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.
COMPLETED
NA
453 participants
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.
2026-07-10
Participant Flow
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
| 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
| 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.
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|---|---|---|
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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)
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place