Cortisol and Food Insecurity

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Food Insecurity

Treatments: Behavioral: High-Stress Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05191030

21-000048

R01DK128575 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 453 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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453 participants in 2 patient groups

Experimental (High-Stress) Arm

Experimental group

Description:

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.

Treatment:

Behavioral: High-Stress Intervention

Control Arm

No Intervention group

Description:

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.