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Oxytocin Aging Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069431
Recruitment Status : Terminated (This study was halted prematurely due to the COVID-19 pandemic, resulting in the inability to enroll participants. Funding for this project has also ended.)
First Posted : February 24, 2014
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammation Drug: Intranasal Oxytocin spray Other: Intranasal Placebo spray Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oxytocin on Physical and Cognitive Functioning in the Elders
Study Start Date : February 2016
Actual Primary Completion Date : May 2020
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Intranasal Oxytocin spray
Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.
Drug: Intranasal Oxytocin spray
Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. The use of intranasal oxytocin (OT) will reduce inflammatory biomarkers in older men and women after the 4 week treatment (post intervention). [ Time Frame: Day 28 ]
    The use of intranasal OT will reduce inflammatory biomarkers (IL-6, tumor necrosis factor (TNF)-α, TNF-sR1, TNF-sR2, CRP) measured in blood samples.


Secondary Outcome Measures :
  1. The use of intranasal OT will improve objective and subjective physical function (gait, balance, fatigue, etc.) in older men and women after the 4 week treatment (post intervention). [ Time Frame: Day 28 ]
  2. The use of intranasal OT will improve socioemotional function (face processing, emotion processing, etc.) in older men and women after the 4 week treatment (post intervention). [ Time Frame: Day 28 ]

Other Outcome Measures:
  1. The use of intranasal OT will improve auditory and cognitive function (executive functioning, attention, memory, etc.) in older men and women after the 4 week treatment (post intervention). [ Time Frame: Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • males and females aged 55 years or older
  • generally healthy physically and cognitively
  • blood pressure < 180/100 mm Hg
  • willing and able to give informed consent.

Exclusion Criteria:

  • participants will be extensively screened for study eligibility aligning with study and safety requirements related to drug application and Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069431


Locations
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United States, Florida
Clinical Research Center
Gainesville, Florida, United States, 32611
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Natlie Ebner, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02069431    
Other Study ID Numbers: IRB201300801-N
AG028740 ( Other Grant/Funding Number: Pepper Center )
P30AG028740 ( U.S. NIH Grant/Contract )
F016327 ( Other Grant/Funding Number: UF FOU )
AGR DTD 09-01-2016 ( Other Grant/Funding Number: Price-IOA-CTSI )
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
inflammation
physical function
cognitive function
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs