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Cognitive and Biological Responses in Stress

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ClinicalTrials.gov Identifier: NCT05026333
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : September 10, 2021
Sponsor:
Collaborator:
Danone Nutricia Research
Information provided by (Responsible Party):
Arpana Gupta, University of California, Los Angeles

Brief Summary:

The goal of this pilot part of the study (Step 1) is to identify the optimal population of high and low anxiety and stress individuals who will differentially respond to a laboratory stress task as measured by changes in subjective stress response (affect), cognition, attention, and biological measures (autonomic and metabolite responses).

Based on experience with different study populations, the investigator's believe that a healthy, homogenous population (Caucasian, women, premenopausal) with higher levels of state anxiety and perceived stress, and with greater responsiveness to laboratory stress tasks (which can also be used in the probiotic intervention study in Step 2) will provide the highest likelihood of identifying the underlying central mechanisms of stress responsiveness in Step 1 and then for the probiotic intervention in Step 2.

For this pilot study, the investigator's will look at baseline measures to determine differences in responses to four subjective (affect/cognition/attention) stress tasks (primary endpoints) and biological (secondary endpoints) measures in a high stress group and a low stress group.

If for Step 1 of the study, the investigator's are able to verify the stratification of the participants into high and low stress groups based on questionnaire data and show differences between participants with high and low perceived stress in psychological characteristics, lab stress tasks and potentially in biological responses, this will help to determine the optimal cut off values, and the optimal stress tasks to be conducted in the planned probiotic intervention study of Step 2.


Condition or disease Intervention/treatment Phase
Stress, Psychological Anxiety Other: Cognitive Stress Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups (high stress/anxiety compared to low stress/anxiety) will be compared on their performance on within laboratory stress and cognitive tasks (4 different tests).
Masking: Single (Participant)
Masking Description: Participants will be blind to which stress/anxiety group they belong to. Researchers will not be blind to the group assignment as group assignment is part of the eligibility criteria for inclusion/enrollment in the study.
Primary Purpose: Basic Science
Official Title: Pilot Study Aimed to Determine the Optimal Design for the UCLA/Danone Probiotic Intervention Study Related to Stress
Actual Study Start Date : June 25, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: High Stress Group
Group of high stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale.
Other: Cognitive Stress Testing
Cognitive and stress study with no product intervention and noninvasive. The high stress/anxiety group will be compared to the low stress/anxiety group in terms of changes from baseline to after the cognitive and stress tests (i.e., 4 laboratory tasks) and metabolite measures.
Other Names:
  • ANS testing
  • metabolites
  • cognitive tasks
  • stress tasks

Experimental: Low Stress Group
Group of low stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale.
Other: Cognitive Stress Testing
Cognitive and stress study with no product intervention and noninvasive. The high stress/anxiety group will be compared to the low stress/anxiety group in terms of changes from baseline to after the cognitive and stress tests (i.e., 4 laboratory tasks) and metabolite measures.
Other Names:
  • ANS testing
  • metabolites
  • cognitive tasks
  • stress tasks




Primary Outcome Measures :
  1. Differences in Subjective Stress Response [ Time Frame: Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours. ]
    Between group differences in pre-and post- of the "overall" negative and positive affect subscale scores from the Positive Affect and Negative Affect Scale (PANAS) administered at baseline immediately before and after the 4 brief and well validated laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.


Secondary Outcome Measures :
  1. Differences in Attention/Executive Function [ Time Frame: Throughout the Color Stroop laboratory test at the in-clinic visit lasting approximately 30 minutes. ]
    Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.

  2. Differences in Emotional Arousal System [ Time Frame: Throughout the IAPS laboratory test during the in-clinic visit lasting approximately 30 minutes. ]
    Between and within group differences in valence and emotional arousal ratings during the IAPS task.

  3. Differences in Subjective Stress Response [ Time Frame: Pre and Post the arithmetic stress task during the in-clinic visit lasting approximately 30 minutes. ]
    Between and within group differences on the negative affect subscale from the Brief Positive Affect and Negative Affect Scale (PANAS) before and after the arithmetic task. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.

  4. Changes in Autonomic Measures - Heart Rate Variability [ Time Frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours. ]
    Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.

  5. Differences in Attention/Executive Function [ Time Frame: Throughout the Trails A & B laboratory tests at the in-clinic visit lasting approximately 30 minutes. ]
    Between and within group differences on the time it takes to complete the Trails A and B attention/executive function lab stress task.

  6. Changes in Autonomic Measures - diastolic and systolic blood pressure [ Time Frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours. ]
    Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.

  7. Changes in Autonomic Measures - Skin Conductance [ Time Frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours. ]
    Between and within group differences in overall average change in skin conductance pre and post each laboratory stress task.


