Trial Outcomes & Findings for Cortisol and Food Insecurity (NCT NCT05191030)

NCT ID: NCT05191030

Last Updated: 2026-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

453 participants

Primary outcome timeframe

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.

Results posted on

2026-07-10

Participant Flow

Participant milestones

Participant milestones
Measure
Experimental (High Stress) First, Then Control
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. 4 weeks later, participants completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached.
Control First, Then Experimental (High Stress)
Participants first completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached. 4 weeks later, participants 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.
Overall Study
STARTED
231
222
Overall Study
COMPLETED
200
200
Overall Study
NOT COMPLETED
31
22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cortisol and Food Insecurity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental (High Stress) First, Then Control
n=200 Participants
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. 4 weeks later, participants completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached.
Control First, Then Experimental (High Stress)
n=200 Participants
Participants first completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached. 4 weeks later, participants 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.
Total
n=400 Participants
Total of all reporting groups
Age, Continuous
35.28 Years
STANDARD_DEVIATION 14.362 • n=9 Participants
33.74 Years
STANDARD_DEVIATION 13.143 • n=27 Participants
34.52 Years
STANDARD_DEVIATION 13.776 • n=267 Participants
Sex/Gender, Customized
Men
87 Participants
n=9 Participants
91 Participants
n=27 Participants
178 Participants
n=267 Participants
Sex/Gender, Customized
Women
102 Participants
n=9 Participants
100 Participants
n=27 Participants
202 Participants
n=267 Participants
Sex/Gender, Customized
Non-Binary/Other
11 Participants
n=9 Participants
8 Participants
n=27 Participants
19 Participants
n=267 Participants
Race/Ethnicity, Customized
Hispanic or Latino/a/x
51 Participants
n=9 Participants
58 Participants
n=27 Participants
109 Participants
n=267 Participants
Race/Ethnicity, Customized
Asian
44 Participants
n=9 Participants
49 Participants
n=27 Participants
93 Participants
n=267 Participants
Race/Ethnicity, Customized
Black or African American
28 Participants
n=9 Participants
23 Participants
n=27 Participants
51 Participants
n=267 Participants
Race/Ethnicity, Customized
More than One Race
14 Participants
n=9 Participants
10 Participants
n=27 Participants
24 Participants
n=267 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=9 Participants
5 Participants
n=27 Participants
7 Participants
n=267 Participants
Race/Ethnicity, Customized
White
61 Participants
n=9 Participants
54 Participants
n=27 Participants
115 Participants
n=267 Participants

PRIMARY outcome

Timeframe: 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.

Population: One participant was removed from analysis due to staff entry error leading to ambiguity regarding condition assignment.

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.

Outcome measures

Outcome measures
Measure
Experimental (High Stress)
n=399 Participants
Participants who underwent the experimental (high-stress) arm 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 posited 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 who underwent the mental arithmetic task 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 also constantly reminded the participant to "go faster" if they started to slow down with the task.
Control
n=399 Participants
Participants who underwent the control arm were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) arm. 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.
Hyperpalatable Food Intake Measured in Kilocalories
369.069 Kilocalories
Standard Deviation 274.538
394.822 Kilocalories
Standard Deviation 245.856

Adverse Events

Experimental (High Stress)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

A. Janet Tomiyama

University of California, Los Angeles

Phone: 310-206-6875

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place