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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

Short name INOSO

NCTNCT03119610 (opens ClinicalTrials.gov in a new tab)Other idHSC20160661H
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
23 participants (actual)
Sponsor
Sara Espinoza · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
22 Sept 2017
Primary completion
17 Dec 2018
Completion
17 Dec 2019
First posted
18 Apr 2017
Last update posted
22 Oct 2021
Conditions
Obesity · Sarcopenic Obesity · Sarcopenia · Aging · Sedentary Lifestyle

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 1/2

    INOSO

    NCT03119610

    22 Sept 2017 to 17 Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many have difficulty adhering to an exercise program and the benefits of exercise are variable. Therefore, there is an urgent need to test novel pharmacologic interventions to prevent disability and loss of independence. Oxytocin is a pituitary hormone released during parturition and lactation that is also known to suppress appetite in rodents and humans; and, recent small studies have found that intranasal oxytocin reduces body weight in adults. We propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and increase muscle mass in older subjects with sarcopenic obesity.

Interventions

  • Oxytocin nasal sprayDrug
  • Placebo nasal sprayDrug

Arms2

  • Experimental

    Oxytocin nasal spray

    Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered

  • Experimental

    Placebo nasal spray

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Weight

    Time frame · Baseline to 8 weeks

    Registry description

    Intranasal oxytocin will promote weight loss and preserve muscle mass

Secondary outcomes(12)

  1. Change in Fat Mass

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements of fat mass by dual energy x-ray absorptiometry (DXA) will be examined for individual change with intranasal oxytocin

  2. Change in Body Mass Index

    Time frame · 8 weeks

    Registry description

    Pre- and post-measurements of lean mass by DXA will be examined for individual change with intranasal oxytocin. Change in body mass index (BMI).

  3. Change in Glucose Levels Measured Using the Glucose Tolerance Test

    Time frame · 8 weeks

    Registry description

    Pre- and post-measurements of oral glucose tolerance test for 2-hour plasma glucose will be examined for individual change with intranasal oxytocin

  4. Change in Short Physical Performance Battery (SPPB)

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin. This battery of tests is scored on a scale with 3 SPPB calculation components: 1. Ability to stand for 10 seconds with feet in 3 different positions, scored from 0 min to 4 maximum, with a higher score indicating better balance.(3 Balance subsets: side by side stand scored from 0-1; semi-tandem stance scored from 0-1; tandem stance scored from 0-2) 2. Two timed trials of a 3m or 4 m walk (fastest recorded). Scoring is from 0-4, with 0 being unable to walk and 4 indicating a faster walk time. 3. Time to rise from a chair five times is scored from 0-4, with 0 being unable to complete the activity, and 4 indicating that time to complete is less than 11.1 seconds. Total Score is the sum of all 3 scores: Minimum = 0 Maximum = 12. Higher scores indicate better lower extremity function. Difference between baseline and 8 week performance is reported.

  5. Change in HbA1c (Hemoglobin A1c)

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  6. Change in Waist Circumference

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  7. Change in Total Cholesterol

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  8. Change in Low Density Lipoproteins (LDL)

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  9. Change in High Density Lipoproteins (HDL)

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  10. Change in Triglycerides

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  11. Change in Center for Epidemiologic Studies Scale (CES-D)

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin. This is measured on a 20 item scale using the following scoring using number of week days: 1. Rarely or none of the time ( less than 1 day) 2. Some or a little of the time (1-2 days) 3. Occasionally or a moderate amount of time (3-4 days) 4. Most or all of the time (5-7 days) SCORING: zero for answers =1), 1 for answers =2), 2 for answers =3) column, 3 for answers =4) The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

  12. Change in Montreal Cognitive Assessment (MoCA)

    Time frame · Baseline to 8 weeks

    Registry description

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin. A 30-point test, with a score of 0 or 1 assigned to each item. The minimum score is 0 and the maximum is 30. The higher the score, the less cognitive impairment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline to 8 weeks

Change in Body Weight

GroupValue (Kilograms)Spread
Oxytocin Nasal Spray0.541.6
Placebo Nasal Spray0.042.5
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline to 8 weeks

Change in Fat Mass

GroupValue (Kilograms)Spread
Oxytocin Nasal Spray-0.20.99
Placebo Nasal Spray-0.10.92
Secondary outcomeMean· 8 weeks

Change in Body Mass Index

GroupValue (kg/m2)Spread
Oxytocin Nasal Spray36.83.5
Placebo Nasal Spray36.83.6
Secondary outcomeMean· 8 weeks

Change in Glucose Levels Measured Using the Glucose Tolerance Test

GroupValue (mg/dL)Spread
Oxytocin Nasal Spray3.3610.18
Placebo Nasal Spray2.856.28
Secondary outcomeMean· Baseline to 8 weeks

Change in Short Physical Performance Battery (SPPB)

GroupValue (score on a scale)Spread
Oxytocin Nasal Spray0.51.446
Placebo Nasal Spray0.6251.598
Secondary outcomeMean· Baseline to 8 weeks

Change in HbA1c (Hemoglobin A1c)

GroupValue (Percentage)Spread
Oxytocin Nasal Spray-0.050.1857
Placebo Nasal Spray0.2860.1254
Secondary outcomeMean· Baseline to 8 weeks

Change in Waist Circumference

GroupValue (centimeteres)Spread
Oxytocin Nasal Spray-0.69584.8662
Placebo Nasal Spray-1.3732.1997
Secondary outcomeMean· Baseline to 8 weeks

Change in Total Cholesterol

GroupValue (mg/dL)Spread
Oxytocin Nasal Spray-11.1817.417
Placebo Nasal Spray-1.14316.056

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin Nasal SprayOxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)0 / 120 / 1212 / 12
Placebo Nasal SprayPlacebo nasal spray, 4x a day for 8 weeks, self administered Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)0 / 90 / 99 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

10 results

Intranasal Oxytocin Improves Lean Muscle Mass and Lowers LDL Cholesterol in Older Adults with Sarcopenic Obesity: A Pilot Randomized Controlled Trial.

Espinoza et al. 2021Journal of the American Medical Directors Associationcited by 35

PMID 34029521PMC8567747DOI 10.1016/j.jamda.2021.04.015PUB-34029521

Rights unknown10 results
Source linkSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 60 Years up to 99 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * BMI 30-40 kg/m2 * Sedentary (\< 2 strenuous exercise/week) * Gait speed \< 1 meter/second Exclusion Criteria: * Diabetes (ADA criteria) * Heart disease (MI or New York Heart Classification grade III-IV) * Poorly controlled hypertension (SBP \> 170 or DBP \>95 mm/Hg) * Anemia (Hematocrit \<34%) * Renal Disease (Serum Creatinine \>1.4, abnormal serum sodium levels, abnormal urinalysis, or physical exam findings indicative of fluid imbalance; individuals with underlying disorder of sodium/water balance, such as SIADH, diabetes insipidus, or psychogenic polydipsia) * Liver Disease (AST/ALT/AlkPhos \> 2x upper limit of normal) * Use of systemic steroid, androgens, or anti-coagulants * Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders * Individuals with underlying seizure disorder or underlying neurologic disorder that increases seizure risk * Cognitive impairment (MiniCog \<3), unstable mental illness, substance abuse, or history of eating disorder

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