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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
100
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.
University of California, Los Angeles
Los Angeles, California, United States
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.
Time frame: Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours.
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.
Time frame: Throughout the Color Stroop laboratory test at the in-clinic visit lasting approximately 30 minutes.
Differences in Emotional Arousal System
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.
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.
Time frame: Pre and Post the arithmetic stress task during the in-clinic visit lasting approximately 30 minutes.
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.
Time frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
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.
Time frame: Throughout the Trails A & B laboratory tests at the in-clinic visit lasting approximately 30 minutes.
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.
Time frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
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.
Time frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
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