NCT03342742.

Study name	Daily caloric restriction and intermittent fasting in overweight and obese adults with autosomal dominant polycystic kidney disease
Methods	Randomised controlled trial
Participants	28 Participants Ages eligible for study: 18 years to 65 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: no Inclusion Criteria aged 18‐65 years ADPKD diagnosis based on the modified Pei‐Ravine criteria BMI 25‐45 kg/m2 Normal to mildly declined renal function with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 by the CKD‐EPI equation Access to the internet with video chat capabilities no plans for extended travel (>2 weeks) during the 3‐month intensive period Not currently participating in another interventional study or weight loss program Ability to provide informed consent
Interventions	Arm Intervention/treatment Experimental: 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. Behavioural: weight loss Weight loss behavioural intervention via one of two strategies. Experimental: 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). Behavioural: weight loss Weight loss behavioural intervention via one of two strategies.
Outcomes	Primary outcome measures: Feasibility to enrol and retain participants [ Time Frame: Through study completion, an expected duration of 18 months ] Numbers of individuals pre‐screened Feasibility to enrol participants [ Time Frame: Through study completion, an expected duration of 18 months ] Numbers of individuals screened Feasibility to retain participants [ Time Frame: Through study completion, an expected duration of 18 months ] Numbers of individuals enrolled Feasibility to retain participants [ Time Frame: Through study completion, an expected duration of 18 months ] Numbers of individuals retained Change in Weight Loss [ Time Frame: Baseline, 12 weeks, and 1 year ] Measurement of body weight pre to post intervention in each group Secondary Outcome Measures: Safety and tolerability, measured as adverse events [ Time Frame: 12 weeks and 1 year ] Number of participants with treatment‐related adverse events in each group as evaluated by the Safety Officer Safety and tolerability, measured as treatment‐related adverse events [ Time Frame: 12 weeks and 1 year ] Number of participants with treatment‐related adverse events in each group as evaluated by the Safety Officer Changes in quality of life [ Time Frame: Baseline, 12 weeks and 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. Changes in mood [ Time Frame: Baseline, 12 weeks and 1 year ] Mood state will be assessed with the Profile of Mood States 2 (POMS‐2) Change in energy intake [ Time Frame: Baseline, 12 weeks and 1 year ] Self‐reported energy intake Change in macronutrient intake [ Time Frame: Baseline, 12 weeks and 1 year ] Self‐reported macronutrient intake Change in serum insulin‐like growth factor‐1 levels [ Time Frame: Baseline, 12 weeks and 1 year ] Serum insulin‐like growth factor‐1 (IGF‐1) levels will be evaluated in each group Change in insulin‐like growth factor binding protein‐1 levels [ Time Frame: Baseline, 12 weeks and 1 year ] Insulin‐like growth factor binding protein‐1 (IGFBP‐1) levels will be evaluated in each group Change in PBMC AMPK expression [ Time Frame: Baseline, 12 weeks and 1 year ] Peripheral blood mononuclear cell protein expression of AMP‐activated kinase (AMPK) in each group Change in PBMC S6K expression [ Time Frame: Baseline, 12 weeks and 1 year ] Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group Change in β‐hydroxybutyrate levels [ Time Frame: Baseline, 12 weeks and 1 year ] Serum β‐hydroxybutyrate levels in each group Change in total kidney volume by magnetic resonance imaging (MRI) [ Time Frame: Baseline, 12 weeks and 1 year ] Change in total kidney volume by MRI in each group
Starting date	June 4, 2018
Contact information	Kristen Nowak, Ph.D., MPHUniversity of Colorado ‐ Anschutz Medical Campus
Notes	NCT03342742