Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
About this trial
This is an interventional other trial for Polycystic Kidney, Autosomal Dominant focused on measuring Timed Feeding, Kidney Diseases, Body Weight
Eligibility Criteria
Inclusion Criteria:
- Aged 18-65 years
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- BMI 25-45 kg/m^2
- Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate ≥30 mL/min/1.73 m^2
- Access to the internet with video chat capabilities and smartphone
- Typical eating duration >12 hrs/day
- Not currently participating in another interventional study or weight loss program
- Ability to provide informed consent
Exclusion Criteria:
- Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%)
- Current nicotine use or history of use in the past 12 months
- Alcohol or substance abuse (self-report or undergoing treatment)
- History of hospitalization or major surgery within the last 3 months
- Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL)
- Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)
- Pregnancy, lactation, or unwillingness to use adequate birth control
- 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)
- Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease
- 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 physician 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
- History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS)-2653 will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
- 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.
- 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.
- Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on the Beck Depression Inventory will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
- 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.
- Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Sites / Locations
- University of Colorado - Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Time Restricted Feeding
Healthy Eating Advice without Time Restricted Feeding
Instructed to eat within an 8-hr window, beginning within 3 hrs of waking. In addition, provide current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.
Curriculum for the healthy eating control group will emphasize current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.