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

N

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

87 participants in 2 patient groups

Intervention group
Experimental group
Description:
Intervention contains: 1. individual nutritional plan 2. regular contact 3. friendly reminder/informal caregiver and 4. weight dairy.
Treatment:
Dietary Supplement: Intervention
Control Group
No Intervention group
Description:
Standard of care

Trial contacts and locations

1

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Central trial contact

Maria H Hegelund

Data sourced from clinicaltrials.gov

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