Other Outcome Measures:
  1. Changes in Stress-Related Plasma Metabolite Concentrations as measured via a blood sample and processed by Ixcela for targeted stress-related metabolites. [ Time Frame: Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours. ]
    Between and within group differences in pre- and post- laboratory stress tasks in targeted stress-related metabolite concentrations assessed with the Ixcela Panel and analyzed using a Welch's two-sample t-test to identify overall metabolite changes. Extensive literature details the role of metabolites in modulation of the brain, and widespread effects on excitatory neurotransmission and neuroinflammation. (Metabolites Targeted will include the following pathways: Tryptophan, Purine, Serotonin, Kynurenine, Hypoxanthine, Xanthosine, Xanthine, Guanosine, Guanine, Uric Acid, Methionine, 4-Hydroxy 3-Methoxy Phenylacetic Acid, DL 4-Hydroxy, 3-Methoxy Mandelic Acid, Methoxy Hydroxyphenyl, Glycol, 4HPLA, 2HPAC, 4HPAC).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian
  • Female
  • 18-45 years of age
  • For the high perceived stress group: a PSS score of 15 or higher and a STAI-S of 39 or higher
  • For the low perceived stress group: a PSS score of 8 or lower and a STAI-S score of 24 or lower

Exclusion Criteria:

  • Any ongoing major medical, psychological, or psychiatric conditions and recent changes (3mo) in the use of psychoactive medications or other medications that interfere with the measured outcomes.
  • Medical conditions such as current neurological, cardiovascular, hepatic, renal, autoimmune diseases, diabetes, or cancer. This includes having a current or past within 1 year diagnosis of GI disorders, including but not limited to IBS, IBD, Celiac, or other nutritional deficiency/disease, current eating disorder, or past weight loss surgery.
  • Psychological conditions such as anxiety and depression (I.e., without history of Diagnostic and Statistical Manual (DSM-4) psychiatric diagnosis.
  • Prior/Concomitant Therapy (e.g., Recent changes in the use of psychoactive medications or other medications that interfere with the measured outcomes, as determined by the PI).
  • Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study.
  • Positive test for COVID-19 infection in the past month or if presenting symptoms of COVID-19 infection in the past 2 weeks.

Diet:

  • Participant who changes her dietary habits within the preceding 4 weeks.
  • Participants on probiotics will be asked to wait 1 month before enrollment in the study.
  • Participant with an eating disorder.
  • Participant with special medicated diet (e.g., for obesity, anorexia, metabolic pathology).
  • Participant under artificial nutrition in the last 1 month.
  • Participant planning to modify her dietary habits during the course of the study.

Other Exclusions:

  • Pregnant women or women planning to become pregnant during the study; breast-feeding women based on the interview at screen (Visit 1) and the urine test on day of stress test (Visit 2).
  • Smoker with a moderate to high level of dependence to nicotine (e.g., more than 1/2 a pack of cigarettes a day).
  • Participant consuming regularly more than 3 units of alcohol per day (1 unit = 10mL or 8g).
  • Participants not able to answer questionnaires by writing, whatever the reason.
  • Participant with loos of liberty, by administrative or judicial decision.
  • Participant who is major but with a legal guardian.
  • Participant on antibiotics will be asked to wait 3 months before enrollment in the study.

Medications not Authorized:

  • Opiates/Narcotics
  • Chronic/Daily use of analgesics
  • Anti-seizure meds
  • Antidepressants (5HT3's / Tricyclics etc.) are allowed as long as it's been a stable dose for 3 months
  • Medications for ADD/ADHD (I.e., Adderall)
  • Any medication for appetite suppression
  • Chronic use of laxative/antidiarrheals/medications affecting GI motility
  • Insulin
  • Bile acid sequestrants
  • Use of centrally acting medications that will interfere with CNS testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05026333


Contacts
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Contact: Allison Vaughan, MPH 3108257206 allisonvaughan@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Allison Vaughan, MPH    310-825-7206    allisonvaughan@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Danone Nutricia Research
Investigators
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Principal Investigator: Arpana Gupta, PhD The Regents of the University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Arpana Gupta, University of California, Los Angeles:
Informed Consent Form  [PDF] May 17, 2021

Publications:
Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
International Personality Item Pool: A Scientific Collaboratory for the Development of Advanced Measures of Personality Traits and Other Individual Differences [cited 2020]. Available from: http://ipip.ori.org/.
Cohen S. Perceived stress in a probability sample of the United States. The social psychology of health. Thousand Oaks, CA, US: Sage Publications, Inc; 1988. p. 31-67.
DHQ W-b. Diet History Questionnaire II & Canadian Diet History Questionnaire II: Web-based DHQ. 2021. Available from: https://epi.grants.cancer.gov/dhq2/.
Goldberg LR. A broad-bandwidth, public domain, personality inventory measuring the lower-level facets of several five-factor models. In: Mervielde I, Deary I, De Fruyt F, Ostendorf F, editors. Personality Psychology in Europe. Tilburg, The Netherlands: Tilburg University Press; 1999. p. 7-28.
Goldberg LR, Johnson JA, Eber HW, Hogan R, Ashton R, Cloninger CR, Gough HC. The International Personality Item Pool and the future of public-domain personality measures. Journal of Research in Personality. 2006; 40:84-96.
IPIP. International Personality Item Pool: A Scientific Collaboratory for the Development of Advanced Measures of Personality Traits and Other Individual Differences. 2021. Available from: http://ipip.ori.org/.
Spielberger CD, Gorsuch RL, Lushene R, Vag PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. 1983.

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Responsible Party: Arpana Gupta, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05026333    
Other Study ID Numbers: IRB # 20-001921
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time there is no plan to make the de-identified data available for sharing with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arpana Gupta, University of California, Los Angeles:
stress
women
high stress
low stress
perceived stress
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms