Polycystic Kidney, Autosomal Dominant
Conditions
Brief summary
The proposed research will determine the feasibility of delivering two behavioral weight loss interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will also compare these two interventions in terms of safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight into a) biological changes and b) changes in kidney growth with each of the two weight loss interventions.
Detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled renal cysts that ultimately result in renal failure. Similar to the general population, the prevalence of overweight and obesity have been rising in ADPKD patients, effecting about two-thirds of individuals. Surprisingly, the role of obesity in ADPKD progression is currently unknown. The investigators have novel preliminary data that overweight and obesity are independently associated with substantially faster kidney growth in ADPKD patients. Furthermore, in rodent models of ADPKD, mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function via mechanisms including AMPK-activated kinase pathway activation and suppression of mammalian target of rapamycin/S6 kinase signaling and insulin-like growth factor-1 levels. Collectively, these data suggest that dietary restriction regimens may slow ADPKD progression. Accordingly, the primary aim is to determine the feasibility of delivering a 1 year behavioral weight loss intervention program in 30 overweight/obese adults with ADPKD, based on either daily caloric restriction (DCR) or intermittent fasting (IMF), with a similar (\ 34%) targeted weekly energy deficit. A key secondary goal is to evaluate safety, acceptability, and tolerability of IMF in ADPKD versus DCR. Last, the third exploratory aim is to a) obtain mechanistic insight into biological pathways that may be altered and b) provide initial insight into any changes in total kidney volume by magnetic resonance imaging with IMF and/or DCR.
Interventions
BEHAVIORALWeight Loss
Weight loss behavioral intervention via one of two strategies.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-65 years 2. ADPKD diagnosis based on the modified Pei-Ravine criteria 3. BMI 25-45 kg/m\^2 4. Normal to mildly declined renal function with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 by the CKD-EPI equation 5. Access to the internet with video chat capabilities 6. No plans for extended travel (\>2 weeks) during the 3 month intesive period 7. Not currently participating in another interventional study or weight loss program 8. Ability to provide informed consent
Exclusion criteria
1. Diabetes mellitus (diagnosis or fasting glucose \>126 mg/dL or Hemoglobin A1C \>6.5%) 2. Current nicotine use or history of use in the past 12 months 3. Alcohol or substance abuse (self-report or undergoing treatment) 4. History of hospitalization or major surgery within the last 3 months 5. Untreated dyslipidemia (low density lipoprotein cholesterol \> 190 mg/dL or triglycerides \>400 mg/dL) 6. Uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \>100 mm Hg) 7. Pregnancy, lactation, or unwillingness to use adequate birth control 8. Cardiovascular disease, peripheral vascular disease, cerebrovascular disease, significant pulmonary or gastrointestinal disease (described below), cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis) 9. Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects 10. Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease 11. Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma 12. Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants; Study M.D. will be consulted as needed; antibiotics started during the intervention period are not an exclusion); regular use of obesity pharmacotherapeutic agents within the last 6 month 13. History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder 14. Weight loss \>5% in past 3 months for any reason except post-partum weight loss; weight gain \>5% in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study. 15. Untreated hyper- or hyperthyroidism (TSH outside of normal range for laboratory or history of uncontrolled thyroid disorder). History of thyroid disorder or current thyroid disease treated with stable medication regimen for at least 6 months in acceptable. 16. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. 17. History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions. 18. Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility to Enroll and Retain Participants | Through study completion, an expected duration of 18 months | Numbers of individuals pre-screened |
| Feasibility to Enroll Participants | Through study completion, an expected duration of 18 months | Numbers of individuals screened |
| Feasibility to Retain Participants | Through study completion, an expected duration of 18 months | Numbers of individuals enrolled |
| Percent Change From Baseline Body Weight (Weight Loss) | Baseline, 12 weeks, and 1 year | Measurement of body weight pre to post intervention in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood at Baseline | 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. |
| Mood at 12 Weeks | 12 Weeks | 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. |
| Mood at 1 Year | 1 Year | 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. |
