Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease

NCT04579315 | Completed DMC

• 1 other identifier: H-20026376
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

As Chronic Kidney Disease (CKD) progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion. Clinically, hyperphosphatemia is associated with high mortality, vascular calcification, endothelial dysfunction and progression of left ventricular hypertrophy. Currently the treatment of hyperphosphatemia is first being initiated in stage 5 and consists of dietetic guidance to avoid dietary phosphate and treatment with oral phosphate binders. However, studies have shown important side effects to phosphate binders in terms of progression of vascular calcifications. Therefore, it might be beneficial to start the dietetic treatment with a reduction of dietary phosphate earlier in the disease stage. The aim of this project is to develop a New Nordic Renal Diet (NNRD) for CKD patients' stage 3-4 and to examine the long-term effects in a period of 26-weeks. NNRD has a high content of vegetable foods, less animal products and more local food items with a lesser content of phosphorus.

Conditions

Chronic Kidney Disease(CKD); Hyperphosphatemia; Blood Pressure

Keywords

Chronic kidney disease; CKD; Phosphorus; Nutritional intervention; New Nordic Diet

Outcome Measures

Primary Outcomes (1)

• Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups

  24-hour urine sample

  Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion

Secondary Outcomes (12)

• Difference in changes from baseline to week 26 between study groups in urinary excretion of calcium - creatinine, -urea and protein

  Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion

• Difference in changes from baseline to week 26 between study groups in blood lipids

  Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion

• Difference in changes from baseline to week 26 between study groups in FGF23, Fractional excretion of phosphorus, P-phosphate, P-calcium, P-PTH, P-1,25OH2vitamin D3 and P-albumin

  Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion

• Difference in changes from baseline to week 26 between study groups in glomerular filtration rate, as judged by P-creatinine

  Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion

• Difference in changes from baseline to week 26 between study groups in weight

  Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion

Study Arms (2)

Intervention group, NNRD group

ACTIVE COMPARATOR

Main principles of the interventional whole food approach are: * Maximum of 850 mg phosphorous/day * Protein: 0.8 g/kg/day * 80% vegetable products; 20% animal products * Maximum of 5-7 g NaCl/day (table salt) * Fresh raw products * Seasonal oriented * Fish: At least once a week * Vegetarian: At least once a week * Wide range of fruit and vegetables * Easy to follow in daily practice * Rich in flavors * Sufficient content of micro- and macronutrients

Other: Intervention group; NNRD group

Control group

NO INTERVENTION

There is no intervention, patients are following their habitual diet

Interventions

Intervention group; NNRD group OTHER

The intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume

Intervention group, NNRD group

Eligibility Criteria

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

You may qualify if:

• Age \>18
• Estimated glomerular filtration rate (eGFR) 20-45 ml/min
• Medically stable for two months prior to study start
• Written and verbally information is given
• Read, speak and understands Danish
• Written consent

You may not qualify if:

• Treatment with phosphate binders
• Metabolic disorders that requires specific dietary regulation
• Treatment with chemotherapy within the past 6 months
• Pregnancy and breastfeeding
• Food allergies
• Vegans

Sponsors & Collaborators

• Bo Feldt-Rasmussen: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• Misella Hansen N, Kamper AL, Rix M, Feldt-Rasmussen B, Leipziger J, Sorensen MV, Berg P, Astrup A, Salomo L. Health effects of the New Nordic Renal Diet in patients with stage 3 and 4 chronic kidney disease, compared with habitual diet: a randomized trial. Am J Clin Nutr. 2023 Nov;118(5):1042-1054. doi: 10.1016/j.ajcnut.2023.08.008. Epub 2023 Aug 19.

  PMID: 37598748 DERIVED

• Hansen NM, Rix M, Kamper AL, Feldt-Rasmussen B, Christoffersen C, Astrup A, Salomo L. Study protocol: long-term effect of the New Nordic Renal Diet on phosphorus and lipid homeostasis in patients with chronic kidney disease, stages 3 and 4: a randomised controlled trial. BMJ Open. 2021 Aug 30;11(8):e045754. doi: 10.1136/bmjopen-2020-045754.

  PMID: 34462278 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bo Feldt-Rasmussen, Professor

  Department of Nephrology, Rigshospitalet, Copenhagen Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc

Model Details: Two arms, one intervention group and one control group

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: November 30, 2020
• Primary Completion: August 30, 2022
• Study Completion: November 30, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)