Cognitive and Biological Responses in Stress

NCT05026333 | Completed

• 1 other identifier: IRB # 20-001921
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Anxiety

Keywords

stress; women; high stress; low stress; perceived stress

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

• Differences in Attention/Executive Function

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

• Differences in Emotional Arousal System

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

• Differences in Subjective Stress Response

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

• Changes in Autonomic Measures - Heart Rate Variability

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

• Differences in Attention/Executive Function

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

Other Outcomes (1)

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

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

Study Arms (2)

High Stress Group

EXPERIMENTAL

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

Low Stress Group

EXPERIMENTAL

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

Interventions

Cognitive Stress Testing OTHER

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.

Also known as: ANS testing, metabolites, cognitive tasks, stress tasks

High Stress Group; Low Stress Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian
• Female
• 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

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (62)

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Berthoud HR. Interactions between the "cognitive" and "metabolic" brain in the control of food intake. Physiol Behav. 2007 Aug 15;91(5):486-98. doi: 10.1016/j.physbeh.2006.12.016. Epub 2007 Jan 12.

  PMID: 17307205 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Murphy KJ, Hodges TE, Sheppard PAS, Troyer AK, Hampson E, Galea LAM. Sex differences in cortisol and memory following acute social stress in amnestic mild cognitive impairment. J Clin Exp Neuropsychol. 2020 Nov;42(9):881-901. doi: 10.1080/13803395.2020.1825633. Epub 2020 Oct 6.

  PMID: 33023371 BACKGROUND

• Helminen EC, Morton ML, Wang Q, Felver JC. Stress Reactivity to the Trier Social Stress Test in Traditional and Virtual Environments: A Meta-Analytic Comparison. Psychosom Med. 2021 Apr 1;83(3):200-211. doi: 10.1097/PSY.0000000000000918.

  PMID: 33534392 BACKGROUND

• Wheelock MD, Goodman AM, Harnett NG, Wood KH, Mrug S, Granger DA, Knight DC. Sex-related Differences in Stress Reactivity and Cingulum White Matter. Neuroscience. 2021 Apr 1;459:118-128. doi: 10.1016/j.neuroscience.2021.02.014. Epub 2021 Feb 13.

  PMID: 33588003 BACKGROUND

• Olfert MD, Barr ML, Charlier CC, Greene GW, Zhou W, Colby SE. Sex Differences in Lifestyle Behaviors among U.S. College Freshmen. Int J Environ Res Public Health. 2019 Feb 7;16(3):482. doi: 10.3390/ijerph16030482.

  PMID: 30736399 BACKGROUND

• Luque B, Castillo-Mayen R, Cuadrado E, Gutierrez-Domingo T, Rubio SJ, Arenas A, Delgado-Lista J, Perez Martinez P, Tabernero C. The Role of Emotional Regulation and Affective Balance on Health Perception in Cardiovascular Disease Patients According to Sex Differences. J Clin Med. 2020 Sep 30;9(10):3165. doi: 10.3390/jcm9103165.

  PMID: 33007817 BACKGROUND

• Marin IA, Goertz JE, Ren T, Rich SS, Onengut-Gumuscu S, Farber E, Wu M, Overall CC, Kipnis J, Gaultier A. Microbiota alteration is associated with the development of stress-induced despair behavior. Sci Rep. 2017 Mar 7;7:43859. doi: 10.1038/srep43859.

  PMID: 28266612 BACKGROUND

• Schneider TR, Rench TA, Lyons JB, Riffle RR. The influence of neuroticism, extraversion and openness on stress responses. Stress Health. 2012 Apr;28(2):102-10. doi: 10.1002/smi.1409. Epub 2011 Jun 15.

  PMID: 22281953 BACKGROUND

• Cohen S, Janicki-Deverts D, Doyle WJ, Miller GE, Frank E, Rabin BS, Turner RB. Chronic stress, glucocorticoid receptor resistance, inflammation, and disease risk. Proc Natl Acad Sci U S A. 2012 Apr 17;109(16):5995-9. doi: 10.1073/pnas.1118355109. Epub 2012 Apr 2.

