Stress, PsychologicalNCT07871682
Functional Foods for Health
A study testing Sodium alginate in people with Stress, Psychological, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Sodium alginate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Reading
Reading
Anisha Wijeyesekera, +44 (0) 118 378 6648, a.wijeyesekera@reading.ac.uk
Holly Sedgwick, 07535535260, H.sedgwick@pgr.reading.ac.uk
About this study
Official title: Assessing the Effects of a Novel Seaweed-containing Functional Food Product on Stress-Associated Immune and Gut Health Outcomes
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.
- Conditions
- Stress, Psychological
- Being tested
- Sodium alginate, Placebo (maltodextrin)
- Keywords
- Perceived stress, alginate, chronic stress, inflammation, microbiome
- Medical subject headings
- Stress, Psychological, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium alginateDietary supplement
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)
Placebo (maltodextrin)Dietary supplement
2g/d maltodextrin within a jelly matrix ( A placebo flavour and kcal matched jelly given each day containing no sodium alginate)
| Study group | Role | What they receive |
|---|---|---|
| Alginate-First Sequence | Other | Participants receive the alginate intervention for 28 days, followed by a 28-day washout period and then placebo for 28 days. Receives: Dietary Supplement: Sodium alginate; Dietary Supplement: Placebo (maltodextrin) |
| Placebo-First Sequence | Other | Participants receive placebo for 28 days, followed by a 28-day washout period and then the alginate intervention for 28 days. Receives: Dietary Supplement: Sodium alginate; Dietary Supplement: Placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-blind, randomised, placebo-controlled crossover study. Participants will be randomly assigned to one of two treatment sequences. Group 1 will receive the intervention for 28 days, followed by a 28-day washout period and then the placebo for 28 days. Group 2 will receive the placebo for 28 days, followed by a 28-day washout period and then the intervention for 28 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisha Wijeyesekera, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871682
- Sponsor's protocol ID
- UREC 26/18
- Other IDs
- BB/T008776/1
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Novel Seaweed-containing Functional Food Product on Stress-Associated Immune and Gut Health Outcomes
- ClinicalTrials.gov ID
- NCT07871682
- Acronym / sponsor ID
- UREC 26/18
- Conditions
- Stress, Psychological
- Keywords
- Perceived stress, alginate, chronic stress, inflammation, microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blind, randomised, placebo-controlled crossover study. Participants will be randomly assigned to one of two treatment sequences. Group 1 will receive the intervention for 28 days, followed by a 28-day washout period and then the placebo for 28 days. Group 2 will receive the placebo for 28 days, followed by a 28-day washout period and then the intervention for 28 days.
| Arm | Type | Receives |
|---|---|---|
| Alginate-First Sequence | Other | Dietary Supplement: Sodium alginate, Dietary Supplement: Placebo (maltodextrin)Participants receive the alginate intervention for 28 days, followed by a 28-day washout period and then placebo for 28 days. |
| Placebo-First Sequence | Other | 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium alginate5g/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) | Dietary supplement | Alginate-First Sequence, Placebo-First Sequence |
| Placebo (maltodextrin)2g/d maltodextrin within a jelly matrix ( A placebo flavour and kcal matched jelly given each day containing no sodium alginate) | Dietary supplement | Alginate-First Sequence, Placebo-First Sequence |
Primary outcome
Difference in plasma interleukin-6 (IL-6) concentration between alginate intervention and placebo after 28 days
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 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.
9 secondary outcomes
Difference in gut microbiota composition between alginate and placebo after 28 days
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
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
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
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
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
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
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
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
Time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium alginate in people with Stress, Psychological, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anisha Wijeyesekera (+44 (0) 118 378 6648, a.wijeyesekera@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in plasma interleukin-6 (IL-6) concentration between alginate intervention and placebo after 28 days (time frame: From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.