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Oxytocin Aging Study

NCT02069431 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2020-06-19

No results posted yet for this study

Summary

The life expectancy of older Americans continues to increase, with persons aged \> 65 years representing the fastest growing segment of the US population (Manton et al., 1995). While prolongation of life remains an important public health goal, a goal of even greater significance is that extended life should involve preservation of the capacity to live independently and to function well physically, cognitively, and socioemotionally (Katz et al., 1983). Therefore, identification of proven interventions to maintaining functioning across these domains and prevent disability is a major public health challenge (Branch et al., 1991). Greater physical and cognitive independence in older adults has been shown to crucially influence social integration in old age (Cornwell \& Waite, 2009), resulting in significant increase in quality of life and reduction of risk for morbidity and mortality, social stress, anxiety, and depressive symptoms (Bassuk et al., 1999; Seeman, 1996). A promising candidate to promote functional levels across physical, cognitive, and socioemotional domains is the neuropeptide oxytocin (OT) (Barraza et al., 2013; Bartz et al., 2011; Feifel et al., 2012; Meyer-Lindenberg et al., 2011; Szeto et al., 2012). Combining neuroendocrine with behavioral approaches (e.g., performance-based measures of physical and cognitive function), the proposed multidisciplinary research therefore sets out to clarify the extent to which intranasal administration of OT over a period of 4 weeks can reduce inflammation and improve physical and cognitive function in older men. Constituting a complementary piece to the IRB approved currently ongoing Faces Study (IRB # 39-2013), this project will also allow examination of interactions between OT's effect on physical health, cognition, and socioemotional function.

Conditions

Interventions

DRUG

Intranasal Oxytocin spray

Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.

OTHER

Intranasal Placebo spray

placebo (containing all of the inert ingredients except for the oxytocin) self-administration will take place twice a day over a 28-day period.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Natlie Ebner, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-05-31
Completion
2020-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069431 on ClinicalTrials.gov