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Clinical Trials/NCT05525845
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

Mayo Clinic1 site in 1 country15 target enrollmentSeptember 8, 2022
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.

Registry
clinicaltrials.gov
Start Date
September 8, 2022
End Date
August 1, 2028
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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