summed to create a PDQS total diet quality score with a possible score from 0 to 126 with higher scores indicating a healthier diet.
Measured: Increased score from the Rhubarb root tea Prime Diet Quality Score at 21 days compared with the senna tea at 21 days
Diet choices change measured using the Prime Diet Quality Score
Measured using the Prime Diet Quality Score. The Prime Diet Quality Score (PDQS) measures intake of the 22 component foods/food groups over the last 30 days with seven possible responses for each component ranging from "once a month or less" to "≥ 2 times/day." Scores are then summed to create a PDQS total diet quality score with a possible score from 0 to 126 with higher scores indicating a healthier diet.
Measured: Increased score from the Rhubarb root tea Prime Diet Quality Score at 21 days compared with the green tea at 21 days
BMI change measured by weight and height
BMI change measured by weight and height will be combined to report BMI in kg/m^2
Measured: Decrease score from baseline BMI Score at 21 days after the Rhubarb root tea
BMI change measured by weight and height
BMI change measured by weight and height will be combined to report BMI in kg/m^2
Measured: Decrease score from baseline BMI Score at 21 days after the senna tea
BMI change measured by weight and height
BMI change measured by weight and height will be combined to report BMI in kg/m^2
Measured: Decrease score from baseline BMI Score at 21 days after the green tea
BMI change measured by weight and height
BMI change measured by weight and height will be combined to report BMI in kg/m^2
Measured: Decreased score from the Rhubarb root tea BMI at 21 days compared with the senna tea at 21 days
BMI change measured by weight and height
BMI change measured by weight and height will be combined to report BMI in kg/m^2
Measured: Decreased score from the Rhubarb root tea BMI at 21 days compared with the green tea at 21 days
Changes in short chain fatty acids concentrations in plasma
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
Measured: Increased concentration of total short chain fatty acids from baseline concentration at 21 days after the Rhubarb root tea
Changes in short chain fatty acids concentrations in plasma
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
Measured: Increased concentration of total short chain fatty acids from baseline concentration at 21 days after the senna tea
Changes in short chain fatty acids concentrations in plasma
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
Measured: Increased concentration of total short chain fatty acids from baseline concentration at 21 days after the green tea
Changes in short chain fatty acids concentrations in plasma
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
Measured: Increased concentration of total short chain fatty acids after the rhubarb root tea at 21 days compared with the senna tea after 21 days
Changes in short chain fatty acids concentrations in plasma
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
Measured: Increased concentration of total short chain fatty acids after the rhubarb root tea at 21 days compared with the green tea after 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start17 Nov 2022
- Primary completion10 Dec 2022
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two intervention arms and one placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aberystwyth University
- Sponsor type
- University, hospital or other
- Collaborators
- TeTrimTeas Cyf
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862532
- Sponsor's protocol ID
- 23306
- Acronym
- SRTT
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeTrimTeas: Gut Microbiome and Blood Lipid Markers After Habitual Herbal Tea Consumption
- ClinicalTrials.gov ID
- NCT05862532
- Acronym / sponsor ID
- SRTT / 23306
- Conditions
- Obesity, Well-being
- Keywords
- Herbal tea infusions, Lipid composition, Gut microbiome, Short Chain fatty acids, Well-being
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Aberystwyth UniversityUniversity, hospital or other
- Collaborators
- TeTrimTeas Cyf
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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). They would like to explore if consumption of the teas for 21 days has an impact on digestion and potentially help control weight gain.
Aberystwyth University 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. Results will advance product development and data would be used in grant applications into the health benefits of the herbal teas.
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. The researchers 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 and collect diet data (PDQS) and stool scores (Bristol Stool scale).
Over 21 days: the researchers would ask the participants to consume a cup of tea after their last meal/snack of the day (post 6pm) daily, for 21 days. The researchers would ask them not to consume anything after the tea. In a cup/mug the researchers would ask them to place a 2.5g tea bag and add 190ml 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): the researchers would like participants to fill in another food questionnaire and a stool scale.
Morning of their final visit. The researchers 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. The researchers 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Two intervention arms and one placebo
| Arm | Type | Receives |
|---|---|---|
| Welsh Herbal tea with Senna | Experimental | Dietary Supplement: TeTrimTeas welsh Herbal tea with sennaWelsh Herbal tea with green tea and Senna |
| Welsh Herbal tea with rhubarb root | Experimental | Dietary Supplement: TeTrimTeas welsh Herbal tea with rhubarb rootWelsh Herbal tea with green tea and rhubarb root |
| Green tea | Active comparator | Dietary Supplement: TeTrimTeas welsh Herbal tea with green teaDartmoor green tea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consenting adults >18 y Age
- Commit to fasting capillary blood collection
- Commit to stool sampling collection
- Able to refrain from taking any over-the-counter medication or herbal supplements during the diet monitoring and experimental periods.
- 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
Key exclusion criteria (13 listed)
- Showing (or anyone within the household) any COVID-19 symptoms (see COVID-19 basic health screen)*
- 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).
- Had a letter from the NHS advising you to shield (isolate)
- 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.
