A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
NCT ID: NCT05318950
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-10-20
2022-02-16
Brief Summary
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Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH.
Study design: Investigator initiated intervention study with control group. Study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related PAH, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes.
Intervention (if applicable): Nutritional status, - education, - intervention and - compliance.
Main study parameters/endpoints: This is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by SF-36 overall outcome with a significant difference of 6.35.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is minimal risk in participation.
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Detailed Description
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Nutritional education:
8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants recieve workbook with assignments.
Nutritional intervention:
Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet.
Follow-up:
Patients in intervention arm followed for a period of 6 months to assess compliance.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Control
No intervention
No interventions assigned to this group
E-learning
E-learning: 8 lessons about nutrition and lifestyle
E-learning
8 lessons about nutrition and lifestyle
Diet A
MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids)
E-learning
8 lessons about nutrition and lifestyle
Diet
Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
Diet B
MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
E-learning
8 lessons about nutrition and lifestyle
Diet
Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
Interventions
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E-learning
8 lessons about nutrition and lifestyle
Diet
Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 80
* NYHA II or III and stable for at least 3 months, determined by a stable 6minute walk test with a difference of \<10%.
* Self-sufficient and/or compliance from partner and/or family
* Creatinine \> 30 ml/min
* Able to understand and willing to sign the Informed Consent Form
Exclusion Criteria
* Fat percentage \< 10% \> 50 %
* One or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease
* Known history of noncompliance considering therapies
18 Years
80 Years
ALL
No
Sponsors
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Reinier de Graaf Groep
OTHER
Janssen-Cilag B.V.
INDUSTRY
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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A. Vonk Noordegraaf
Prof. Dr.
Principal Investigators
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Anton Vonk Noordegraaf, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
VUMC
Locations
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VU medical center
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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NL66484.029.18
Identifier Type: -
Identifier Source: org_study_id
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