Targeting the Gut-brain Axis to Facilitate Weight Loss in High Fat Diet Consumers

• Status: Recruiting
• Trial end date: 2026-02-26
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to test if fat intake moderates the ability of Oleoylthanolamide (OEA) to improve weight loss maintenance after the LEARN® weight loss program.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

• Ages 18-45

• Right-handed with a score of ≥ +50 on the modified Edinburgh handedness scale

• English-speaking

• BMI > 25.0

• Comfortable with the fMRI procedures during the mock scanning session and rate milkshake as at least mildly liked

Exclusion Criteria:

• Serious or unstable medical illness (e.g., cancer)

• Past or current history of alcoholism or consistent drug use

• Current major psychiatric illness as defined by DSM-IV criteria including eating disorders

• Medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)

• History of major head trauma with loss of consciousness

• Ongoing pregnancy

• History of metalworking, injury with shrapnel or metal slivers, or major surgery

• History of pacemaker or neurostimulator implantation

• Known taste or smell dysfunction

• A diagnosis of diabetes

• Any known food allergy