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Cognitive and Biological Responses in Stress

Primary Purpose

Stress, Psychological, Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Stress Testing

About this trial

This is an interventional basic science trial for Stress, Psychological focused on measuring stress, women, high stress, low stress, perceived stress

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High Stress Group

Low Stress Group

Arm Description

Group of high stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale.

Group of low stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale.

Outcomes

Primary Outcome Measures

Differences in Subjective Stress Response

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

Differences in Attention/Executive Function

Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.

Differences in Emotional Arousal System

Between and within group differences in valence and emotional arousal ratings during the IAPS task.

Differences in Subjective Stress Response

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.

Changes in Autonomic Measures - Heart Rate Variability

Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.

Differences in Attention/Executive Function

Between and within group differences on the time it takes to complete the Trails A and B attention/executive function lab stress task.

Changes in Autonomic Measures - diastolic and systolic blood pressure

Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.

Changes in Autonomic Measures - Skin Conductance

Between and within group differences in overall average change in skin conductance pre and post each laboratory stress task.

Full Information

NCT ID

NCT05026333

First Posted

August 10, 2021

Last Updated

October 10, 2022

Sponsor

University of California, Los Angeles

Collaborators

Danone Nutricia Research

1. Study Identification

Unique Protocol Identification Number

NCT05026333

Brief Title

Cognitive and Biological Responses in Stress

Official Title

Pilot Study Aimed to Determine the Optimal Design for the UCLA/Danone Probiotic Intervention Study Related to Stress

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 25, 2021 (Actual)

Primary Completion Date

July 15, 2022 (Actual)

Study Completion Date

July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

Danone Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Psychological, Anxiety

Keywords

stress, women, high stress, low stress, perceived stress

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Stress Group

Arm Type

Experimental

Arm Description

Group of high stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale.

Arm Title

Low Stress Group

Arm Type

Experimental

Arm Description

Group of low stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale.

Intervention Type

Other

Intervention Name(s)

Cognitive Stress Testing

Other Intervention Name(s)

ANS testing, metabolites, cognitive tasks, stress tasks

Intervention Description

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.

Primary Outcome Measure Information:

Title

Differences in Subjective Stress Response

Description

Time Frame

Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours.

Secondary Outcome Measure Information:

Title

Differences in Attention/Executive Function

Description

Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.

Time Frame

Throughout the Color Stroop laboratory test at the in-clinic visit lasting approximately 30 minutes.

Title

Differences in Emotional Arousal System

Description

Between and within group differences in valence and emotional arousal ratings during the IAPS task.

Time Frame

Throughout the IAPS laboratory test during the in-clinic visit lasting approximately 30 minutes.

Title

Differences in Subjective Stress Response

Description

Time Frame

Pre and Post the arithmetic stress task during the in-clinic visit lasting approximately 30 minutes.

Title

Changes in Autonomic Measures - Heart Rate Variability

Description

Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.

Time Frame

Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.

Title

Differences in Attention/Executive Function

Description

Between and within group differences on the time it takes to complete the Trails A and B attention/executive function lab stress task.

Time Frame

Throughout the Trails A & B laboratory tests at the in-clinic visit lasting approximately 30 minutes.

Title

Changes in Autonomic Measures - diastolic and systolic blood pressure

Description

Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.

Time Frame

Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.

Title

Changes in Autonomic Measures - Skin Conductance

Description

Between and within group differences in overall average change in skin conductance pre and post each laboratory stress task.

Time Frame

Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.

Other Pre-specified Outcome Measures:

Title

Changes in Stress-Related Plasma Metabolite Concentrations as measured via a blood sample and processed by Ixcela for targeted stress-related metabolites.

Description

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).

Time Frame

Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arpana Gupta, PhD

Organizational Affiliation

The Regents of the University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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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