Exercise, Insulin
Conditions
Keywords
Intranasal Insulin, Cognition, Exercise, Physical Activity
Brief summary
To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.
Detailed description
Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.
Interventions
DRUGPlacebo into the intranasal mucosa
6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
DRUG20 IU NovoLog Insulin aspart into the intranasal mucosa
5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
DRUG40 IU NovoLog Insulin aspart into the intranasal mucosa
4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
DRUG60 IU NovoLog Insulin aspart into the intranasal mucosa
3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
DRUG80 IU NovoLog Insulin aspart into the intranasal mucosa
2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
DRUG100 IU NovoLog Insulin aspart into the intranasal mucosa
1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
DRUG120 IU NovoLog Insulin aspart into the intranasal mucosa
6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Sponsors
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind, placebo controlled trial
Intervention model description
Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants must be over the age of 18.. 2. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.
Exclusion criteria
1. Lack of consent. 2. Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire. 3. Type I or Type II Diabetes 4. Self-reported pregnancy 5. Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | During the 20 minute exercise/control period and the cognitive assessments. | The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms. |
| Number of Participants With Manifestation of Any Symptom Following the Protocol | Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments) | The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose. |
| Effect Size for Change in Behavioral Index of Inhibitory Control - RT | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size of Change in Behavioral Index of Sustained Attention - RT | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | Prior to intranasal insulin administration relative to 30 minutes following | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the mid-Michigan area.
Pre-assignment details
177 individuals were assessed for eligibility. 61 individuals were excluded (58 for failing medical screening, 1 diabetic, 1 unable to exercise, 1 history of epilepsy) 116 individuals were randomized using a serial stratification approach.
Participants by arm
| Arm | Count |
|---|---|
| Passive Control - Placebo 20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Passive Control - 20 IU 20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Passive Control - 40 IU 20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 9 |
| Passive Control - 60 IU 20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Passive Control - 80 IU 20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Passive Control - 100 IU 20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 9 |
| Passive Control - 120 IU 20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Acute Exercise - Placebo 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 10 |
| Acute Exercise - 20 IU 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Acute Exercise - 40 IU 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 8 |
| Acute Exercise - 60 IU 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 7 |
| Acute Exercise - 80 IU 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 7 |
| Acute Exercise - 100 IU 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 9 |
| Acute Exercise - 120 IU 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 9 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Condition stopped due to Blood Sugar Below 70 mg/dL | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Equipment Failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Report of Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Passive Control - Placebo | Total | Acute Exercise - 120 IU | Acute Exercise - 100 IU | Acute Exercise - 80 IU | Acute Exercise - 60 IU | Acute Exercise - 40 IU | Acute Exercise - 20 IU | Acute Exercise - Placebo | Passive Control - 120 IU | Passive Control - 100 IU | Passive Control - 80 IU | Passive Control - 60 IU | Passive Control - 40 IU | Passive Control - 20 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aerobic fitness percentile | 44.7 percentile STANDARD_DEVIATION 28.8 | 46.9 percentile STANDARD_DEVIATION 24.8 | 28.8 percentile STANDARD_DEVIATION 10 | 71.8 percentile STANDARD_DEVIATION 23.2 | 55.8 percentile STANDARD_DEVIATION 23.2 | 52.0 percentile STANDARD_DEVIATION 28.5 | 48.7 percentile STANDARD_DEVIATION 34.5 | 45.2 percentile STANDARD_DEVIATION 23.7 | 59.2 percentile STANDARD_DEVIATION 26.9 | 41.7 percentile STANDARD_DEVIATION 26.9 | 53.6 percentile STANDARD_DEVIATION 36.3 | 35.9 percentile STANDARD_DEVIATION 23.1 | 54.5 percentile STANDARD_DEVIATION 24 | 68.5 percentile STANDARD_DEVIATION 12.9 | 26.2 percentile STANDARD_DEVIATION 10.7 |
| Age, Continuous | 20.8 years STANDARD_DEVIATION 2 | 20.7 years STANDARD_DEVIATION 2.5 | 20.1 years STANDARD_DEVIATION 2.4 | 20.1 years STANDARD_DEVIATION 1.4 | 20.2 years STANDARD_DEVIATION 1.8 | 21.3 years STANDARD_DEVIATION 3.9 | 21.8 years STANDARD_DEVIATION 3.9 | 19.9 years STANDARD_DEVIATION 1.5 | 19.8 years STANDARD_DEVIATION 1.5 | 23.1 years STANDARD_DEVIATION 3.9 | 20.8 years STANDARD_DEVIATION 2.5 | 19.6 years STANDARD_DEVIATION 1.3 | 21.9 years STANDARD_DEVIATION 3.1 | 20.0 years STANDARD_DEVIATION 0.9 | 20.7 years STANDARD_DEVIATION 1.4 |
