Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD (MINDNUT)

Nordsjaellands Hospital

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Dietary Supplement: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04873856

MINDNUT NOH

Details and patient eligibility

About

Individuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. Nutritional risk and low quality of life are common, and both associated with increased societal cost and poor prognosis. COPD is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. The primary aim is to improve quality of life for individuals with severe COPD.

120 individuals are recruited from the outpatient clinic at Nordsjællands Hospital in Denmark to a randomized controlled trial with two parallel groups (intervention and control). The intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy.

We expect that the intervention will improve quality of life, nutritional status and prognosis.

Enrollment

87 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 35 years
Severe COPD defined as GOLD grade 2 group B or D OR GOLD grade 3 and 4 group ABCD
Able to eat orally
Live in own home
Speak Danish or English
Undernourished OR at risk of undernutrition defined as BMI ≤ 21 kg/m2 if < 70 years and BMI <22 kg/m2 if ≥70 years OR BMI 21-25 kg/m2 plus nutritional risk (nutritional risk screening score ≥3) if <70 years and BMI 22-25 kg/m2 plus nutritional risk if ≥70 years
Stable phase

CHANGE: Undernourished OR at risk of undernutrition (a maximum BMI of 25 kg/m2) determined by Nutritional Risk Screening 2002 or Mini Nutritional Assessment Short Form according to the protocol published in Trials.

Exclusion criteria

Active solid cancer" defined as cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months or hematological cancer that is not in complete remission
Unable to sign informed consent e.g. due to severe dementia.
Severe chronic renal failure defined as estimated glomerular filtration rate < 30 mL/min./1.73 m2 (ICD-10 codes N18.4 and N18.5
Severe alcohol abuse (ICD-10 codes F10.2 and K70.x).