A nutrition and lifestyle intervention in patients with PuLmonary Arterial Hypertension: effect on quality of life

Nutrition and lifestyle interventions are currently not implanted in usual
clinical care of PAH-patients. Mainly because there is little known on the
relation between pathology, nutrition and lifestyle. Patients who suffer from
Pulmonary Arterial Hypertension feel insecure about their nutrition and
lifestyle. We hypothesize that an intervention on nutrition and lifestyle can
improve the patients* quality of life.

To explore the effect of a nutrition and lifestyle intervention on quality of
life for patients suffering from PuLmonary Arterial Hypertension.

Investigator initiated intervention study.

Every subject will have the option to wear a Fitbit during this study, and than
has to wear it day and night, during the entire study. With the Fitbit we want
to track the general wellbeing: daily exercise, heartrate and the sleeping
pattern. Fitbit has an secured research platform that collects data from
internet connected devices: Fitabase. This cloud-based software is fully
hosted, keeps data private and has been used in over 400 studies. The subjects
will be randomly assigned to the intervention and control group. Subsequently,
patients in the intervention group will be randomly assigned to the MedDASH
diet or MedDASHfat diet.

First, we will perform baseline measurements in the study and control group to
determine the nutritional status.

Subsequently, patients of the intervention group will receive nutritional
education. In 8 plenary masterclasses information is provided on the use of
sugar, fluid, salt, herbs, amino acids, fatty acids, vegetables, alcohol,
product labels and medication interactions with nutrition. The masterclasses,
with a duration of three hours for every session, will be given in small groups
(maximum of ten per group) and the patients will receive homework with
nutrition and lifestyle assignments. Two weeks after the last masterclass the
whole study group will participate in a cooking masterclass on location, to
implement the obtained knowledge.

After the nutritional education, the subjects of the intervention group will be
randomly assigned to a MedDASH diet or a MedDASHfat diet. The MedDASH diet is
comprised of 55% carbohydrates, 25% amino acids, 20% fatty acids, whereas the
MedDASHfat diet is comprised of 10% carbohydrates, 25% amino acids, 65% fatty
acids. Both groups will receive a list of products they can consume daily,
daily menu examples and precepts for the diet and lifestyle (for example: only
eat carbohydrates once a day, don*t use blue light after 10 p.m., make a list
before you go grocery shopping). After 3 months of diet, efficacy is tested by
comparing quality of life, RV function, exercise capacity and general
well-being between the 2 diets and the control group. After 6 months,
compliance is analysed.

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. The radiation risk form the DEXAscan is minimal, with 0,05 mSV in
the total study There is a minimum risk in participation.