NCT06800794Active, not recruiting
Investigating Metabolic and Psychological Adaptations in a Clinical Trial
Effect of Meal Timing and Dietary Changes on Metabolic and Behavioral Factors Involved in the Food Insecurity-Obesity Paradox
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 17 Jan 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- State University of New York at Buffalo
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06800794
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 16 Jul 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Food allergies to study-related foods, including dairy, soy, nuts, or gluten.
- History of bariatric surgery or GLP-1 agonist use (self-report).
Lab values
- Uncontrolled diabetes (HbA1c \> 9%) or hypertension (blood pressure \> 160/100 mmHg), based on self-report or screening visit measurements.
Other
- 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).
- Recent weight loss exceeding 5% of body weight within the past 6 months (self-report).
- Inability to read or write in English (self-report).
- Planned relocation out of the study area during the study timeframe (self-report).
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Farber Hall G56 Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.