  PMID: 22474371 BACKGROUND

• Villada C, Hidalgo V, Almela M, Salvador A. Individual Differences in the Psychobiological Response to Psychosocial Stress (Trier Social Stress Test): The Relevance of Trait Anxiety and Coping Styles. Stress Health. 2016 Apr;32(2):90-9. doi: 10.1002/smi.2582. Epub 2014 Jun 11.

  PMID: 24916722 BACKGROUND

• Walter S, Kessler H, Gruss S, Jerg-Bretzke L, Scheck A, Strobel J, Hoffmann H, Traue HC. The influence of neuroticism and psychological symptoms on the assessment of images in three-dimensional emotion space. Psychosoc Med. 2011;8:Doc04. doi: 10.3205/psm000073. Epub 2011 Jun 6.

  PMID: 21698089 BACKGROUND

• Crow AJD. Associations Between Neuroticism and Executive Function Outcomes: Response Inhibition and Sustained Attention on a Continuous Performance Test. Percept Mot Skills. 2019 Aug;126(4):623-638. doi: 10.1177/0031512519848221. Epub 2019 May 30.

  PMID: 31146642 BACKGROUND

• Craske MG, Waters AM, Nazarian M, Mineka S, Zinbarg RE, Griffith JW, Naliboff B, Ornitz EM. Does neuroticism in adolescents moderate contextual and explicit threat cue modulation of the startle reflex? Biol Psychiatry. 2009 Feb 1;65(3):220-6. doi: 10.1016/j.biopsych.2008.07.020. Epub 2008 Sep 11.

  PMID: 18789433 BACKGROUND

• Naliboff BD, Waters AM, Labus JS, Kilpatrick L, Craske MG, Chang L, Negoro H, Ibrahimovic H, Mayer EA, Ornitz E. Increased acoustic startle responses in IBS patients during abdominal and nonabdominal threat. Psychosom Med. 2008 Oct;70(8):920-7. doi: 10.1097/PSY.0b013e318186d858. Epub 2008 Oct 8.

  PMID: 18842745 BACKGROUND

• Weng YJ, Gan HY, Li X, Huang Y, Li ZC, Deng HM, Chen SZ, Zhou Y, Wang LS, Han YP, Tan YF, Song YJ, Du ZM, Liu YY, Wang Y, Qin N, Bai Y, Yang RF, Bi YJ, Zhi FC. Correlation of diet, microbiota and metabolite networks in inflammatory bowel disease. J Dig Dis. 2019 Sep;20(9):447-459. doi: 10.1111/1751-2980.12795. Epub 2019 Aug 1.

  PMID: 31240835 BACKGROUND

• Floegel A, Wientzek A, Bachlechner U, Jacobs S, Drogan D, Prehn C, Adamski J, Krumsiek J, Schulze MB, Pischon T, Boeing H. Linking diet, physical activity, cardiorespiratory fitness and obesity to serum metabolite networks: findings from a population-based study. Int J Obes (Lond). 2014 Nov;38(11):1388-96. doi: 10.1038/ijo.2014.39. Epub 2014 Mar 10.

  PMID: 24608922 BACKGROUND

• Yamada T, Takahashi D, Hase K. The diet-microbiota-metabolite axis regulates the host physiology. J Biochem. 2016 Jul;160(1):1-10. doi: 10.1093/jb/mvw022. Epub 2016 Mar 11.

  PMID: 26970281 BACKGROUND

• Rhee SH, Pothoulakis C, Mayer EA. Principles and clinical implications of the brain-gut-enteric microbiota axis. Nat Rev Gastroenterol Hepatol. 2009 May;6(5):306-14. doi: 10.1038/nrgastro.2009.35.

