Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation

NCT04698408 | Unknown

• 1 other identifier: METc2020/050
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Kidney transplant recipients (KTR) have a considerably lower life expectancy as compared with the general population, primarily due to a high prevalence of cardiovascular diseases. KTR often develop an unfavourable cardio-metabolic risk profile characterized by weight gain, metabolic syndrome and post-transplantation diabetes mellitus (PTDM). In general, nutrition plays a key role in both the prevention and treatment of these cardio-metabolic derangements. However, in KTR most RCT's with a dietary intervention, failed to show significant improvement in cardio-metabolic health. This at least questions the efficacy of the diets of these intervention, which relied on general or diabetes guidelines, after kidney transplantation. KTR not only face a high cardio-metabolic risk, but also have a high risk for malnutrition and muscle mass depletion. More knowledge is required to determine the optimal diet and macronutrient composition for improvement of the cardio-metabolic risk factors in the context of the high malnutrition risk. In this regard, observational studies point towards the needs for a higher protein intake for better patient outcomes. Therefore, in this study, the investigators will examine if a high-protein, carbohydrate-reduced diet is more effective than a diet in line with the Dutch Dietary Guidelines for improvement of cardio-metabolic risk factors and for improvement of the body composition in KTR.

Conditions

Kidney Transplant; Complications

Keywords

kidney transplantation; metabolic syndrome; high-protein diet; dietary intervention

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Change in systolic blood pressure (in mmHg)

  before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

Secondary Outcomes (14)

• Cardio-metabolic risk factors (lipids)

  before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

• Cardio-metabolic risk factors (diastolic blood pressure)

  before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

• Cardio-metabolic risk factors (waist circumference)

  before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

• Cardio-metabolic risk factors (insulin resistance)

  before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

• Body composition

  before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

Study Arms (2)

high-protein, carbohydrate-reduced diet

EXPERIMENTAL

Other: high-protein, carbohydrate-reduced diet

Dutch Nutritional Guidelines

ACTIVE COMPARATOR

Other: Dutch Nutritional Guidelines

Interventions

high-protein, carbohydrate-reduced diet OTHER

the high-protein, carbohydrate-reduced diet will consist of 1.2-1.4 g/kg/d protein, 26-20en% carbohydrates and +/- 50en% fatty acids, with mainly unsaturated fatty acids. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.

high-protein, carbohydrate-reduced diet

Dutch Nutritional Guidelines OTHER

the diet according to the Dutch Nutritional Guidelines will consist of a protein intake of 0.8-1.0 g/kg/d and 50-60en% carbohydrates, and +/-30en% fatty acids, with restriction of saturated fatty acids \<10en%. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.

Dutch Nutritional Guidelines

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Given informed consent.
• At least 6 months after kidney transplantation.
• Stable renal function with an estimated glomerular filtration rate (eGFR) \> 30 mL/min.
• Raised systolic blood pressure (≥130 mmHg) and at least two more features of metabolic syndrome: central obesity (waist circumference ≥102 for men and ≥88cm for women), elevated triglycerides (≥ 1.7 mmol/L), reduced HDL-C (\< 1.0 mmol/L for men and \< 1.3 mmol/L for women) or on drug treatment for reduced HDL, elevated plasma glucose (≥ 5.6 mmol/L) or on drug treatment for elevated glucose9.
• Approval by nephrologist for participation in the study.

You may not qualify if:

• Active medical illness, including rejection of the graft.
• Psychopathology or serious cognitive impairment.
• Necessity to follow specific dietary measures for health purposes that conflict with the study diets.
• Use of insulin or sulfonylurea (SU)-derivates.
• Language barrier.
• Pregnancy or lactating.
• Serum potassium \> 5.0 mmol/L that requires dietary measures.
• Moderate or severe malnutrition (Patient-Generated Subjective Global Assessment (PG-SGA) stage B or C). In this case, patient will be referred to a renal dietician.
• Participation in other intervention trials.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 6, 2021

Record last verified: 2021-01