Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05514184
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2022-08-18
Brief Title:
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease PLAFOND Study A PilotFeasibility Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAFOND
Brief Summary:
In this pilot clinical trial the investigators will recruit and randomize 120 patients with diabetes mellitus and chronic kidney disease CKDDM stages 3 to 5 to a patient-centered and flexible Plant-Focused Nutrition in Diabetes PLAFOND diet with 23 plant-based sources which will be compared with a standard-of-care CKD diet which is usually a low-potassium and low-salt diet over a 6-month period Through this study the investigators will determine whether the plant-focused diet intervention is feasible for patient adherence whether this diet is safe by avoiding malnutrition frailty and high potassium or glucose blood levels and whether patient reported outcomes are favorably impacted
Detailed Description:
Chronic kidney disease CKD affects 10-15 of US adults including 30-40 of persons with diabetes mellitus DM is associated with poor outcomes and often progresses to requiring dialysis or transplantation Half of all Americans with CKD also have DM While traditional and emerging pharmacotherapies are often used in CKD with diabetes CKDDM the synergistic role of dietary interventions has not been well examined Low-carbohydrate low-fat diets are often recommended in DM whereas low-protein diets LPDs are recommended for non-diabetic CKD with increasing emphasis on plant-based protein sources Evidence suggests that high-protein diets with greater animal protein content may lead to glomerular hyperfiltration and faster decline in renal function in patients with CKDDM There remains major controversy regarding the potential risks vs benefits of plant-based diets in CKDDM for which guidelines remain based on expert opinion Given conventional dietary restrictions for the management of DM there is concern that plant-based LPDs may lead to protein-energy wasting and hyperkalemia whereas these diets may indeed be most beneficial in patients with CKDDM given their faster rates of CKD progression as compared to non-diabetics At present clinical practice guidelines provide conflicting recommendations regarding the amount low vs high and source plant vs animal of dietary protein intake DPI in CKDDM Given that prior dietary trials in CKD such as the 1994 Modification of Diet in Renal Disease MDRD study excluded CKDDM and did not examine the optimal proportion of plant vs animal-based proteins there is urgent unmet need for a rigorous dietary intervention study to examine the efficacy and safety of patient-centered plant-based diets in CKDDM
The investigators will conduct a pilot feasibility randomized controlled trial in parallel with patients routine follow-up visits at ambulatory clinics to test the feasibility and safety of implementing a Plant- Focused Nutrition in CKDDM PLAFOND diet with a DPI of 06-08 gkgd comprised of 23 plant-based sources vs standard-of-care renal diet with 13 plant-sources and low-potassium content administrated by dietitians over a 6-month period in 120 patients with CKDDM stage 3-5 The investigators will determine whether the PLAFOND diet vs the standard-of-care renal diet can be adhered to with consistent separation in dietary protein and plant-based proportions at 3- and 6-months The investigators will also examine nutritional status physical performance and body composition as well as glycemic measures using traditional metrics and continuous glucose monitoring while other biochemical parameters and patient-reported outcomes including CKD-related symptoms will also be studied In addition to providing the requisite feasibility and safety data of patient-conduct of future multi-center trials this study will have major immediate impact by reinvigorating the critical role of dietary management of CKDDM
The investigators will conduct a pilot feasibility randomized controlled trial in parallel with patients routine follow-up visits at ambulatory clinics to test the feasibility and safety of implementing a Plant- Focused Nutrition in CKDDM PLAFOND diet with a DPI of 06-08 gkgd comprised of 23 plant-based sources vs standard-of-care renal diet with 13 plant-sources and low-potassium content administrated by dietitians over a 6-month period in 120 patients with CKDDM stage 3-5 The investigators will determine whether the PLAFOND diet vs the standard-of-care renal diet can be adhered to with consistent separation in dietary protein and plant-based proportions at 3- and 6-months The investigators will also examine nutritional status physical performance and body composition as well as glycemic measures using traditional metrics and continuous glucose monitoring while other biochemical parameters and patient-reported outcomes including CKD-related symptoms will also be studied In addition to providing the requisite feasibility and safety data of patient-conduct of future multi-center trials this study will have major immediate impact by reinvigorating the critical role of dietary management of CKDDM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None