| Change in Energy Intake | Baseline, 12 weeks and 1 year | Self-reported energy intake |
| Change in Macronutrient Intake | Baseline, 12 weeks and 1 year | Self-reported macronutrient intake |
| Serum Insulin-like Growth Factor-1 Levels at Baseline | Baseline | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group |
| Serum Insulin-like Growth Factor-1 Levels at 12 Weeks | 12 Weeks | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group |
| Safety and Tolerability, Measured as Adverse Events | 1 year | Number of participants with treatment-related adverse events in each group as evaluated by monthly phone questionnaire |
| Insulin-like Growth Factor Binding Protein-1 Levels at Baseline | Baseline | Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group |
| Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks | 12 Weeks | Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group |
| Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year | 1 Year | Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group |
| Change in PBMC Ratio of pS6K/s6K | Baseline and 1 year | Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group. |
| Change in PBMC pAMPK/AMPK Expression | Baseline and 1 year | Ratio of peripheral blood mononuclear cell protein expression of phosphorylated AMP-activated kinase (AMPK) to AMPK in each group |
| Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI) | Baseline and 1 year | Percent change from baseline in height adjusted total kidney volume by MRI in each group |
| Serum Insulin-like Growth Factor-1 Levels at 1 Year | 1 Year | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group |
| Quality of Life Scores at Baseline | 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. |
| Quality of Life Scores at 12 Weeks | 12 Weeks | 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. |
| Quality of Life Scores at 1 Year | 1 Year | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant dropped out prior to randomization. This individual is included in the protocol enrollment number, but not the number of participants started.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 13 |
| Total | 28 |
Baseline characteristics
| Characteristic | Intermittent Fasting | Total | Daily Caloric Restriction |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 6 | 46 years STANDARD_DEVIATION 9 | 47 years STANDARD_DEVIATION 12 |
| Body Mass Index | 34.8 kg/m^2 STANDARD_DEVIATION 5.1 | 34.7 kg/m^2 STANDARD_DEVIATION 5 | 34.6 kg/m^2 STANDARD_DEVIATION 5.1 |
| CKD-EPI eGFR | 75 ml/minute/1.73m^2 STANDARD_DEVIATION 16 | 69 ml/minute/1.73m^2 STANDARD_DEVIATION 22 | 64 ml/minute/1.73m^2 STANDARD_DEVIATION 26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 27 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Region of Enrollment United States | 13 participants | 28 participants | 15 participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
| Total Kidney Volume by Magnetic Resonance Imaging (MRI) | 835 ml/m | 916 ml/m | 994 ml/m |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 10 / 15 | 13 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 |
Outcome results
Primary
Feasibility to Enroll and Retain Participants
Numbers of individuals pre-screened
Time frame: Through study completion, an expected duration of 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Feasibility to Enroll and Retain Participants | 122 Participants |
Primary
Feasibility to Enroll Participants
Numbers of individuals screened
Time frame: Through study completion, an expected duration of 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Feasibility to Enroll Participants | 29 Participants |
Primary
Feasibility to Retain Participants
Numbers of individuals retained
Time frame: Through study completion, an expected duration of 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Feasibility to Retain Participants | 13 Participants |
| Intermittent Fasting | Feasibility to Retain Participants | 11 Participants |
Primary
Feasibility to Retain Participants
Numbers of individuals enrolled
Time frame: Through study completion, an expected duration of 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Feasibility to Retain Participants | 15 Participants |
| Intermittent Fasting | Feasibility to Retain Participants | 13 Participants |
Primary
Percent Change From Baseline Body Weight (Weight Loss)
Measurement of body weight pre to post intervention in each group
Time frame: Baseline, 12 weeks, and 1 year
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Percent Change From Baseline Body Weight (Weight Loss) | 12 Weeks | -7.1 Percent change in weight | Standard Deviation 4.2 |
| Overall Study | Percent Change From Baseline Body Weight (Weight Loss) | 1 Year | -9.1 Percent change in weight | Standard Deviation 6 |
| Intermittent Fasting | Percent Change From Baseline Body Weight (Weight Loss) | 12 Weeks | -5.5 Percent change in weight | Standard Deviation 3.3 |
| Intermittent Fasting | Percent Change From Baseline Body Weight (Weight Loss) | 1 Year | -4.9 Percent change in weight | Standard Deviation 5.6 |
Secondary
Change in Energy Intake
Self-reported energy intake
Time frame: Baseline, 12 weeks and 1 year
Population: This outcome is not reported because the data were not collected.
