TeTrimTeas: Gut Microbiome and Blood Lipid Markers After Habitual Herbal Tea Consumption
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in total plasma Cholesterol after the rhubarb root tea
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Exclusion Criteria
- •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
- •Play sports at a high level (more than 7h/week or 1h/day)
- •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
排除标准
- 未提供
结局指标
主要结局
Change in total plasma Cholesterol after the rhubarb root tea
时间窗: 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 plasma Low density lipoprotein cholesterol (LDL-C) after the senna tea
时间窗: 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 rhubarb root tea
时间窗: 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 green tea
时间窗: 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
Change in total plasma Cholesterol after the senna tea
时间窗: 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
时间窗: 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
次要结局
- Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the senna tea(Decrease from senna tea plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) 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 Triglycerides after the rhubarb root tea(Decrease from rhubarb root plasma Triglycerides after 21 days when compared with green tea plasma Triglycerides 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)
- Diet choices change measured using the Prime Diet Quality Score(Increased score from the Rhubarb root tea Prime Diet Quality Score at 21 days compared with the green tea at 21 days)
- Change in plasma Triglycerides after the senna tea(Decrease from senna tea plasma Triglycerides after 21 days)
- Change in plasma Triglycerides after the green tea(Decrease from 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(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)
- Change in plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after the green tea(Decrease from green tea plasma non- high-density lipoprotein cholesterol (total cholesterol - high-density lipoprotein cholesterol) after 21 days)
- BMI change measured by weight and height(Decreased score from the Rhubarb root tea BMI at 21 days compared with the green tea at 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)
- Changes in short chain fatty acids concentrations in plasma(Increased concentration of total short chain fatty acids after the rhubarb root tea at 21 days compared with the green tea after 21 days)