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NCT07871682
Functional Foods for Health
Conditions: Stress, Psychological
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: University of Reading
Location: University of Reading Reading
Summary
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.
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.
Eligibility Criteria
Inclusion Criteria:
Adults aged 18-50 years. PSS-10 score of 14-27, indicating elevated/moderate perceived stress according to the study eligibility criteria.
BMI of 18.5-29.9 kg/m². Able and willing to provide informed consent. Willing and able to comply with all study procedures and requirements.
Exclusion Criteria:
Have a diagnosed vitamin deficiency. Have diabetes. Have heart disease, including a previous stroke or heart attack. Have kidney disease. Have bowel, gastrointestinal, or other gut disease. Have liver disease. Have cancer. Have a diagnosed hormonal abnormality. Have a diagnosed mood disorder, such as depression. Have a diagnosed anxiety disorder, such as generalised anxiety disorder (GAD) or post-traumatic stress disorder (PTSD).
Have taken antibiotics within the previous 3 months. Are pregnant, lactating/breastfeeding, or planning to become pregnant within the next 6 months.
Have a food allergy or intolerance that would prevent them from consuming the study products.
Are taking medications for anaemia, high blood pressure, high blood fats, inflammatory conditions, or depression.
Are actively attempting to lose weight. Are currently using weight-loss injections, such as Wegovy (semaglutide) or Mounjaro (tirzepatide).
Have participated in another intervention study within the previous month. Are currently regularly consuming prebiotic or probiotic supplements, or have regularly consumed these supplements within the previous 3 months.
Do not meet the study requirements or are unable/unwilling to comply with study procedures.
Source: ClinicalTrials.gov (NCT07871682). StuddyBuddy aggregates publicly available trial information.