Secondary
Change in Macronutrient Intake
Self-reported macronutrient intake
Time frame: Baseline, 12 weeks and 1 year
Population: This outcome is not reported because the data were not collected.
Secondary
Change in PBMC pAMPK/AMPK Expression
Ratio of peripheral blood mononuclear cell protein expression of phosphorylated AMP-activated kinase (AMPK) to AMPK in each group
Time frame: Baseline and 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change in PBMC pAMPK/AMPK Expression | Baseline | 0.49 ratio | Standard Deviation 0.31 |
| Overall Study | Change in PBMC pAMPK/AMPK Expression | Change at 1 Year | 0.12 ratio | Standard Deviation 0.15 |
| Intermittent Fasting | Change in PBMC pAMPK/AMPK Expression | Baseline | .76 ratio | Standard Deviation 0.44 |
| Intermittent Fasting | Change in PBMC pAMPK/AMPK Expression | Change at 1 Year | -0.25 ratio | Standard Deviation 0.42 |
Secondary
Change in PBMC Ratio of pS6K/s6K
Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group.
Time frame: Baseline and 1 year
Population: Not all participants could be analyzed for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change in PBMC Ratio of pS6K/s6K | Baseline | 0.89 ratio | Standard Deviation 0.39 |
| Overall Study | Change in PBMC Ratio of pS6K/s6K | Change at 1 year | 0.42 ratio | Standard Deviation 0.89 |
| Intermittent Fasting | Change in PBMC Ratio of pS6K/s6K | Baseline | 1.43 ratio | Standard Deviation 1.17 |
| Intermittent Fasting | Change in PBMC Ratio of pS6K/s6K | Change at 1 year | -0.27 ratio | Standard Deviation 0.58 |
Secondary
Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Time frame: 12 Weeks
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks | 11.1 ng/ml |
| Intermittent Fasting | Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks | 8.7 ng/ml |
Secondary
Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Time frame: 1 Year
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year | 10.0 ng/ml |
| Intermittent Fasting | Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year | 7.9 ng/ml |
Secondary
Insulin-like Growth Factor Binding Protein-1 Levels at Baseline
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Insulin-like Growth Factor Binding Protein-1 Levels at Baseline | 9.4 ng/ml |
| Intermittent Fasting | Insulin-like Growth Factor Binding Protein-1 Levels at Baseline | 7.5 ng/ml |
Secondary
Mood at 12 Weeks
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.
Time frame: 12 Weeks
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Mood at 12 Weeks | Vigor | 7.5 score on a scale | Standard Deviation 3.2 |
| Overall Study | Mood at 12 Weeks | Fatigue | 7.7 score on a scale | Standard Deviation 7.5 |
| Intermittent Fasting | Mood at 12 Weeks | Vigor | 7.3 score on a scale | Standard Deviation 4.5 |
| Intermittent Fasting | Mood at 12 Weeks | Fatigue | 6.5 score on a scale | Standard Deviation 5.4 |
Secondary
Mood at 1 Year
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.