  PMID: 19404271 BACKGROUND

• Galley JD, Bailey MT. Impact of stressor exposure on the interplay between commensal microbiota and host inflammation. Gut Microbes. 2014 May-Jun;5(3):390-6. doi: 10.4161/gmic.28683. Epub 2014 Apr 1.

  PMID: 24690880 BACKGROUND

• Goyal N, Shukla G. Probiotic Lactobacillus rhamnosus GG modulates the mucosal immune response in Giardia intestinalis-infected BALB/c mice. Dig Dis Sci. 2013 May;58(5):1218-25. doi: 10.1007/s10620-012-2503-y. Epub 2012 Dec 21.

  PMID: 23263901 BACKGROUND

• Thomas CM, Hong T, van Pijkeren JP, Hemarajata P, Trinh DV, Hu W, Britton RA, Kalkum M, Versalovic J. Histamine derived from probiotic Lactobacillus reuteri suppresses TNF via modulation of PKA and ERK signaling. PLoS One. 2012;7(2):e31951. doi: 10.1371/journal.pone.0031951. Epub 2012 Feb 22.

  PMID: 22384111 BACKGROUND

• Schwarcz R, Bruno JP, Muchowski PJ, Wu HQ. Kynurenines in the mammalian brain: when physiology meets pathology. Nat Rev Neurosci. 2012 Jul;13(7):465-77. doi: 10.1038/nrn3257.

  PMID: 22678511 BACKGROUND

• Bischoff SC, Barbara G, Buurman W, Ockhuizen T, Schulzke JD, Serino M, Tilg H, Watson A, Wells JM. Intestinal permeability--a new target for disease prevention and therapy. BMC Gastroenterol. 2014 Nov 18;14:189. doi: 10.1186/s12876-014-0189-7.

  PMID: 25407511 BACKGROUND

• Clarke G, Fitzgerald P, Cryan JF, Cassidy EM, Quigley EM, Dinan TG. Tryptophan degradation in irritable bowel syndrome: evidence of indoleamine 2,3-dioxygenase activation in a male cohort. BMC Gastroenterol. 2009 Jan 20;9:6. doi: 10.1186/1471-230X-9-6.

  PMID: 19154614 BACKGROUND

• Mawe GM, Hoffman JM. Serotonin signalling in the gut--functions, dysfunctions and therapeutic targets. Nat Rev Gastroenterol Hepatol. 2013 Aug;10(8):473-86. doi: 10.1038/nrgastro.2013.105. Epub 2013 Jun 25.

  PMID: 23797870 BACKGROUND

• Gershon MD, Tack J. The serotonin signaling system: from basic understanding to drug development for functional GI disorders. Gastroenterology. 2007 Jan;132(1):397-414. doi: 10.1053/j.gastro.2006.11.002.

  PMID: 17241888 BACKGROUND

• Elsenbruch S. How positive and negative expectations shape the experience of visceral pain. Handb Exp Pharmacol. 2014;225:97-119. doi: 10.1007/978-3-662-44519-8_6.

  PMID: 25304528 BACKGROUND

• Aizawa E, Sato Y, Kochiyama T, Saito N, Izumiyama M, Morishita J, Kanazawa M, Shima K, Mushiake H, Hongo M, Fukudo S. Altered cognitive function of prefrontal cortex during error feedback in patients with irritable bowel syndrome, based on FMRI and dynamic causal modeling. Gastroenterology. 2012 Nov;143(5):1188-1198. doi: 10.1053/j.gastro.2012.07.104. Epub 2012 Jul 27.

  PMID: 22841782 BACKGROUND

• Kennedy PJ, Clarke G, O'Neill A, Groeger JA, Quigley EM, Shanahan F, Cryan JF, Dinan TG. Cognitive performance in irritable bowel syndrome: evidence of a stress-related impairment in visuospatial memory. Psychol Med. 2014 May;44(7):1553-66. doi: 10.1017/S0033291713002171. Epub 2013 Aug 29.