| Education | 14.4 years STANDARD_DEVIATION 1.9 | 13.9 years STANDARD_DEVIATION 2.2 | 13.2 years STANDARD_DEVIATION 1.9 | 13.4 years STANDARD_DEVIATION 1.4 | 13.7 years STANDARD_DEVIATION 2.1 | 14.0 years STANDARD_DEVIATION 2.8 | 15.1 years STANDARD_DEVIATION 3.4 | 13.2 years STANDARD_DEVIATION 1.9 | 13.0 years STANDARD_DEVIATION 1.1 | 15.6 years STANDARD_DEVIATION 2.6 | 13.4 years STANDARD_DEVIATION 2.3 | 13.6 years STANDARD_DEVIATION 2.7 | 14.4 years STANDARD_DEVIATION 2.8 | 13.7 years STANDARD_DEVIATION 1.2 | 14.2 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 109 Participants | 9 Participants | 9 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants | 10 Participants | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting blood glucose (mg/dL) | 94.1 mg/dL STANDARD_DEVIATION 6.9 | 94.6 mg/dL STANDARD_DEVIATION 8.6 | 96.0 mg/dL STANDARD_DEVIATION 9.5 | 92.7 mg/dL STANDARD_DEVIATION 9.6 | 96.3 mg/dL STANDARD_DEVIATION 7.3 | 93.1 mg/dL STANDARD_DEVIATION 9.3 | 87.1 mg/dL STANDARD_DEVIATION 9.6 | 97.4 mg/dL STANDARD_DEVIATION 7.9 | 92.2 mg/dL STANDARD_DEVIATION 9.4 | 97.8 mg/dL STANDARD_DEVIATION 7.3 | 94.4 mg/dL STANDARD_DEVIATION 9.4 | 96.4 mg/dL STANDARD_DEVIATION 6.5 | 91.9 mg/dL STANDARD_DEVIATION 3.5 | 99.0 mg/dL STANDARD_DEVIATION 9.3 | 96.0 mg/dL STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 9 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 96 Participants | 8 Participants | 9 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 8 Participants | 6 Participants | 9 Participants | 6 Participants | 5 Participants | 8 Participants | 7 Participants |
| Region of Enrollment United States | 8 Participants | 116 Participants | 9 Participants | 9 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 10 Participants | 8 Participants | 9 Participants | 8 Participants | 8 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 72 Participants | 5 Participants | 6 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 44 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| WASI-II (IQ) | 104.7 units on a scale STANDARD_DEVIATION 6.6 | 107.5 units on a scale STANDARD_DEVIATION 9.9 | 101.2 units on a scale STANDARD_DEVIATION 17.8 | 108.2 units on a scale STANDARD_DEVIATION 16.8 | 103.5 units on a scale STANDARD_DEVIATION 8.7 | 110.8 units on a scale STANDARD_DEVIATION 4.1 | 107.7 units on a scale STANDARD_DEVIATION 8 | 110.8 units on a scale STANDARD_DEVIATION 18.8 | 104.4 units on a scale STANDARD_DEVIATION 4.3 | 110.7 units on a scale STANDARD_DEVIATION 10.5 | 120.6 units on a scale STANDARD_DEVIATION 12.7 | 113.6 units on a scale STANDARD_DEVIATION 10.1 | 110.0 units on a scale STANDARD_DEVIATION 6.4 | 98.3 units on a scale STANDARD_DEVIATION 8.1 | 105.0 units on a scale STANDARD_DEVIATION 7.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 10 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 7 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 1 / 10 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 7 | 1 / 9 | 2 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 10 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 7 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.03 cohens d |
| Passive Control - 20 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | 0.16 cohens d |
| Passive Control - 40 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.04 cohens d |
| Passive Control - 60 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.19 cohens d |
| Passive Control - 80 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.06 cohens d |
| Passive Control - 100 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.14 cohens d |
| Passive Control - 120 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.05 cohens d |
| Acute Exercise - Placebo | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | 0.05 cohens d |
| Acute Exercise - 20 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.26 cohens d |
| Acute Exercise - 40 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.12 cohens d |
| Acute Exercise - 60 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | 0.06 cohens d |
| Acute Exercise - 80 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.01 cohens d |
| Acute Exercise - 100 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | 0.01 cohens d |
| Acute Exercise - 120 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy | -0.13 cohens d |
Primary
Effect Size for Change in Behavioral Index of Inhibitory Control - RT
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.04 cohens d |
| Passive Control - 20 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.29 cohens d |
| Passive Control - 40 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.54 cohens d |
| Passive Control - 60 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.10 cohens d |
| Passive Control - 80 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.42 cohens d |
| Passive Control - 100 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.25 cohens d |
| Passive Control - 120 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.10 cohens d |
| Acute Exercise - Placebo | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.08 cohens d |
| Acute Exercise - 20 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.20 cohens d |
| Acute Exercise - 40 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.25 cohens d |
| Acute Exercise - 60 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.33 cohens d |
