Cortisol and Food Insecurity

NCT05191030 | Completed

• 2 other identifiers: 21-000048R01DK128575
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 1

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

Keywords

Food insecurity; Physiological Stress; Psychological Stress; Cortisol; Eating; Diet

Outcome Measures

Primary Outcomes (1)

• Hyperpalatable Food Intake Measured in Kilocalories

  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.

  Hyperpalatable food intake will be measured immediately after the intervention.

Study Arms (2)

Experimental (High-Stress) Arm

EXPERIMENTAL

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.

Behavioral: High-Stress Intervention

Control Arm

NO INTERVENTION

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.

Interventions

High-Stress Intervention 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.

Experimental (High-Stress) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• English-speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 8255414 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• A. Janet Tomiyama, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study is a within-subjects experiment. The order in which participants undergo the experimental or control conditions/arms will be counterbalanced. 50% of participants will undergo the experimental condition first and then the control condition, one month later. The rest of the sample will undergo the control condition first then the experimental condition, one month later.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 13, 2022
• Study Start: March 11, 2022
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)