Trial Outcomes & Findings for Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease (NCT NCT03342742)

Results Overview

Numbers of individuals pre-screened

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Through study completion, an expected duration of 18 months

Results posted on

2022-03-03

Participant Flow

One participant dropped out prior to randomization. This individual is included in the protocol enrollment number, but not the number of participants started.

Participant milestones

Participant milestones
Measure	Daily Caloric Restriction The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements. Weight Loss: Weight loss behavioral intervention via one of two strategies.	Intermittent Fasting Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Overall Study STARTED	15	13
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline measure could not be collected for all participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Caloric Restriction n=15 Participants The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements. Weight Loss: Weight loss behavioral intervention via one of two strategies.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.	Total n=28 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 12 • n=15 Participants	46 years STANDARD_DEVIATION 6 • n=13 Participants	46 years STANDARD_DEVIATION 9 • n=28 Participants
Sex: Female, Male Female	9 Participants n=15 Participants	7 Participants n=13 Participants	16 Participants n=28 Participants
Sex: Female, Male Male	6 Participants n=15 Participants	6 Participants n=13 Participants	12 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=15 Participants	0 Participants n=13 Participants	1 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=15 Participants	13 Participants n=13 Participants	27 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants	1 Participants n=13 Participants	1 Participants n=28 Participants
Race (NIH/OMB) White	14 Participants n=15 Participants	12 Participants n=13 Participants	26 Participants n=28 Participants
Race (NIH/OMB) More than one race	1 Participants n=15 Participants	0 Participants n=13 Participants	1 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Region of Enrollment United States	15 participants n=15 Participants	13 participants n=13 Participants	28 participants n=28 Participants
Body Mass Index	34.6 kg/m^2 STANDARD_DEVIATION 5.1 • n=15 Participants	34.8 kg/m^2 STANDARD_DEVIATION 5.1 • n=13 Participants	34.7 kg/m^2 STANDARD_DEVIATION 5.0 • n=28 Participants
CKD-EPI eGFR	64 ml/minute/1.73m^2 STANDARD_DEVIATION 26 • n=15 Participants	75 ml/minute/1.73m^2 STANDARD_DEVIATION 16 • n=13 Participants	69 ml/minute/1.73m^2 STANDARD_DEVIATION 22 • n=28 Participants
Total Kidney Volume by Magnetic Resonance Imaging (MRI)	994 ml/m n=13 Participants • This baseline measure could not be collected for all participants.	835 ml/m n=12 Participants • This baseline measure could not be collected for all participants.	916 ml/m n=25 Participants • This baseline measure could not be collected for all participants.

PRIMARY outcome

Timeframe: Through study completion, an expected duration of 18 months

Numbers of individuals pre-screened

Outcome measures

Outcome measures
Measure	Overall Study n=122 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Feasibility to Enroll and Retain Participants	122 Participants	—

PRIMARY outcome

Timeframe: Through study completion, an expected duration of 18 months

Numbers of individuals screened

Outcome measures

Outcome measures
Measure	Overall Study n=29 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Feasibility to Enroll Participants	29 Participants	—

PRIMARY outcome

Timeframe: Through study completion, an expected duration of 18 months

Numbers of individuals enrolled

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Feasibility to Retain Participants	15 Participants	13 Participants

PRIMARY outcome

Timeframe: Through study completion, an expected duration of 18 months

Numbers of individuals retained

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Feasibility to Retain Participants	13 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks, and 1 year

Population: This outcome measure could not be collected for some participants.

Measurement of body weight pre to post intervention in each group

Outcome measures

Outcome measures
Measure	Overall Study n=12 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=11 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Percent Change From Baseline Body Weight (Weight Loss) 12 Weeks	-7.1 Percent change in weight Standard Deviation 4.2	-5.5 Percent change in weight Standard Deviation 3.3
Percent Change From Baseline Body Weight (Weight Loss) 1 Year	-9.1 Percent change in weight Standard Deviation 6.0	-4.9 Percent change in weight Standard Deviation 5.6

SECONDARY outcome

Timeframe: 1 year

Number of participants with treatment-related adverse events in each group as evaluated by monthly phone questionnaire

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Safety and Tolerability, Measured as Adverse Events	10 Number of participants w/ adverse events	13 Number of participants w/ adverse events

SECONDARY outcome

Timeframe: Baseline

Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score. The Rand-36 measures quality of life. Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Quality of Life Scores at Baseline Physical Health	77 score on a scale Standard Deviation 22	83 score on a scale Standard Deviation 12
Quality of Life Scores at Baseline Mental Health	82 score on a scale Standard Deviation 10	78 score on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 12 Weeks

Population: This outcome measure could not be collected for some participants.

Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score. The Rand-36 measures quality of life. Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.

Outcome measures

Outcome measures
Measure	Overall Study n=13 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=10 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Quality of Life Scores at 12 Weeks Physical Health	81 score on a scale Standard Deviation 21	84 score on a scale Standard Deviation 12
Quality of Life Scores at 12 Weeks Mental Health	80 score on a scale Standard Deviation 26	91 score on a scale Standard Deviation 9

SECONDARY outcome

Timeframe: 1 Year

Population: This outcome measure could not be collected for some participants.

Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score. The Rand-36 measures quality of life. Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.

Outcome measures

Outcome measures
Measure	Overall Study n=11 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=11 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Quality of Life Scores at 1 Year Physical Health	80 score on a scale Standard Deviation 26	91 score on a scale Standard Deviation 9
Quality of Life Scores at 1 Year Mental Health	81 score on a scale Standard Deviation 12	76 score on a scale Standard Deviation 21

SECONDARY outcome

Timeframe: Baseline

Mood state will be assessed with the Profile of Mood States 2 (POMS-2). The POMS-2 measures mood. Possible scores for the Vigor scale range from 0 to 32, with higher scores for indicating a better outcome. Possible scores for the fatigue scale range from 0 to 28 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Mood at Baseline Vigor	8.3 score on a scale Standard Deviation 3.2	7.6 score on a scale Standard Deviation 3.0
Mood at Baseline Fatigue	5.2 score on a scale Standard Deviation 5.4	6.4 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 12 Weeks

Population: This outcome measure could not be collected for some participants.

Mood state will be assessed with the Profile of Mood States 2 (POMS-2). The POMS-2 measures mood. Possible scores range from 0 to 20 for both the Vigor and Fatigue subscales, with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Overall Study n=13 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=10 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Mood at 12 Weeks Vigor	7.5 score on a scale Standard Deviation 3.2	7.3 score on a scale Standard Deviation 4.5
Mood at 12 Weeks Fatigue	7.7 score on a scale Standard Deviation 7.5	6.5 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 1 Year

Population: This outcome measure was not collected for some participants.

Mood state will be assessed with the Profile of Mood States 2 (POMS-2). The POMS-2 measures mood. Possible scores range from 0 to 20 for both the Vigor and Fatigue subscales, with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Overall Study n=11 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=11 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Mood at 1 Year Vigor	8.2 score on a scale Standard Deviation 4.2	7.9 score on a scale Standard Deviation 5.6
Mood at 1 Year Fatigue	5.2 score on a scale Standard Deviation 4.7	6.7 score on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: Baseline, 12 weeks and 1 year

Population: This outcome is not reported because the data were not collected.

Self-reported energy intake

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks and 1 year

Population: This outcome is not reported because the data were not collected.

Self-reported macronutrient intake

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Serum Insulin-like Growth Factor-1 Levels at Baseline	104 ng/ml Standard Deviation 27	93 ng/ml Standard Deviation 32

SECONDARY outcome

Timeframe: 12 Weeks

Population: This outcome measure could not be collected for some participants.

Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group

Outcome measures

Outcome measures
Measure	Overall Study n=11 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=11 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Serum Insulin-like Growth Factor-1 Levels at 12 Weeks	127 ng/ml Standard Deviation 41	96 ng/ml Standard Deviation 32

SECONDARY outcome

Timeframe: 1 Year

Population: This outcome measure could not be collected for some participants.

Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group

Outcome measures

Outcome measures
Measure	Overall Study n=10 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=10 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Serum Insulin-like Growth Factor-1 Levels at 1 Year	103 ng/ml Standard Deviation 25	101 ng/ml Standard Deviation 29

SECONDARY outcome

Timeframe: Baseline

Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group

Outcome measures

Outcome measures
Measure	Overall Study n=15 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=13 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Insulin-like Growth Factor Binding Protein-1 Levels at Baseline	9.4 ng/ml Interval 1.8 to 15.7	7.5 ng/ml Interval 5.2 to 11.2

SECONDARY outcome

Timeframe: 12 Weeks

Population: This outcome measure could not be collected for some participants.

Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group

Outcome measures

Outcome measures
Measure	Overall Study n=11 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=11 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks	11.1 ng/ml Interval 7.4 to 26.0	8.7 ng/ml Interval 3.1 to 18.8

SECONDARY outcome

Timeframe: 1 Year

Population: This outcome measure could not be collected for some participants.

Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group

Outcome measures

Outcome measures
Measure	Overall Study n=10 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=10 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year	10.0 ng/ml Interval 5.8 to 19.6	7.9 ng/ml Interval 4.4 to 10.4

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Not all participants could be analyzed for this outcome measure

Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group.

Outcome measures

Outcome measures
Measure	Overall Study n=6 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=9 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Change in PBMC Ratio of pS6K/s6K Baseline	0.89 ratio Standard Deviation 0.39	1.43 ratio Standard Deviation 1.17
Change in PBMC Ratio of pS6K/s6K Change at 1 year	0.42 ratio Standard Deviation 0.89	-0.27 ratio Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline and 1 year

Ratio of peripheral blood mononuclear cell protein expression of phosphorylated AMP-activated kinase (AMPK) to AMPK in each group

Outcome measures

Outcome measures
Measure	Overall Study n=7 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=9 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Change in PBMC pAMPK/AMPK Expression Baseline	0.49 ratio Standard Deviation 0.31	.76 ratio Standard Deviation 0.44
Change in PBMC pAMPK/AMPK Expression Change at 1 Year	0.12 ratio Standard Deviation 0.15	-0.25 ratio Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Not all participants could be analyzed for this outcome measure

Percent change from baseline in height adjusted total kidney volume by MRI in each group

Outcome measures

Outcome measures
Measure	Overall Study n=10 Participants Pre-screened includes participants that were not randomized.	Intermittent Fasting n=10 Participants Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI)	1.54 Percent change Standard Deviation 3.35	1.70 Percent change Standard Deviation 6.05

Adverse Events

Daily Caloric Restriction

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Intermittent Fasting

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Daily Caloric Restriction n=15 participants at risk The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements. Weight Loss: Weight loss behavioral intervention via one of two strategies.	Intermittent Fasting n=13 participants at risk Participants in the intermittent fasting group will be instructed to reduce energy intake to \~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of \~34% (similar to the daily caloric restriction group). Weight Loss: Weight loss behavioral intervention via one of two strategies.
Gastrointestinal disorders Hunger	33.3% 5/15 • Number of events 5 • 1 Year	84.6% 11/13 • Number of events 11 • 1 Year
Gastrointestinal disorders Gastrointestinal distress	26.7% 4/15 • Number of events 4 • 1 Year	61.5% 8/13 • Number of events 8 • 1 Year
General disorders Fatigue	6.7% 1/15 • Number of events 1 • 1 Year	61.5% 8/13 • Number of events 8 • 1 Year
General disorders Lightheadedness/dizziness	20.0% 3/15 • Number of events 3 • 1 Year	38.5% 5/13 • Number of events 5 • 1 Year
General disorders Cold Intolerance	6.7% 1/15 • Number of events 1 • 1 Year	53.8% 7/13 • Number of events 7 • 1 Year
Psychiatric disorders Change in mood	13.3% 2/15 • Number of events 2 • 1 Year	30.8% 4/13 • Number of events 4 • 1 Year
Psychiatric disorders Irritability	6.7% 1/15 • Number of events 1 • 1 Year	46.2% 6/13 • Number of events 6 • 1 Year
Psychiatric disorders Insomnia	13.3% 2/15 • Number of events 2 • 1 Year	53.8% 7/13 • Number of events 7 • 1 Year
Nervous system disorders Headache	13.3% 2/15 • Number of events 2 • 1 Year	30.8% 4/13 • Number of events 4 • 1 Year
Psychiatric disorders Impaired concentration and/or cognitive difficulties	0.00% 0/15 • 1 Year	23.1% 3/13 • Number of events 3 • 1 Year
Nervous system disorders Tremor	0.00% 0/15 • 1 Year	7.7% 1/13 • Number of events 1 • 1 Year

Additional Information

Kristen Nowak

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place