NCT05862532

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P50-P75 for early_phase_1 obesity

Timeline
Completed

Started Nov 2022

Shorter than P25 for early_phase_1 obesity

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 17, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 17, 2023

Status Verified

April 1, 2023

Enrollment Period

23 days

First QC Date

April 24, 2023

Last Update Submit

May 15, 2023

Conditions

ObesityWell-being

Keywords

Herbal tea infusionsLipid compositionGut microbiomeShort Chain fatty acidsWell-being

Outcome Measures

Primary Outcomes (10)

  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Increase from Baseline plasma High-Density Lipoprotein cholesterol (HDL-C) after 21 days

  • +25 more secondary outcomes

Study Arms (3)

Welsh Herbal tea with Senna

EXPERIMENTAL

Welsh Herbal tea with green tea and Senna

Dietary Supplement: TeTrimTeas welsh Herbal tea with senna

Welsh Herbal tea with rhubarb root

EXPERIMENTAL

Welsh Herbal tea with green tea and rhubarb root

Dietary Supplement: TeTrimTeas welsh Herbal tea with rhubarb root

Green tea

ACTIVE COMPARATOR

Dartmoor green tea

Dietary Supplement: TeTrimTeas welsh Herbal tea with green tea

Interventions

TeTrimTeas welsh Herbal tea with rhubarb rootDIETARY_SUPPLEMENT

TeTrimTeas welsh Herbal tea with green tea and rhubarb root

Welsh Herbal tea with rhubarb root
TeTrimTeas welsh Herbal tea with sennaDIETARY_SUPPLEMENT

TeTrimTeas welsh Herbal tea with green tea and senna

Welsh Herbal tea with Senna
TeTrimTeas welsh Herbal tea with green teaDIETARY_SUPPLEMENT

TeTrimTeas welsh Herbal tea with green tea

Green tea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Well-being and Health Assessment Research Unit (WARU)

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

SennosidesTea

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Senna ExtractAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsGlycosidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two intervention arms and one placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 17, 2023

Study Start

November 17, 2022

Primary Completion

December 10, 2022

Study Completion

May 31, 2023

Last Updated

May 17, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

No individual participant data (IPD) will be available to other researchers.

Locations

GB(1)