The Effects of a Food Ingredient on Self-reported Stress

NCT06413810 | Completed

• 1 other identifier: AFCRO-177
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (5)

• Profile of Mood States Questionnaire (POMS)

  4 weeks

• Plasma GABA levels

  4 weeks

• Salivary cortisol awakening response

  4 weeks

• VAS scale on acute effects on stress

  30 hours

• Faecal GABA quantification

  4 weeks

Study Arms (2)

Food ingredient

EXPERIMENTAL

Standard food ingredient under investigation

Other: Calmarell

Placebo

PLACEBO COMPARATOR

Matched standard food ingredient with no impact

Other: Placebo

Interventions

Calmarell OTHER

Food ingredient

Food ingredient

Placebo OTHER

Blinded placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, Co Cork, T23 R50R, Ireland

Location

Study Officials

• Timothy Dinan, Prof

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: July 15, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)