Time frame: 1 Year
Population: This outcome measure was not collected for some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Mood at 1 Year | Vigor | 8.2 score on a scale | Standard Deviation 4.2 |
| Overall Study | Mood at 1 Year | Fatigue | 5.2 score on a scale | Standard Deviation 4.7 |
| Intermittent Fasting | Mood at 1 Year | Vigor | 7.9 score on a scale | Standard Deviation 5.6 |
| Intermittent Fasting | Mood at 1 Year | Fatigue | 6.7 score on a scale | Standard Deviation 4.8 |
Secondary
Mood at 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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Mood at Baseline | Vigor | 8.3 score on a scale | Standard Deviation 3.2 |
| Overall Study | Mood at Baseline | Fatigue | 5.2 score on a scale | Standard Deviation 5.4 |
| Intermittent Fasting | Mood at Baseline | Vigor | 7.6 score on a scale | Standard Deviation 3 |
| Intermittent Fasting | Mood at Baseline | Fatigue | 6.4 score on a scale | Standard Deviation 3.9 |
Secondary
Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI)
Percent change from baseline in height adjusted total kidney volume by MRI in each group
Time frame: Baseline and 1 year
Population: Not all participants could be analyzed for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI) | 1.54 Percent change | Standard Deviation 3.35 |
| Intermittent Fasting | Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI) | 1.70 Percent change | Standard Deviation 6.05 |
Secondary
Quality of Life Scores at 12 Weeks
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.
Time frame: 12 Weeks
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Quality of Life Scores at 12 Weeks | Physical Health | 81 score on a scale | Standard Deviation 21 |
| Overall Study | Quality of Life Scores at 12 Weeks | Mental Health | 80 score on a scale | Standard Deviation 26 |
| Intermittent Fasting | Quality of Life Scores at 12 Weeks | Physical Health | 84 score on a scale | Standard Deviation 12 |
| Intermittent Fasting | Quality of Life Scores at 12 Weeks | Mental Health | 91 score on a scale | Standard Deviation 9 |
Secondary
Quality of Life Scores at 1 Year
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.
Time frame: 1 Year
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Quality of Life Scores at 1 Year | Physical Health | 80 score on a scale | Standard Deviation 26 |
| Overall Study | Quality of Life Scores at 1 Year | Mental Health | 81 score on a scale | Standard Deviation 12 |
| Intermittent Fasting | Quality of Life Scores at 1 Year | Physical Health | 91 score on a scale | Standard Deviation 9 |
| Intermittent Fasting | Quality of Life Scores at 1 Year | Mental Health | 76 score on a scale | Standard Deviation 21 |
Secondary
Quality of Life Scores at 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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Quality of Life Scores at Baseline | Physical Health | 77 score on a scale | Standard Deviation 22 |
| Overall Study | Quality of Life Scores at Baseline | Mental Health | 82 score on a scale | Standard Deviation 10 |
| Intermittent Fasting | Quality of Life Scores at Baseline | Physical Health | 83 score on a scale | Standard Deviation 12 |
| Intermittent Fasting | Quality of Life Scores at Baseline | Mental Health | 78 score on a scale | Standard Deviation 16 |
Secondary
Safety and Tolerability, Measured as Adverse Events
Number of participants with treatment-related adverse events in each group as evaluated by monthly phone questionnaire
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Safety and Tolerability, Measured as Adverse Events | 10 Number of participants w/ adverse events |
| Intermittent Fasting | Safety and Tolerability, Measured as Adverse Events | 13 Number of participants w/ adverse events |
Secondary
Serum Insulin-like Growth Factor-1 Levels at 12 Weeks
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Time frame: 12 Weeks
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Serum Insulin-like Growth Factor-1 Levels at 12 Weeks | 127 ng/ml | Standard Deviation 41 |
| Intermittent Fasting | Serum Insulin-like Growth Factor-1 Levels at 12 Weeks | 96 ng/ml | Standard Deviation 32 |
Secondary
Serum Insulin-like Growth Factor-1 Levels at 1 Year
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Time frame: 1 Year
Population: This outcome measure could not be collected for some participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Serum Insulin-like Growth Factor-1 Levels at 1 Year | 103 ng/ml | Standard Deviation 25 |
| Intermittent Fasting | Serum Insulin-like Growth Factor-1 Levels at 1 Year | 101 ng/ml | Standard Deviation 29 |
Secondary
Serum Insulin-like Growth Factor-1 Levels at Baseline
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Serum Insulin-like Growth Factor-1 Levels at Baseline | 104 ng/ml | Standard Deviation 27 |
| Intermittent Fasting | Serum Insulin-like Growth Factor-1 Levels at Baseline | 93 ng/ml | Standard Deviation 32 |