- Serious health conditions that require daily long-term medications (including immunosuppressants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeTrimTeas welsh Herbal tea with rhubarb rootTeTrimTeas welsh Herbal tea with green tea and rhubarb root | Dietary supplement | Welsh Herbal tea with rhubarb root |
| TeTrimTeas welsh Herbal tea with sennaTeTrimTeas welsh Herbal tea with green tea and senna | Dietary supplement | Welsh Herbal tea with Senna |
| TeTrimTeas welsh Herbal tea with green teaTeTrimTeas welsh Herbal tea with green tea | Dietary supplement | Green tea |
Primary outcome
Change in total plasma Cholesterol after the rhubarb root tea
Time frame: Decrease from Baseline plasma Cholesterol after 21 days
Change in total Cholesterol (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Change in total plasma Cholesterol after the rhubarb root tea
Time frame: Decrease from total Cholesterol plasma after the rhubarb root tea when compared with senna tea plasma Cholesterol after 21 days
Change in total Cholesterol (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Change in total plasma Cholesterol after the rhubarb root tea
Time frame: Decrease from total Cholesterol plasma after the rhubarb root tea when compared with green tea plasma Cholesterol after 21 days
Change in total Cholesterol (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Change in total plasma Cholesterol after the senna tea
Time frame: Decrease from Baseline plasma Cholesterol after 21 days
Change in total Cholesterol (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Change in total plasma Cholesterol after the green tea
Time frame: Decrease from Baseline plasma Cholesterol after 21 days
Change in total Cholesterol (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea
Time frame: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea
Time frame: Decrease from plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea when compared with senna tea plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea
Time frame: Decrease from plasma Low density lipoprotein cholesterol (LDL-C) after the rhubarb root tea when compared with green tea plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the senna tea
Time frame: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Change in plasma Low density lipoprotein cholesterol (LDL-C) after the green tea
Time frame: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-C) after 21 days
Change in Low density lipoprotein cholesterol (LDL-C) (mmol/L) after the green tea measured in capillary bloods using AFINION S100
30 secondary outcomes
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the rhubarb root tea
Time frame: Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the rhubarb root tea
Time frame: Increase of plasma High-Density Lipoprotein cholesterol (HDL-C) after Rhubarb root tea when compared with senna tea plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the rhubarb root tea
Time frame: Increase of plasma High-Density Lipoprotein cholesterol (HDL-C) after Rhubarb root tea when compared with green tea plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the senna tea
Time frame: Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma High-Density Lipoprotein cholesterol (HDL-C) after the green tea
Time frame: Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days
Change in plasma Triglycerides after the rhubarb root tea
Time frame: Decrease from Baseline plasma Triglycerides after 21 days
Change in plasma Triglycerides after the senna tea
Time frame: Decrease from senna tea plasma Triglycerides after 21 days
Change in plasma Triglycerides after the green tea
Time frame: Decrease from green tea plasma Triglycerides after 21 days
Change in plasma Triglycerides after the rhubarb root tea
Time frame: Decrease from rhubarb root plasma Triglycerides after 21 days when compared with senna tea plasma Triglycerides after 21 days
Change in plasma Triglycerides after the rhubarb root tea
Time frame: Decrease from rhubarb root plasma Triglycerides after 21 days when compared with green tea plasma Triglycerides after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the rhubarb root tea
Time frame: Decrease from Baseline plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the senna tea
Time frame: Decrease from senna tea plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the green tea
Time frame: Decrease from green tea plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the rhubarb root tea
Time frame: Decrease of plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days of the rhubarb root tea when compared with 21 days of the senna tea
Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the rhubarb root tea
Time frame: Decrease of plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days of the rhubarb root tea when compared with 21 days of the green tea
Diet choices change measured using the Prime Diet Quality Score
Time frame: Increased score from baseline Prime Diet Quality Score at 21 days after the Rhubarb root tea
Diet choices change measured using the Prime Diet Quality Score
Time frame: Increased score from baseline Prime Diet Quality Score at 21 days after the senna tea
Diet choices change measured using the Prime Diet Quality Score
Time frame: Increased score from baseline Prime Diet Quality Score at 21 days after the green tea
Diet choices change measured using the Prime Diet Quality Score
Time frame: Increased score from the Rhubarb root tea Prime Diet Quality Score at 21 days compared with the senna tea at 21 days
Diet choices change measured using the Prime Diet Quality Score
Time frame: Increased score from the Rhubarb root tea Prime Diet Quality Score at 21 days compared with the green tea at 21 days
BMI change measured by weight and height
Time frame: Decrease score from baseline BMI Score at 21 days after the Rhubarb root tea
BMI change measured by weight and height
Time frame: Decrease score from baseline BMI Score at 21 days after the senna tea
BMI change measured by weight and height
Time frame: Decrease score from baseline BMI Score at 21 days after the green tea
BMI change measured by weight and height
Time frame: Decreased score from the Rhubarb root tea BMI at 21 days compared with the senna tea at 21 days
BMI change measured by weight and height
Time frame: Decreased score from the Rhubarb root tea BMI at 21 days compared with the green tea at 21 days
Changes in short chain fatty acids concentrations in plasma
Time frame: Increased concentration of total short chain fatty acids from baseline concentration at 21 days after the Rhubarb root tea
Changes in short chain fatty acids concentrations in plasma
Time frame: Increased concentration of total short chain fatty acids from baseline concentration at 21 days after the senna tea
Changes in short chain fatty acids concentrations in plasma
Time frame: Increased concentration of total short chain fatty acids from baseline concentration at 21 days after the green tea
Changes in short chain fatty acids concentrations in plasma
Time frame: Increased concentration of total short chain fatty acids after the rhubarb root tea at 21 days compared with the senna tea after 21 days
Changes in short chain fatty acids concentrations in plasma
Time frame: Increased concentration of total short chain fatty acids after the rhubarb root tea at 21 days compared with the green tea after 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TeTrimTeas welsh Herbal tea with rhubarb root, TeTrimTeas welsh Herbal tea with senna and TeTrimTeas welsh Herbal tea with green tea in people with Obesity and Well-being, run by Aberystwyth University at 1 site in United Kingdom.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 May 2023. 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 United Kingdom. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in total plasma Cholesterol after the rhubarb root tea (time frame: Decrease from Baseline plasma Cholesterol after 21 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2023.