Food InsecurityNCT05191030
Cortisol and Food Insecurity
A study testing High-Stress Intervention in people with Food Insecurity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study used a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 44.5% men). These participants then, in counterbalanced order, were exposed to a gold-standard laboratory stressor and a control condition, one month apart. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- High-Stress Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- English-speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Food Insecurity, Poor Diet, and Metabolic Syndrome: Cortisol's Amplifying Role
This study used a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 44.5% men). These participants then, in counterbalanced order, were 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.
- Conditions
- Food Insecurity
- Being tested
- High-Stress Intervention
- Keywords
- Food insecurity, Physiological Stress, Psychological Stress, Cortisol, Eating, Diet
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Stress InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (High Stress) First, Then Control | Experimental | Participants first completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were 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 put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. Receives: Behavioral: High-Stress Intervention |
| Control First, Then Experimental (High Stress) | No intervention | Participants first underwent the control condition during which they were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) condition. For the speech task, participants were instructed to talk out loud to themselves for five minutes about a movie or book of their choice. Their speech was recorded using a small audio recorder device the research assistant prepared. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from zero to the largest number they could reach. Participants were left in the room alone for the task for five minutes, after which the participant self-reported to the research assistant the number they reached. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperpalatable Food Intake Measured in Kilocalories
The primary outcome was hyperpalatable food intake, initially measured in grams and converted into kilocalories. The food consisted 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.
Measured: Hyperpalatable food intake was measured twice: 5 minutes following the experimental (high stress) or control condition during the first visit, and again 5 minutes following the alternate condition during the second visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start11 Mar 2022
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a within-subjects experiment. The order in which participants underwent the experimental or control conditions/arms was counterbalanced. 50% of participants underwent the experimental condition first and then the control condition, one month later. The rest of the sample underwent the control condition first then the experimental condition, one month later.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Janet Tomiyama, University of California, Los Angeles
- Investigators
- A. Janet Tomiyama, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191030
- Sponsor's protocol ID
- 21-000048
- Other IDs
- R01DK128575
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2022
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 8255414American Diabetes Association. Diabetes care standards of medical care in Diabetes - 2019. J Clin Appl Res Educ 2019.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity, Poor Diet, and Metabolic Syndrome: Cortisol's Amplifying Role
- ClinicalTrials.gov ID
- NCT05191030
- Acronym / sponsor ID
- 21-000048
- Conditions
- Food Insecurity
- Keywords
- Food insecurity, Physiological Stress, Psychological Stress, Cortisol, Eating, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study used a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 44.5% men). These participants then, in counterbalanced order, were 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a within-subjects experiment. The order in which participants underwent the experimental or control conditions/arms was counterbalanced. 50% of participants underwent the experimental condition first and then the control condition, one month later. The rest of the sample underwent the control condition first then the experimental condition, one month later.
| Arm | Type | Receives |
|---|---|---|
| Experimental (High Stress) First, Then Control | Experimental | Behavioral: High-Stress InterventionParticipants first completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were 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 put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. |
| Control First, Then Experimental (High Stress) | No intervention | –Participants first underwent the control condition during which they were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) condition. For the speech task, participants were instructed to talk out loud to themselves for five minutes about a movie or book of their choice. Their speech was recorded using a small audio recorder device the research assistant prepared. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from zero to the largest number they could reach. Participants were left in the room alone for the task for five minutes, after which the participant self-reported to the research assistant the number they reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18+
- English-speaking
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Stress InterventionThose 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. | Behavioural | Experimental (High Stress) First, Then Control |
Primary outcome
Hyperpalatable Food Intake Measured in Kilocalories
Time frame: Hyperpalatable food intake was measured twice: 5 minutes following the experimental (high stress) or control condition during the first visit, and again 5 minutes following the alternate condition during the second visit.
The primary outcome was hyperpalatable food intake, initially measured in grams and converted into kilocalories. The food consisted 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8255414Kirschbaum 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.
- BackgroundAmerican Diabetes Association. Diabetes care standards of medical care in Diabetes - 2019. J Clin Appl Res Educ 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Janet Tomiyama, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Stress Intervention in people with Food Insecurity, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperpalatable Food Intake Measured in Kilocalories (time frame: Hyperpalatable food intake was measured twice: 5 minutes following the experimental (high stress) or control condition during the first visit, and again 5 minutes following the alternate condition during the second visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191030, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.