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

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

    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

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.
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.
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.

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.
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.

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.

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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