Oxytocin Effects on Food Motivation Pathways

NCT02276677 | Completed Early Phase 1

• 1 other identifier: SPID 1127
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the mechanisms for this effect in humans is not yet clear. In this study, the investigators will therefore examine the effect of a single dose of intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and functional magnetic resonance imaging activation of areas of the brain involved in food motivation.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in functional magnetic resonance imaging activation of food motivation brain regions

  Functional magnetic resonance imaging at T60 min after oxytocin/placebo

Secondary Outcomes (1)

• Change in hormone levels (cholecystokinin, glucagon-like peptide-1)

  Blood draws at T0, T30, T60, T120 min after oxytocin/placebo

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin 24 IU x 1

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo 24 IU x 1

Drug: Placebo

Interventions

Oxytocin DRUG

Single dose, intranasal

Also known as: Syntocinon

Oxytocin

Placebo DRUG

Single dose, intranasal

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years old
• BMI 25-40
• Regular breakfast eater (at least 4 times per week)
• Stable weight within the past three months

You may not qualify if:

• Psychiatric disease, use of psychotropic medications
• History of eating disorder
• History of excessive exercise within the last three months (having run more that 25 miles in any one week or having exercised more than ten hours in any one week)
• History of diabetes mellitus
• Active substance abuse
• Hematocrit lower than the normal range
• Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
• History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
• Untreated thyroid disease
• Tobacco use
• Cardiac pacemaker, surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in body/eyes, nitroglycerin patch, severe claustrophobia

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elizabeth A Lawson, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

US (1)