Investigating Metabolic and Psychological Adaptations in a Clinical Trial
Running, not enrolling · Not applicable
Conditions studied: Obesity and Type 2 Diabetes
In brief
This study aims to explore how food insecurity, a lack of consistent access to enough food, may lead to changes in the body that make it harder to lose weight. The investigators are testing whether providing women experiencing food insecurity with a stable, healthy, and personalized meal plan can improve their metabolism and reduce their motivation to eat unhealthy foods. The hypothesis is that addressing food insecurity with a predictable diet can lower a person's respiratory quotient (a measure of how the body uses energy), promote fat burning, and improve overall health. This research will improve the understanding for how food insecurity contributes to obesity and may lead to better solutions for managing weight in individuals facing these challenges.
Key facts
- Study ID
- NCT06800794
- Run by
- State University of New York at Buffalo
- People needed
- 12
- Starts
- 2025-07-16
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Woman between the ages of 18-45.
- Premenopausal.
- Obese (BMI ≥ 30).
- Diagnosed with prediabetes (HbA1c: 5.7%-6.4%).
- Experiencing food insecurity (score of 2-6 on the six-item food insecurity questionnaire).
- Income below 300% of the household federal poverty threshold.
- Lives alone.
You may not qualify if…
- Actively planning to become pregnant (e.g., individuals trying to conceive or undergoing fertility treatment, based on self-report).
- Delivered a baby within the past 6 months (self-report).
- Non-ambulatory (e.g., individuals unable to walk independently or requiring a wheelchair for mobility).
- Intellectual impairment that would impact treatment adherence.
- Unmanaged mood disorders, substance use disorders, personality disorders, or a history of eating disorders, including:
- Generalized anxiety disorder.
- Depression.
- Alcohol dependence.
- Schizophrenia.
- Anorexia nervosa, bulimia, or binge eating disorder within the past 6 months.
- Recent weight loss exceeding 5% of body weight within the past 6 months (self-report).
- Food allergies to study-related foods, including dairy, soy, nuts, or gluten.
- History of bariatric surgery or GLP-1 agonist use (self-report).
- Inability to read or write in English (self-report).
- Planned relocation out of the study area during the study timeframe (self-report).
- Uncontrolled diabetes (HbA1c > 9%) or hypertension (blood pressure > 160/100 mmHg), based on self-report or screening visit measurements.
Where it is running
- Farber Hall G56 — Buffalo, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.