Seaweed Study
Assessing the effects of a novel seaweed-containing functional food product on Stress-Associated Immune and Gut Health Outcomes
Background to the study
The gut plays an important role in supporting the immune system, and certain dietary components such as probiotics (beneficial bacteria) and prebiotics (fibres that feed beneficial bacteria) can help to maintain gut and immune health. Alginate is a natural fibre extracted from brown seaweed that is widely used in foods which may help support beneficial gut bacteria and regulate inflammation. Ongoing psychological stress is known to affect immune function and increase inflammation in the body. This study will investigate whether a daily jelly containing alginate support gut health and improve immune responses compared to a placebo in adults experiencing higher levels of chronic stress.
What is the purpose of this study
We are recruiting participants with elevated chronic stress to assess whether a functional jelly containing alginate, can help to reduce markers of inflammation, by mediating a change in gut microbiota composition.
Who can take part in this study?
The study will aim to recruit 40 participants between the ages of 18 and 50 years with elevated stress levels measured using the perceived stress scale 10 questionnaire (PSS-10), and a BMI between 18.5-29.9 kg/m2, otherwise in general good health.
Exclusion criteria
You are not eligible to take part in the study if any of the following applies to you:
- Diagnosed with vitamin deficiencies, diabetes, heart disease (previous stroke or heart attack), kidney, bowel or liver or gastrointestinal (gut) diseases, cancer or hormone abnormalities, mood disorders e.g. depression or anxiety disorders e.g. PTSD.
- Currently taking or have taken antibiotics in the last in the last 3 months.
- Participants who are pregnant or planning a pregnancy within the next six months, lactating or breastfeeding.
- Participants with food allergies or intolerances.
- Participants who are currently regularly consuming prebiotic or probiotic supplements or have in the last 3 months.
- On certain types of medication (e.g. for anaemia, high blood pressure, high blood fats, inflammatory conditions and depression).
- Participants who are actively trying to lose weight, using weight loss injections (e.g. Wegovy and Mounjaro).
Volunteers who have participated in another intervention study in the last month will be also excluded.
What will taking part in the study involve?
The study involves 1 screening meeting in person and 4 visits to the Department of Food and Nutritional Sciences (FNS), over a period of three months. This study involves four blood sample donations, four stool and urine samples, and completion of Perceived Stress Scale 10 (PSS-10), Bristol stool chart, and 24 hour food intake questionnaires online before each visit. Additionally, completion of Wisconsin Upper Respiratory Symptom Surveys daily.
Screening visit
Volunteers interested in taking part in the study, will complete the Medical and Lifestyle questionnaire via REDCap, an online platform. Following this, participants will be required to attend an in person screening at the Harry Nursten building at the University of Reading. During the screening visit, the full extent of your involvement in the study will be explained and you will be given the opportunity to ask any questions you may have, before giving informed consent either online using REDCap or on a paper form. Your height and weight will be measured to calculate BMI and you will be asked to complete the PSS-10 and Recent Life Events (RLEQ) questionnaires online.
Preparation for study visits
We ask that you continue consuming your usual diet, to exercise normally and continue usual activities. If you begin taking antibiotics or have a change in medication, please inform the researchers as soon as possible. We ask that you refrain from taking other probiotic supplements, and prebiotics.
Before each visit:
Prior to any study visits, please do not consume caffeine (e.g. coffee, tea, energy drinks etc.), or exercise prior to coming in on the day of the study visit.
Main study visits
4 study visits 28 days apart.
Study contact
Please contact h.sedgwick@pgr.reading.ac.uk for more information about this study.