Functional Foods for Health
ConditionStress, Psychological
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Reading
About this trial
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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Sodium alginate
Dietary supplement5g/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)
Placebo (maltodextrin)
Dietary supplement2g/d maltodextrin within a jelly matrix ( A placebo flavour and kcal matched jelly given each day containing no sodium alginate)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Alginate-First SequenceOther 2 interventions
Group B: Placebo-First SequenceOther 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
Difference in plasma inflammatory marker concentrations between alginate intervention and placebo after 28 days
Plasma concentrations of IL-10, TNF-a, IL-1b and 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.
Time frame
From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: