StressNCT06413810
The Effects of a Food Ingredient on Self-reported Stress
A study testing Calmarell in people with Stress, run by Unilever R&D at 1 site in Ireland.
Trial summary
The goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Calmarell
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteIreland
- Study dates
- 15 Jul 2024to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- To be eligible for inclusion, the Participant must fulfil all the following criteria:
- Be able to give written informed consent.
- Be between 18 and 50 years of age.
- Has a BMI between ≥ 18.0 and ≤ 30.0 kg/m2.
- Have moderate stress, as measured on Cohen's Perceived Stress Scale (PSS), with a score between 14 and 26 (inclusive) at both Screening and Baseline Visits.
- Is in general good health, as determined by the investigator.
- Willing to consume the Study Product daily for the duration of the study and comply with the study procedures.
Who cannot join
- The presence of any of the following criteria will exclude the Participant from participating in the study:
- Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) questionnaire.
- Scores ≥10 Patient Health Questionnaire 9 item (PHQ-9).
- Participants who are pregnant or wish to become pregnant during the study.
- Participants who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
Show all 26Show fewer
- Complete abstinence from intercourse two weeks prior to administration of the study product, throughout the human study, until the completion of follow-up procedures or for two weeks following discontinuation of the study product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
- Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
- Is hypersensitive to any of the components of the Study Product.
- Have a significant acute or chronic coexisting illness such as such as uncontrolled hypertension, type 1 or 2 diabetes, cardiovascular diseases or any condition which may, in the opinion of the investigator, impact their ability to participate in the study or impact the study outcomes.
- Use of systemic antibiotics within the 12 weeks prior to Visit 1.
- Use of systemic immunosuppressant drugs, steroids, etc. within the 12 weeks prior to Visit 1.
- Participants diagnosed and treated with prescribed medications for anxiety and depression in the 12 weeks prior to Visit 1.
- Participants who have taken 3 doses laxative or anti-diarrheal medication in the past 12 weeks, at investigator discretion.
- Herbal treatments for mood disorders or psychological conditions (e.g., valerian, St. John's Wort) within 4 weeks prior to Visit 1 or planning to start during the study period.
- Disease such as coeliac disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, gastroesophageal reflux disease (GERD) that by the investigator's judgement, could interfere with the intestinal barrier function or have undergone significant gastrointestinal surgery (appendectomy and cholecystectomy acceptable).
- Participants consuming prebiotics (containing fructans, galacto-oligosaccharides, psyllium husk, inulin as main component), or probiotics within last 4 weeks prior to Visit 1.
- Participants consuming GABA or glutamate supplements, or any other supplements that are thought to directly affect digestive health and mental well-being within 4 weeks prior to Visit 1 which in the opinion of the investigator, impact the study outcomes.
- Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
- Has received treatment involving experimental supplements in the past 4 weeks, at the discretion of the investigator.
- Major changes in lifestyle (i.e., diet, dieting, exercise level, travelling, supplements) for duration of the study.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their immediate family member or a member of their household.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults
The goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product.
Participants will:
- consume both the test and placebo products for 4-weeks each in a randomised order, with 4 weeks in between
- visit the test site 6 times over the 13 weeks
- complete a series of assessments on stress and sleep quality and provide blood, stool and saliva samples
Read the detailed description
A double-blind, randomised, placebo-controlled, crossover study with 6 visits over 13-weeks. Participants will consume study product or placebo for two 4-week intervention periods.
Primary Objective: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on stress.
Secondary Objectives: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on:
- Mood
- Plasma GABA levels
- Salivary cortisol awakening response (CAR)
- Acute effects on stress
- Faecal GABA
- Conditions
- Stress
- Being tested
- Calmarell, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalmarellOther
Food ingredient
PlaceboOther
Blinded placebo
| Study group | Role | What they receive |
|---|---|---|
| Food ingredient | Experimental | Standard food ingredient under investigation Receives: Other: Calmarell |
| Placebo | Placebo comparator | Matched standard food ingredient with no impact Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS) Total Score from baseline to end of intervention
The PSS is a self-reported measure of stress. The questions in this scale ask about participants feelings and thoughts during the last month. Respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. It is a 10-item questionnaire and has a total score which correlates with one of three score categories (low stress [0-13], moderate stress [14-26]and high stress
Measured: 4 weeks
Secondary outcomes (5)
Profile of Mood States Questionnaire (POMS)
POMS is a psychological rating scale used to assess transient, distinct mood states. It has seven subscales, including tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia, confusion-bewilderment, and friendliness. The researcher combines these scores to provide an overall measure called total mood disturbance.
Measured: 4 weeks
Plasma GABA levels
Levels of Gamma-aminobutyric Acid in plasma
Measured: 4 weeks
Salivary cortisol awakening response
- Salivary cortisol awakening response at T0, T30, T45, T60 minutes
Measured: 4 weeks
VAS scale on acute effects on stress
The VAS (visual analogue scale) is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter measured, e.g., the left end = no stress, and the right end = extreme stress
Measured: 30 hours
Faecal GABA quantification
Absolute quantification
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 Jul 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Prof, Principal investigator, Atlantia Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413810
- Sponsor's protocol ID
- AFCRO-177
- Status last verified
- Jan 2025
- First submitted
- 9 May 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults
- ClinicalTrials.gov ID
- NCT06413810
- Acronym / sponsor ID
- AFCRO-177
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 14 May 2024 (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 goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product.
Participants will:
- consume both the test and placebo products for 4-weeks each in a randomised order, with 4 weeks in between
- visit the test site 6 times over the 13 weeks
- complete a series of assessments on stress and sleep quality and provide blood, stool and saliva samples
Detailed description
A double-blind, randomised, placebo-controlled, crossover study with 6 visits over 13-weeks. Participants will consume study product or placebo for two 4-week intervention periods.
Primary Objective: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on stress.
Secondary Objectives: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on:
- Mood
- Plasma GABA levels
- Salivary cortisol awakening response (CAR)
- Acute effects on stress
- Faecal GABA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food ingredient | Experimental | Other: CalmarellStandard food ingredient under investigation |
| Placebo | Placebo comparator | Other: PlaceboMatched standard food ingredient with no impact |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- To be eligible for inclusion, the Participant must fulfil all the following criteria:
Key exclusion criteria (26 listed)
- The presence of any of the following criteria will exclude the Participant from participating in the study:
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 |
|---|---|---|
| CalmarellFood ingredient | Other | Food ingredient |
| PlaceboBlinded placebo | Other | Placebo |
Primary outcome
Change in Perceived Stress Scale (PSS) Total Score from baseline to end of intervention
Time frame: 4 weeks
The PSS is a self-reported measure of stress. The questions in this scale ask about participants feelings and thoughts during the last month. Respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. It is a 10-item questionnaire and has a total score which correlates with one of three score categories (low stress [0-13], moderate stress [14-26]and high stress
5 secondary outcomes
Profile of Mood States Questionnaire (POMS)
Time frame: 4 weeks
Plasma GABA levels
Time frame: 4 weeks
Salivary cortisol awakening response
Time frame: 4 weeks
VAS scale on acute effects on stress
Time frame: 30 hours
Faecal GABA quantification
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Timothy Dinan, Prof principal investigator
Atlantia Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calmarell in people with Stress, run by Unilever R&D at 1 site in Ireland.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 13 Jan 2025. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS) Total Score from baseline to end of intervention (time frame: 4 weeks). 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 13 Jan 2025.