The Effects of Oxytocin in Obese Adults

Overview

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 20, 2022

Interventions

  • Drug: oxytocin nasal spray
    • oxytocin intranasal spray
  • Drug: Placebo
    • Placebo nasal spray

Arms, Groups and Cohorts

  • Experimental: oxytocin
    • oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
  • Placebo Comparator: placebo
    • placebo nasal spray (4 times per day for 8 weeks)

Clinical Trial Outcome Measures

Primary Measures

  • Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
    • Time Frame: Baseline to 8 weeks
    • The mean difference in weight loss between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline, Week 2, Week 4, Week 6, and Week 8) and Group (oxytocin/placebo) and the interaction Time*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.

Secondary Measures

  • Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo
    • Time Frame: Baseline to 8 weeks
    • The mean difference in resting energy expenditure between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time*Group controlled for sex (male/female), obesity class (class I, II, and III), and lean mass to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group. Reported are model estimates rounded to one decimal.
  • Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo
    • Time Frame: Baseline to 8 weeks
    • The mean difference in total fat mass between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
  • Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo
    • Time Frame: Baseline to 6 weeks
    • The mean difference in caloric intake between oxytocin- and placebo-treated groups from baseline to 6 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 6) and Group (oxytocin/placebo) and the interaction Time*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.

Participating in This Clinical Trial

Inclusion Criteria

  • 18-45 years old; – BMI greater than or equal to 30 kg/m2 Exclusion Criteria:

  • Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months); – history of medication changes within 4 weeks of enrollment; – active substance use; – history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease; – hematocrit >2% below normal; – fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ; – ALT or AST >2.5 times upper limit of normal; – Cr >1.5 mg/dL; hyponatremia; – pregnancy or breastfeeding; – unwilling to use medically acceptable form of contraception (females only) – follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet) – current smoking or tobacco use

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elizabeth Austen Lawson, Associate Professor of Medicine, Harvard Medical School – Massachusetts General Hospital
  • Overall Official(s)
    • Elizabeth A Lawson, MD, Principal Investigator, Massachusetts General Hospital

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