| Acute Exercise - 80 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.19 cohens d |
| Acute Exercise - 100 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.27 cohens d |
| Acute Exercise - 120 IU | Effect Size for Change in Behavioral Index of Inhibitory Control - RT | -0.36 cohens d |
Primary
Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.69 cohens d |
| Passive Control - 20 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.81 cohens d |
| Passive Control - 40 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.05 cohens d |
| Passive Control - 60 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.87 cohens d |
| Passive Control - 80 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.62 cohens d |
| Passive Control - 100 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.71 cohens d |
| Passive Control - 120 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.69 cohens d |
| Acute Exercise - Placebo | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.54 cohens d |
| Acute Exercise - 20 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.36 cohens d |
| Acute Exercise - 40 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | -0.21 cohens d |
| Acute Exercise - 60 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.78 cohens d |
| Acute Exercise - 80 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.43 cohens d |
| Acute Exercise - 100 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.90 cohens d |
| Acute Exercise - 120 IU | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy | 0.60 cohens d |
Primary
Effect Size of Change in Behavioral Index of Sustained Attention - RT
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.18 cohens d |
| Passive Control - 20 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.16 cohens d |
| Passive Control - 40 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.15 cohens d |
| Passive Control - 60 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.24 cohens d |
| Passive Control - 80 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.20 cohens d |
| Passive Control - 100 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.22 cohens d |
| Passive Control - 120 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.11 cohens d |
| Acute Exercise - Placebo | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.16 cohens d |
| Acute Exercise - 20 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.05 cohens d |
| Acute Exercise - 40 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.16 cohens d |
| Acute Exercise - 60 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.18 cohens d |
| Acute Exercise - 80 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.09 cohens d |
| Acute Exercise - 100 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.19 cohens d |
| Acute Exercise - 120 IU | Effect Size of Change in Behavioral Index of Sustained Attention - RT | -0.16 cohens d |
Primary
Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.07 cohens d |
| Passive Control - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | -0.08 cohens d |
| Passive Control - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | -0.01 cohens d |
| Passive Control - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.00 cohens d |
| Passive Control - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.00 cohens d |
| Passive Control - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | -0.06 cohens d |
| Passive Control - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.00 cohens d |
| Acute Exercise - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.00 cohens d |
| Acute Exercise - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.00 cohens d |
| Acute Exercise - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | -0.04 cohens d |
| Acute Exercise - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.01 cohens d |
| Acute Exercise - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | -0.03 cohens d |
| Acute Exercise - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.00 cohens d |
| Acute Exercise - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task | 0.15 cohens d |
Primary
Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | -0.02 cohens d |
| Passive Control - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | -0.09 cohens d |
| Passive Control - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.04 cohens d |
| Passive Control - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.23 cohens d |
| Passive Control - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.02 cohens d |
| Passive Control - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.16 cohens d |
| Passive Control - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.08 cohens d |
| Acute Exercise - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.03 cohens d |
| Acute Exercise - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.02 cohens d |
| Acute Exercise - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.02 cohens d |
| Acute Exercise - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.18 cohens d |
| Acute Exercise - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | 0.04 cohens d |
| Acute Exercise - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | -0.03 cohens d |
| Acute Exercise - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task | -0.06 cohens d |
Primary
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.22 cohens d |
| Passive Control - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.06 cohens d |
