NCT05525845
Recruiting
Not Applicable
Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans
ConditionsHealthy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Mayo Clinic
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Difference in Cerebral Blood Flow related to hypothalamus
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.
Investigators
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •BMI 18-25 kg/m\^
- •Weight stable for 3 months prior to study entry.
- •For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
- •Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures..
- •Ability to perform light to moderate physical activity.
Exclusion Criteria
- •Any contraindication for MRI scanning.
- •Any history of childhood (\> 95th percentile) or adult obesity (BMI \>30 kg/m\^2).
- •Claustrophobia.
- •High intensity training or physical activity.
- •Any contraindication for intragastric balloon insertion.
- •Any allergies to the study meals.
- •Any history of eating disorder.
- •Any substance abuse disorder (including alcohol and tobacco).
- •Any history of psychiatric disorders.
- •Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
Outcomes
Primary Outcomes
Difference in Cerebral Blood Flow related to hypothalamus
Time Frame: 1 month
The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.
Secondary Outcomes
- Cerebral Bloodflow related in multiple brain areas(1 month)
- Cerebral Blood Flow between three stimuli(1 month)
- Time differences in stimuli(1 month)
- Caloric consumption differences in stimuli(1 month)
- comparison of calories(1 month)
- hormone level comparison(1 month)
- Hormone level(1 month)
- calorie corellation to hormones(1 month)
- FitBit measured Physical Activity(1 month)
Study Sites (1)
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