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The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity (INOSO)

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: NCT03119610
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center, Houston
The University of Texas Medical Branch, Galveston
Information provided by (Responsible Party):
Sara Espinoza, The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Obesity
Sarcopenic Obesity
Sarcopenia
Aging
Sedentary Lifestyle
Interventions Drug: Oxytocin nasal spray
Drug: Placebo nasal spray
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description

Oxytocin (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)

Placebo 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)

Period Title: Overall Study
Started 13 10
Completed 12 9
Not Completed 1 1
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             0             1
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray Total
Hide Arm/Group Description

Oxytocin (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)

Placebo 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)

Total of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Age, 60 or over Number Analyzed 13 participants 10 participants 23 participants
13
 100.0%
10
 100.0%
23
 100.0%
[1]
Measure Description: Participants are included if age 60 or over.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
8
  61.5%
8
  80.0%
16
  69.6%
Male
5
  38.5%
2
  20.0%
7
  30.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Hispanic or Latino
2
  15.4%
1
  10.0%
3
  13.0%
Not Hispanic or Latino
11
  84.6%
9
  90.0%
20
  87.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  15.4%
3
  30.0%
5
  21.7%
White
11
  84.6%
7
  70.0%
18
  78.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 10 participants 23 participants
13 10 23
1.Primary Outcome
Title Change in Body Weight
Hide Description Intranasal oxytocin will promote weight loss and preserve muscle mass
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants withdrew after randomization; 1 in Oxytocin and 1 in Placebo group. Data from these two subjects were not collected.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: Kilograms
0.54  (1.6) 0.04  (2.5)
2.Secondary Outcome
Title Change in Fat Mass
Hide Description Pre- and post-measurements of fat mass by dual energy x-ray absorptiometry (DXA) will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: Kilograms
-0.2  (0.99) -0.1  (0.92)
3.Secondary Outcome
Title Change in Body Mass Index
Hide 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).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: kg/m2
36.8  (3.5) 36.8  (3.6)
4.Secondary Outcome
Title Change in Glucose Levels Measured Using the Glucose Tolerance Test
Hide Description Pre- and post-measurements of oral glucose tolerance test for 2-hour plasma glucose will be examined for individual change with intranasal oxytocin
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
Fasting glucose 3.36  (10.18) 2.85  (6.28)
2-hour glucose -3.15  (31.126) -3.375  (14.88)
5.Secondary Outcome
Title Change in Short Physical Performance Battery (SPPB)
Hide 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.

Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.5  (1.446) 0.625  (1.598)
6.Secondary Outcome
Title Change in HbA1c (Hemoglobin A1c)
Hide Description Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: Percentage
-0.05  (0.1857) 0.286  (0.1254)
7.Secondary Outcome
Title Change in Waist Circumference
Hide Description Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: centimeteres
-0.6958  (4.8662) -1.373  (2.1997)
8.Secondary Outcome
Title Change in Total Cholesterol
Hide Description Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-11.18  (17.417) -1.143  (16.056)
9.Secondary Outcome
Title Change in Low Density Lipoproteins (LDL)
Hide Description Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-8.727  (16.224) 4.1429  (11.539)
10.Secondary Outcome
Title Change in High Density Lipoproteins (HDL)
Hide Description Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.000  (2.8983) 0.1429  (3.8408)
11.Secondary Outcome
Title Change in Triglycerides
Hide Description Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-16.82  (23.828) -26.29  (46.903)
12.Secondary Outcome
Title Change in Center for Epidemiologic Studies Scale (CES-D)
Hide 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.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.375  (2.1860) 0.2222  (2.7285)
13.Secondary Outcome
Title Change in Montreal Cognitive Assessment (MoCA)
Hide 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.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:

Oxytocin (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)

Placebo 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)

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.0000  (1.5954) 0.4444  (1.3333)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description

Oxytocin (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)

Placebo 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)

All-Cause Mortality
Oxytocin Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Oxytocin Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      9/9 (100.00%)    
Gastrointestinal disorders     
Nausea   5/12 (41.67%)  5 1/9 (11.11%)  1
Upset stomach   1/12 (8.33%)  1 0/9 (0.00%)  0
Anorexia   1/12 (8.33%)  1 0/9 (0.00%)  0
Decreased Appetite   1/12 (8.33%)  1 0/9 (0.00%)  0
Loose stool   0/12 (0.00%)  0 1/9 (11.11%)  1
Increased bowel movement   0/12 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Fatigue   0/12 (0.00%)  0 2/9 (22.22%)  2
Tiredness   0/12 (0.00%)  0 1/9 (11.11%)  1
Malaise   0/12 (0.00%)  0 1/9 (11.11%)  1
Chills   0/12 (0.00%)  0 1/9 (11.11%)  1
Flu like symptoms   0/12 (0.00%)  0 1/9 (11.11%)  1
Irritability   0/12 (0.00%)  0 1/9 (11.11%)  1
Fever   0/12 (0.00%)  0 1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders     
Neck Pain   1/12 (8.33%)  1 0/9 (0.00%)  0
Muscle Aches   1/12 (8.33%)  1 0/9 (0.00%)  0
Muscle spasms, hands   0/12 (0.00%)  0 1/9 (11.11%)  1
Muscle spasms, legs   0/12 (0.00%)  0 1/9 (11.11%)  1
Leg cramps   0/12 (0.00%)  0 1/9 (11.11%)  1
Muscle cramps   0/12 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders     
Dizziness   7/12 (58.33%)  7 2/9 (22.22%)  2
Headache   4/12 (33.33%)  4 3/9 (33.33%)  3
Lightheaded   2/12 (16.67%)  2 0/9 (0.00%)  0
Confusion   1/12 (8.33%)  1 0/9 (0.00%)  0
Delirium   0/12 (0.00%)  0 1/9 (11.11%)  1
Migraine   1/12 (8.33%)  1 0/9 (0.00%)  0
Renal and urinary disorders     
Bladder disturbance   0/12 (0.00%)  0 1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic Rhinitis   5/12 (41.67%)  5 0/9 (0.00%)  0
Nasal Irritation   2/12 (16.67%)  2 1/9 (11.11%)  1
Sinus Disorder   1/12 (8.33%)  1 0/9 (0.00%)  0
Postnasal Drip   0/12 (0.00%)  0 1/9 (11.11%)  1
Sore Throat   2/12 (16.67%)  2 0/9 (0.00%)  0
Cough   0/12 (0.00%)  0 1/9 (11.11%)  1
Throat itching   1/12 (8.33%)  1 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin Rash   1/12 (8.33%)  1 0/9 (0.00%)  0
Vascular disorders     
Bruise related to biopsy   1/12 (8.33%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Espinoza, MD
Organization: UT Health San Antonio
Phone: 210-617-5197
EMail: espinozas2@uthscsa.edu
Layout table for additonal information
Responsible Party: Sara Espinoza, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03119610    
Other Study ID Numbers: HSC20160661H
First Submitted: March 22, 2017
First Posted: April 18, 2017
Results First Submitted: August 24, 2020
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020