Diet Rich in N-3 Polyunsaturated Fatty Acids in Renal Transplant Recipients

NCT01872455 | Completed Phase 4 DMC

• 2 other identifiers: TX13TX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

n-3 Polyunsaturated fatty acids (PUFAs) supplementation reduces systemic inflammation and improves renal and cardiovascular prognosis in kidney transplant recipients. A good patient compliance is often difficult to obtain because bad tasting fish oils are used as n-3 PUFA source. Therefore, we explored whether n-3 beneficial effects can be obtained by administering a diet based on n-3 rich foods.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (3)

• Nutritional assessment

  Anthropometric, body composition, biochemical, dietary and inflammatory parameters were recorded in all patients participating to the study, at baseline and three and six months after the start of the protocol. Body mass index (BMI) was calculated as the ratio body weight/height2 (in kg/m2) whereas bioelectrical impedance analysis (BIA) was used to evaluate body composition. Resistance and reactance were measured with a single-frequency 50 kHz bioelectrical impedance analyser, according to the standard tetrapolar technique and using the software provided by the manufacturer.

  6 months

• Inflammatory markers

  Biochemical nutritional markers included standard blood chemicals like serum albumin, urea nitrogen, glycemia and electrolytes, whereas fibrinogen, ferritin, Interleukin-6 (IL-6), and high sensitivity C Reactive Protein (hs-CRP) were assessed as markers of inflammation. IL-6 messenger ribonucleic acid (mRNA) levels were also determined in peripheral blood mononuclear cells (PBMC) at baseline and three and six months after beginning of the study.

  6 months of diet

• renal function

  Renal allograft function was evaluated by Glomerular Filtration Rate (GFR), proteinuria, and microalbuminuria; GFR was calculated by the 4-variable Modification of Diet in Renal Disease (MDRD) equation (eGFR). Urinary determinations were carried out on samples collected for 24 hours.

  6 months of diet

Study Arms (2)

Group CON

ACTIVE COMPARATOR

patients who refused to assume the n-3 rich diet and continued their usual diet

Dietary Supplement: Usual diet

Group DIET

EXPERIMENTAL

the patients assumed n-3 rich diet: Patients of the DIET group were requested to follow a diet specifically designed to increase the intake of n-3 PUFAs and to decrease the ratio n-6/n-3 by using natural foods.

Dietary Supplement: n-3 rich diet

Interventions

n-3 rich diet DIETARY_SUPPLEMENT

This dietary plan included seafood (salmon, sardines, herrings, and bluefish) and specific fruits and vegetables (oranges, strawberries, cherries, bananas, courgettes, artichokes, mushrooms, cauliflowers and pumpkins). Olive oil, rich in monounsaturated fats, was also included in the dietary plan. Patients were encouraged to use n-3 rich margarine as additional source of fatty acids. According to the data of the manufacturer, the fatty acid composition of this margarine was 3.4 mg of n-3 and 7.8 mg of n-6 per 100 g of weight. To keep n-6 PUFA intake low, patients were also requested to eat less eggs, meat, whole grains and cereals. All the components of the diet were fresh foods, with the exception of salmon and herrings that could also be preserved. Because no change in body weight was requested, patients maintained the same energy and protein intake of the diet that they assumed before entering the study.

Group DIET

Usual diet DIETARY_SUPPLEMENT

Usual diet of the patients

Group CON

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years,
• transplant vintage \>12 months,
• a preserved and stable renal function (eGFR\>20 ml/min),
• plasma urea concentration \<150 mg/dl,
• plasma albumin concentration \>3.8 g/dl,
• and a stable protein and salt intake (±15%) in the last two visits

You may not qualify if:

• malignancies,
• autoimmune diseases
• and severe infectious diseases in the last three months before the enrollment visit

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

federico II Univeristy

Naples, Naples, 80131, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 7, 2013

Record last verified: 2012-01

Locations

IT (1)