An Early Phase 1 interventional study of TeTrimTeas welsh Herbal tea with rhubarb root and TeTrimTeas welsh Herbal tea with senna in Obesity and Well-being, sponsored by Aberystwyth University. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Aberystwyth University · Early Phase 1, Interventional, and Supportive care
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 55 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Aberystwyth University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria
Food allergy /food intolerance/ eating disorder or are on a specially prescribed diet
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Welsh Herbal tea with green tea and Senna
Dietary Supplement: TeTrimTeas welsh Herbal tea with senna
Welsh Herbal tea with green tea and rhubarb root
Dietary Supplement: TeTrimTeas welsh Herbal tea with rhubarb root
Dartmoor green tea
Dietary Supplement: TeTrimTeas welsh Herbal tea with green tea
TeTrimTeas welsh Herbal tea with green tea and rhubarb root
TeTrimTeas welsh Herbal tea with green tea and senna
TeTrimTeas welsh Herbal tea with green tea
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
Time frame: 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
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 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
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 plasma Cholesterol after the senna tea
Change in total Cholesterol (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
Time frame: 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
Time frame: 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
Time frame: 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
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 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
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 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
Time frame: 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
Time frame: Decrease from Baseline plasma Low density lipoprotein cholesterol (LDL-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
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
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
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
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
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
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the senna tea measured in capillary bloods using AFINION S100
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
Change in High-Density Lipoprotein cholesterol (HDL-C) (mmol/L) after the green tea measured in capillary bloods using AFINION S100
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Change in Triglycerides (mmol/L) after the rhubarb root tea measured in capillary bloods using AFINION S100
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
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
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
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
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
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
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
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
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
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
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
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.
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
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.
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
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.
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
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.
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
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.
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
BMI change measured by weight and height will be combined to report BMI in kg/m\^2
Time frame: 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
Time frame: 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
Time frame: 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
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
BMI change measured by weight and height will be combined to report BMI in kg/m\^2
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
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
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
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
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
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
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
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
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
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection
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
Plan to share: No — No individual participant data (IPD) will be available to other researchers.
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Aberystwyth University