  PMID: 23985155 BACKGROUND

• Tanaka Y, Kanazawa M, Fukudo S, Drossman DA. Biopsychosocial model of irritable bowel syndrome. J Neurogastroenterol Motil. 2011 Apr;17(2):131-9. doi: 10.5056/jnm.2011.17.2.131. Epub 2011 Apr 27.

  PMID: 21602989 BACKGROUND

• Renaud P, Blondin JP. The stress of Stroop performance: physiological and emotional responses to color-word interference, task pacing, and pacing speed. Int J Psychophysiol. 1997 Sep;27(2):87-97. doi: 10.1016/s0167-8760(97)00049-4.

  PMID: 9342640 BACKGROUND

• Douchamps J. A brief, versatile, computerized, stress-inducing task derived from the Stroop color word test. Methods Find Exp Clin Pharmacol. 1988 Sep;10(9):595-601.

  PMID: 3226226 BACKGROUND

• Sugg MJ, McDonald JE. Time course of inhibition in color-response and word-response versions of the Stroop task. J Exp Psychol Hum Percept Perform. 1994 Jun;20(3):647-75. doi: 10.1037//0096-1523.20.3.647.

  PMID: 8027716 BACKGROUND

• Corrigan JD, Hinkeldey NS. Relationships between parts A and B of the Trail Making Test. J Clin Psychol. 1987 Jul;43(4):402-9. doi: 10.1002/1097-4679(198707)43:43.0.co;2-e.

  PMID: 3611374 BACKGROUND

• Gaudino EA, Geisler MW, Squires NK. Construct validity in the Trail Making Test: what makes Part B harder? J Clin Exp Neuropsychol. 1995 Aug;17(4):529-35. doi: 10.1080/01688639508405143.

  PMID: 7593473 BACKGROUND

• Mikels JA, Fredrickson BL, Larkin GR, Lindberg CM, Maglio SJ, Reuter-Lorenz PA. Emotional category data on images from the International Affective Picture System. Behav Res Methods. 2005 Nov;37(4):626-30. doi: 10.3758/bf03192732.

  PMID: 16629294 BACKGROUND

• Wei M, Roodenrys S, Miller L, Barkus E. Complex Scenes From the International Affective Picture System (IAPS). Exp Psychol. 2020 May;67(3):194-201. doi: 10.1027/1618-3169/a000488.

  PMID: 32900297 BACKGROUND

• Constantinescu AC, Wolters M, Moore A, MacPherson SE. A cluster-based approach to selecting representative stimuli from the International Affective Picture System (IAPS) database. Behav Res Methods. 2017 Jun;49(3):896-912. doi: 10.3758/s13428-016-0750-0.

  PMID: 27287449 BACKGROUND

• Armario P, del Rey RH, Martin-Baranera M, Almendros MC, Ceresuela LM, Pardell H. Blood pressure reactivity to mental stress task as a determinant of sustained hypertension after 5 years of follow-up. J Hum Hypertens. 2003 Mar;17(3):181-6. doi: 10.1038/sj.jhh.1001530.

  PMID: 12624608 BACKGROUND

• Henze GI, Zankert S, Urschler DF, Hiltl TJ, Kudielka BM, Pruessner JC, Wust S. Testing the ecological validity of the Trier Social Stress Test: Association with real-life exam stress. Psychoneuroendocrinology. 2017 Jan;75:52-55. doi: 10.1016/j.psyneuen.2016.10.002. Epub 2016 Oct 17.

  PMID: 27771565 BACKGROUND

• Naliboff BD, Benton D, Solomon GF, Morley JE, Fahey JL, Bloom ET, Makinodan T, Gilmore SL. Immunological changes in young and old adults during brief laboratory stress. Psychosom Med. 1991 Mar-Apr;53(2):121-32. doi: 10.1097/00006842-199103000-00002.

  PMID: 2031066 BACKGROUND

• Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.

