Cortisol and Food Insecurity

Food Insecurity Clinical Trial

Official title:

Food Insecurity, Poor Diet, and Metabolic Syndrome: Cortisol's Amplifying Role

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191030
• Other study ID #: 21-000048
• Secondary ID: R01DK128575
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: Alejandra Lopez, B.A.
• Phone: 310-825-9092
• Email: alopez[@]psych.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity

Intervention

Behavioral:
• High-Stress Intervention
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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.