An interventional study of Sodium alginate and Placebo (maltodextrin) in Stress, Psychological, sponsored by University of Reading. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Reading · Not applicable, Interventional, and Prevention
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.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's planned enrollment of 40 is below the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
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Participants receive the alginate intervention for 28 days, followed by a 28-day washout period and then placebo for 28 days.
Dietary Supplement: Sodium alginate · Dietary Supplement: Placebo (maltodextrin)
Participants receive placebo for 28 days, followed by a 28-day washout period and then the alginate intervention for 28 days.
Dietary Supplement: Sodium alginate · Dietary Supplement: Placebo (maltodextrin)
5g/d sodium alginate within a jelly matrix (5g/d of sodium alginate given as a single serving of flavoured jelly containing the sodium alginate each day)
2g/d maltodextrin within a jelly matrix ( A placebo flavour and kcal matched jelly given each day containing no sodium alginate)
Difference in plasma interleukin-6 (IL-6) concentration between alginate intervention and placebo after 28 days
Plasma interleukin-6 (IL-6) concentration will be measured in plasma from blood samples collected at the end of each 28-day treatment period using a Simple Plex Assay. IL-6 concentration following the alginate intervention will be compared with IL-6 concentration following the placebo period.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in gut microbiota composition between alginate and placebo after 28 days
Gut microbiota composition will be assessed from stool samples collected at the end of each 28-day treatment period using 16S sequencing combined with Bacterial Enumerations by FISH-FCM (Fluorescence In Situ Hybridisation with Flow Cytometry). The composition and relative abundance of bacterial taxa following the alginate intervention will be compared with those following the placebo period.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in faecal calprotectin concentration between alginate intervention and placebo after 28 days
Faecal calprotectin concentration will be measured from stool samples collected at the end of each 28-day treatment period. Calprotectin concentration following the alginate intervention will be compared with that following the placebo period.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in urinary metabolic profile between alginate intervention and placebo after 28 days
Urine samples collected at the end of each 28-day treatment period will be analysed using proton nuclear magnetic resonance (¹H-NMR) spectroscopy to characterise the urinary metabolic profile. The metabolic profiles following the alginate intervention will be compared with those following the placebo period.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Change in perceived stress score between alginate intervention and placebo after 28 days
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 produces a total score ranging from 0 to 40, with higher scores indicating greater perceived stress. The change in PSS-10 score from the start to the end of each 28-day treatment period will be compared between the alginate and placebo periods.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in upper respiratory symptom frequency and severity between alginate intervention and placebo
Upper respiratory symptoms will be assessed using the Wisconsin Upper Respiratory Symptom Survey (WURSS), completed by participants during each 28-day treatment period. The frequency and severity of self-reported upper respiratory symptoms during the alginate intervention will be compared with those during the placebo period. The score each day will be 0 - 161 depending on symptom severity with higher scores indicating higher severity.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in plasma inflammatory marker IL-10 concentrations between alginate intervention and placebo after 28 days
Plasma concentrations of IL-10 using an automated ELISA platform Ella will be measured from blood samples collected at the end of each 28-day treatment period. Concentrations following the alginate intervention will be compared with those following the placebo period in pg/mL.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in plasma inflammatory marker TNF-a concentrations between alginate intervention and placebo after 28 days
Plasma concentrations of TNF-a using an automated ELISA platform Ella will be measured from blood samples collected at the end of each 28-day treatment period. Concentrations following the alginate intervention will be compared with those following the placebo period in pg/mL.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in plasma inflammatory marker IL-1b concentrations between alginate intervention and placebo after 28 days
Plasma concentrations of IL-1b using an automated ELISA platform Ella will be measured from blood samples collected at the end of each 28-day treatment period. Concentrations following the alginate intervention will be compared with those following the placebo period in pg/mL.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Difference in plasma C- reactive protein concentrations between alginate intervention and placebo after 28 days
Plasma concentrations of C- reactive protein using an automated ELISA platform Ella will be measured from blood samples collected at the end of each 28-day treatment period. Concentrations following the alginate intervention will be compared with those following the placebo period in pg/mL.
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Alginates