  PMID: 22178086 BACKGROUND

• Ahluwalia N, Dwyer J, Terry A, Moshfegh A, Johnson C. Update on NHANES Dietary Data: Focus on Collection, Release, Analytical Considerations, and Uses to Inform Public Policy. Adv Nutr. 2016 Jan 15;7(1):121-34. doi: 10.3945/an.115.009258. Print 2016 Jan.

  PMID: 26773020 BACKGROUND

• Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.

  PMID: 15333231 BACKGROUND

• Azpiroz F, Guyonnet D, Donazzolo Y, Gendre D, Tanguy J, Guarner F. Digestive Symptoms in Healthy People and Subjects With Irritable Bowel Syndrome: Validation of Symptom Frequency Questionnaire. J Clin Gastroenterol. 2015 Aug;49(7):e64-70. doi: 10.1097/MCG.0000000000000178.

  PMID: 25014236 BACKGROUND

• Guyonnet D, Schlumberger A, Mhamdi L, Jakob S, Chassany O. Fermented milk containing Bifidobacterium lactis DN-173 010 improves gastrointestinal well-being and digestive symptoms in women reporting minor digestive symptoms: a randomised, double-blind, parallel, controlled study. Br J Nutr. 2009 Dec;102(11):1654-62. doi: 10.1017/S0007114509990882. Epub 2009 Jul 22.

  PMID: 19622191 BACKGROUND

• Marteau P, Guyonnet D, Lafaye de Micheaux P, Gelu S. A randomized, double-blind, controlled study and pooled analysis of two identical trials of fermented milk containing probiotic Bifidobacterium lactis CNCM I-2494 in healthy women reporting minor digestive symptoms. Neurogastroenterol Motil. 2013 Apr;25(4):331-e252. doi: 10.1111/nmo.12078. Epub 2013 Mar 11.

  PMID: 23480238 BACKGROUND

• Rosas HD, Doros G, Bhasin S, Thomas B, Gevorkian S, Malarick K, Matson W, Hersch SM. A systems-level "misunderstanding": the plasma metabolome in Huntington's disease. Ann Clin Transl Neurol. 2015 Jul;2(7):756-68. doi: 10.1002/acn3.214. Epub 2015 May 28.

  PMID: 26273688 BACKGROUND

• Boyle SH, Matson WR, Velazquez EJ, Samad Z, Williams RB Jr, Sharma S, Thomas B, Wilson JL, O'Connor C, Jiang W. Metabolomics analysis reveals insights into biochemical mechanisms of mental stress-induced left ventricular dysfunction. Metabolomics. 2015 Jun 1;11(3):571-582. doi: 10.1007/s11306-014-0718-y.

  PMID: 25983674 BACKGROUND

• Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.

  BACKGROUND

• 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/.

  BACKGROUND

• 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.

  BACKGROUND

• Addolorato G, Ancona C, Capristo E, Graziosetto R, Di Rienzo L, Maurizi M, Gasbarrini G. State and trait anxiety in women affected by allergic and vasomotor rhinitis. J Psychosom Res. 1999 Mar;46(3):283-9. doi: 10.1016/s0022-3999(98)00109-3.

  PMID: 10193919 BACKGROUND

• Knight RG, Waal-Manning HJ, Spears GF. Some norms and reliability data for the State--Trait Anxiety Inventory and the Zung Self-Rating Depression scale. Br J Clin Psychol. 1983 Nov;22 (Pt 4):245-9. doi: 10.1111/j.2044-8260.1983.tb00610.x.

  PMID: 6640176 BACKGROUND

• DHQ W-b. Diet History Questionnaire II & Canadian Diet History Questionnaire II: Web-based DHQ. 2021. Available from: https://epi.grants.cancer.gov/dhq2/.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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/.

  BACKGROUND

• Spielberger CD, Gorsuch RL, Lushene R, Vag PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. 1983.

  BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Interventions

Phytoalexins

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Toxins, Biological; Biological Factors

Study Officials

• Arpana Gupta, PhD

  The Regents of the University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 30, 2021
• Study Start: June 25, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)