Cortisol and Food Insecurity

NCT ID: NCT05191030

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2025-09-23

Brief Summary

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.

Conditions

Food Insecurity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High-Stress Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High-Stress Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

A. Janet Tomiyama

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A. Janet Tomiyama, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8255414 (View on PubMed)

American Diabetes Association. Diabetes care standards of medical care in Diabetes - 2019. J Clin Appl Res Educ 2019.

Reference Type: BACKGROUND

Other Identifiers

R01DK128575

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-000048

Identifier Type: -

Identifier Source: org_study_id