Gut microbiome and blood markers after habitual herbal tea consumption (SRTT)

Not Applicable

Completed

• Conditions: Overweight individuals, high BMI; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN32761538
• Lead Sponsor: Welsh Government

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-10
• Study Start: 2023-05-02
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change in gut microbiome between arms and between pre and post intervention measured using 16S rRNA Amplicon Sequencing in stools<br> 2. Change in diet score between arms and between pre and post intervention measured using the Prime Diet Quality Score (PDQS) questionnaire<br> 3. Change in stool score (using the Bristol stool score) between arms and between pre and post intervention<br> 4. Change in weight/BMI/waist: hip between arms and between pre and post intervention<br> 5. Change in concentration of short chain fatty acids between arms and between pre and post intervention measured using GC-FID<br>