Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

NCT04534985 | Completed

• 1 other identifier: 20-1262
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research will determine the feasibility of a time restricted feeding intervention,a fasting regimen that restricts eating to a feeding window (8 hrs/day) for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will provide valuable information on the intervention in terms of safety, adherence, acceptability, and tolerability. Last, this pilot trial will provide initial insight into biological changes including abdominal adiposity, changes in kidney growth and function, and markers of biological pathways related to the intervention.

Conditions

Polycystic Kidney, Autosomal Dominant

Keywords

Timed Feeding; Kidney Diseases; Body Weight

Outcome Measures

Primary Outcomes (3)

• Adherence

  Percent adherence to the 8-hr TRF window (during the 7 day recordng period)

  1 year

• Feasibility to enroll participants

  Numbers of individuals pre-screened and enrolled

  Through study enrollment, an expected duration of 12 months

• Feasibility to retain participants

  Numbers of individuals retained

  Through study completion, an expected duration of 24 months

Secondary Outcomes (13)

• Safety and tolerability, measured as adverse events

  Through study completion, an expected duration of 24 months

• Change in Body Weight

  1 year

• Change in Abdominal adiposity

  1 year

• Change in Body Composition

  1 year

• Change in insulin-like growth factor binding protein-1 levels

  1 year

Other Outcomes (4)

• Change in resting energy expenditure

  1 year

• Change in energy intake

  1 year

• Change in macronutrient intake

  1 year

Study Arms (2)

Time Restricted Feeding

EXPERIMENTAL

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.

Behavioral: Dietary

Healthy Eating Advice without Time Restricted Feeding

ACTIVE COMPARATOR

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.

Behavioral: Dietary

Interventions

Dietary BEHAVIORAL

Dietary intake behavioral intervention via time restricted feeding and normal healthy eating recommendations vs. normal healthy eating recommendations without restricted

Healthy Eating Advice without Time Restricted Feeding; Time Restricted Feeding

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• PKD Foundation: collaborator

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

• Chebib FT, Nowak KL, Chonchol MB, Bing K, Ghanem A, Rahbari-Oskoui FF, Dahl NK, Mrug M. Polycystic Kidney Disease Diet: What is Known and What is Safe. Clin J Am Soc Nephrol. 2024 May 1;19(5):664-682. doi: 10.2215/CJN.0000000000000326. Epub 2023 Sep 20.

  PMID: 37729939 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Kidney Diseases; Body Weight

Interventions

Diet

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kristen Nowak

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 1, 2020
• Study Start: February 9, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)