The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Oxytocin.

Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability in older adults.

It had two arms (groups): Oxytocin nasal spray (experimental) and Placebo nasal spray (experimental).

Placebo nasal spray, 4x a day for 8 weeks, self administered.

The registry classes the interventions as drug.

More on the Plan

The pilot study will be conducted at 3 sites in 9 visits over a period of 12+ weeks.

Older sedentary subjects will be screened for sarcopenic obesity using a modified consensus definition and evaluated at baseline for safety labs, glucose tolerance, body composition, cognition and physical performance, as well as systemic inflammatory markers in blood and muscle tissue.

Generalized linear mixed effects model will be used to evaluate the effect of oxytocin on the change of each continuous measure.

Who Took Part

Enrollment: 23 actual participants took part.

It was open to people of any sex aged from 60 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI 30-40 kg/m2. Sedentary (\< 2 strenuous exercise/week). Gait speed \< 1 meter/second.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: diabetes (ada criteria); heart disease (mi or new york heart classification grade iii-iv); poorly controlled hypertension (sbp \> 170 or dbp \>95 mm/hg).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-09-22 with completion listed for 2018-12-17.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in Body Weight (time frame: Baseline to 8 weeks).

It also tracked 12 secondary outcomes, for example Change in Fat Mass, Change in Body Mass Index, Change in Glucose Levels Measured Using the Glucose Tolerance Test, Change in Short Physical Performance Battery (SPPB), Change in HbA1c (Hemoglobin A1c) and Change in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.