The effects on asthma of dietary supplements that induce the growth or activity of beneficial microorganisms.
- Conditions
- Asthma, steps 1-4 according to the Birtish Thoracic Society Guidelines (BTS)Respiratory
- Registration Number
- ISRCTN11358769
- Lead Sponsor
- ottingham Trent University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 14
1.18-50 years of age at the date of your first visit.
2. Body mass index (BMI) of 18.5-25 kg·m2 (we can work this out for you using your height and body weight).
3. Non-smoker.
4. Asthma is defined as Steps 1 to 4 based on British Thoracic Society guidelines.
5. On a stable asthma treatment for 3 months
6. Current medication prescription from your GP if diagnosed with asthma (e.g. maintenance and reliever inhalers).
7. Be able and willing to follow all trial requirements.
8. Disclose any nutritional supplements you take to the researcher, to determine whether these may be considered as ‘exclusion criteria’.
1. Suffer from asthma but do not have a current medication prescription from your GP (e.g. maintenance and reliever inhalers).
2. Regularly consume Omega-3 supplements, and/or eat high levels of Omega-3 (e.g. more than 1-2 portions of oily fish such as salmon or mackerel a week).
3. Take aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen once a day on 5 of of the 7 days of the week.
4. Pregnant or planning a pregnancy during the time of the study (on each visit you will be asked to complete a pregnancy test if you are within childbearing age).
5. Consumed prebiotics and/or probiotics (supplements), drugs that affect gastrointestinal mobility or laxatives in the 4 weeks before signing the consent form.
6. Daily dose of anti-histamine, which you could not temporarily avoid for 72 hours before each testing session without exacerbation of symptoms.
7. Vegetarian or vegan diet.
8. Previously diagnosed with chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, or similar respiratory (breathing-related) illness.
9. Admitted to hospital during the past 12 months for your asthma.
10. History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart disease.
11. History of recurrent chest infections.
12. Acute infection in the last four weeks, and/or major operation in the past four months.
13. History of gastrointestinal drug reaction.
14. Taken antibiotics in the past 3 months.
15. History or current evidence of gastrointestinal disease (e.g. chronic constipation, diarrhoea, irritable bowel syndrome, Chrohn’s disease).
16. Recently taken part in other research projects. Please notify the chief investigator.
17. Lactose intolerant.
18. Regularly take antioxidant supplements, such as beta-carotene, vitamin A, vitamin C, vitamin E, lutein and selenium. Standard multivitamin and mineral supplements are acceptable; however, If a single antioxidant supplement (e.g. Vitamin C), is more than the recommended daily DRV’s this must be checked with the chief investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in FOXP3 expression by regulatory T cells in adults with asthma, following a prebiotic intervention crossover trial. Measured using flow cytometry at 4 timepoints as aforementioned, baseline, prebiotic, washout and placebo.
- Secondary Outcome Measures
Name Time Method <br> 1. Changes in asthma control, and frequency of reliever medication in adults with asthma following prebiotic supplementation. Measured at 4 time points, baseline, prebiotic, washout and placebo; using the Asthma Control Questionnaire.<br> 2. Changes in perception of asthma control (e.g. reduced frequency/severity of symptoms) following prebiotic supplementation. Measured at 4 time points, baseline, prebiotic, washout and placebo; using the Asthma Control Test.<br> 3. Changes in quality of life following prebiotic supplementation. Measured at 4 time points, baseline, prebiotic, washout and placebo; using the Asthma Quality of Life Questionnaire<br>