- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05191030
Cortisol and Food Insecurity
September 23, 2025 updated by: A. Janet Tomiyama, University of California, Los Angeles
Food Insecurity, Poor Diet, and Metabolic Syndrome: Cortisol's Amplifying Role
This study will use a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 50% men).
These participants will then, in counterbalanced order, be exposed to a gold-standard laboratory stressor and a control condition, one month apart.
Moderation analyses will test whether cortisol reactivity to the stressor acts as a modulator of the relationship between high levels of food insecurity and increased hyperpalatable food intake.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
453
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18+
- English-speaking
Exclusion Criteria:
- Recent (<1 year) diagnosis of major psychiatric disorders including any mood disorder, schizophrenia, or PTSD
- Recent (<1 year) diagnosis of eating disorder
- Recent (<1 year) diagnosis of metabolic or endocrine disorder or steroid or hormonal contraceptive use
- Pregnancy
- Allergy to any of the foods in the food buffet
- Participation in strict dieting or caloric restriction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental (High-Stress) Arm
Participants undergoing the experimental (high-stress) arm are exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993).
Participants are given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant).
The speech task posits the participant in a mock interview, with the two panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions.
Participants undergoing the mental arithmetic task are instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible.
If the participant makes a mistake, the panelist interrupts them and instructs them to start the task again from the beginning.
The panelists also constantly remind the participant to "go faster" if they start to slow down with the task.
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Those undergoing the High-Stress will be exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993), which reliably induces cortisol reactivity in most individuals.
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No Intervention: Control Arm
Participants undergoing the control arm are presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) arm.
For the speech task, participants are instructed to talk out loud to themselves for five minutes about a movie or book of their choice.
Their speech is recorded using a small audio recorder device the research assistant prepares.
For the mental arithmetic task, participants are instructed to count by increments of 15 starting from zero to the largest number they can reach.
Participants are left in the room alone for the task for five minutes, after which the participant self-reports to the research assistant the number they reached.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hyperpalatable Food Intake Measured in Kilocalories
Time Frame: Hyperpalatable food intake will be measured immediately after the intervention.
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The primary outcome will be hyperpalatable food intake, initially measured in grams and converted into kilocalories.
The food will consist of the following items: donuts, M&Ms, potato chips, crackers, and Sprite.
These foods were chosen because processed foods, added sugars, refined grains, starchy vegetables, and sugar sweetened beverages are foods to avoid according to the 2019 American Diabetes Association Nutrition Consensus Report and are high in carbohydrates and glycemic index.
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Hyperpalatable food intake will be measured immediately after the intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: A. Janet Tomiyama, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
- American Diabetes Association. Diabetes care standards of medical care in Diabetes - 2019. J Clin Appl Res Educ 2019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2022
Primary Completion (Actual)
September 23, 2025
Study Completion (Actual)
September 23, 2025
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
January 12, 2022
First Posted (Actual)
January 13, 2022
Study Record Updates
Last Update Posted (Estimated)
September 29, 2025
Last Update Submitted That Met QC Criteria
September 23, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-000048
- R01DK128575 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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