Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
Time Restricted Feeding in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado - Anschutz Medical Campus
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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.
|
Dietary intake behavioral intervention via time restricted feeding and normal healthy eating recommendations vs. normal healthy eating recommendations without restricted
|
|
Active Comparator: Healthy Eating Advice without Time Restricted Feeding
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.
|
Dietary intake behavioral intervention via time restricted feeding and normal healthy eating recommendations vs. normal healthy eating recommendations without restricted
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 1 year
|
Percent adherence to the 8-hr TRF window (during the 7 day recordng period)
|
1 year
|
|
Feasibility to enroll participants
Time Frame: Through study enrollment, an expected duration of 12 months
|
Numbers of individuals pre-screened and enrolled
|
Through study enrollment, an expected duration of 12 months
|
|
Feasibility to retain participants
Time Frame: Through study completion, an expected duration of 24 months
|
Numbers of individuals retained
|
Through study completion, an expected duration of 24 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and tolerability, measured as adverse events
Time Frame: Through study completion, an expected duration of 24 months
|
Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
|
Through study completion, an expected duration of 24 months
|
|
Change in Body Weight
Time Frame: 1 year
|
Body weight will be measured at baseline and monthly, using BodyTrace scales for remote, secure transmission of data.
|
1 year
|
|
Change in Abdominal adiposity
Time Frame: 1 year
|
Abdominal adiposity will be quantified using MRI
|
1 year
|
|
Change in Body Composition
Time Frame: 1 year
|
Body composition measured via dual-energy X-ray absorptiometry (DEXA)
|
1 year
|
|
Change in insulin-like growth factor binding protein-1 levels
Time Frame: 1 year
|
Fasting serum insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
|
1 year
|
|
Change in serum insulin-like growth factor-1 levels
Time Frame: 1 year
|
Fasting serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
|
1 year
|
|
Change in peripheral blood mononuclear cell (PBMC) AMPK expression
Time Frame: 1 year
|
Peripheral blood mononuclear cell protein expression of AMP-activated kinase (AMPK) in each group
|
1 year
|
|
Change in PBMC S6K expression
Time Frame: 1 year
|
Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group
|
1 year
|
|
Change in β-hydroxybutyrate levels
Time Frame: 1 year
|
Serum β-hydroxybutyrate levels in each group
|
1 year
|
|
Change in total kidney volume by magnetic resonance imaging (MRI)
Time Frame: 1 year
|
Change in total kidney volume by MRI in each group
|
1 year
|
|
Change in quality of life
Time Frame: 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
|
1 year
|
|
Change in mood
Time Frame: 1 year
|
Mood state will be assessed with the Profile of Mood States 2 (POMS-2)
|
1 year
|
|
Change in pain
Time Frame: 1 year
|
Modified version of the Wisconsin Brief Pain Survey
|
1 year
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in resting energy expenditure
Time Frame: 1 year
|
Standard indirect calorimetry
|
1 year
|
|
Change in energy intake
Time Frame: 1 year
|
24-hr dietary recalls will be analyzed using a random day in the 7-day photographic food record/continuous glucose monitoring collection period to evaluate self-reported energy intake
|
1 year
|
|
Change in macronutrient intake
Time Frame: 1 year
|
24-hr dietary recalls will be analyzed using a random day in the 7-day photographic food record/CGM collection period to evaluate self-reported energy intake
|
1 year
|
|
Change in self-reported physical activity
Time Frame: 1 year
|
Self-reported physical activity will be quantified using the Stanford Physical Activity Questionnaire
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Kristen Nowak, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Kidney Diseases
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Arthrogryposis
Other Study ID Numbers
Other Study ID Numbers
- 20-1262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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