| Passive Control - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 0.16 cohens d |
| Passive Control - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 0.15 cohens d |
| Passive Control - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.42 cohens d |
| Passive Control - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 0.06 cohens d |
| Passive Control - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.05 cohens d |
| Acute Exercise - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.21 cohens d |
| Acute Exercise - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.03 cohens d |
| Acute Exercise - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.25 cohens d |
| Acute Exercise - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | -0.41 cohens d |
| Acute Exercise - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 0.12 cohens d |
| Acute Exercise - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 0.19 cohens d |
| Acute Exercise - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task | 0.20 cohens d |
Primary
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Passive Control - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.08 cohens d |
| Passive Control - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | -0.06 cohens d |
| Passive Control - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | -0.08 cohens d |
| Passive Control - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | -0.09 cohens d |
| Passive Control - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.26 cohens d |
| Passive Control - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.25 cohens d |
| Passive Control - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | -0.10 cohens d |
| Acute Exercise - Placebo | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | -0.03 cohens d |
| Acute Exercise - 20 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.34 cohens d |
| Acute Exercise - 40 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.00 cohens d |
| Acute Exercise - 60 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.04 cohens d |
| Acute Exercise - 80 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.05 cohens d |
| Acute Exercise - 100 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.10 cohens d |
| Acute Exercise - 120 IU | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task | 0.05 cohens d |
Primary
Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
Time frame: During the 20 minute exercise/control period and the cognitive assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Passive Control - Placebo | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 4 Participants |
| Passive Control - 20 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 6 Participants |
| Passive Control - 40 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 6 Participants |
| Passive Control - 60 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 4 Participants |
| Passive Control - 80 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 5 Participants |
| Passive Control - 100 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 9 Participants |
| Passive Control - 120 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 5 Participants |
| Acute Exercise - Placebo | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 2 Participants |
| Acute Exercise - 20 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 4 Participants |
| Acute Exercise - 40 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 3 Participants |
| Acute Exercise - 60 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 4 Participants |
| Acute Exercise - 80 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 4 Participants |
| Acute Exercise - 100 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 7 Participants |
| Acute Exercise - 120 IU | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol | 9 Participants |
Primary
Number of Participants With Manifestation of Any Symptom Following the Protocol
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.
Time frame: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Passive Control - Placebo | Number of Participants With Manifestation of Any Symptom Following the Protocol | 1 Participants |
| Passive Control - 20 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 2 Participants |
| Passive Control - 40 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 0 Participants |
| Passive Control - 60 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 2 Participants |
| Passive Control - 80 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 1 Participants |
| Passive Control - 100 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 4 Participants |
| Passive Control - 120 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 3 Participants |
| Acute Exercise - Placebo | Number of Participants With Manifestation of Any Symptom Following the Protocol | 0 Participants |
| Acute Exercise - 20 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 1 Participants |
| Acute Exercise - 40 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 2 Participants |
| Acute Exercise - 60 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 1 Participants |
| Acute Exercise - 80 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 0 Participants |
| Acute Exercise - 100 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 3 Participants |
| Acute Exercise - 120 IU | Number of Participants With Manifestation of Any Symptom Following the Protocol | 2 Participants |