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Chronic Obstructive Pulmonary DiseaseMINDNUTNCT04873856

Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD

A study testing Intervention in people with Chronic Obstructive Pulmonary Disease, run by Nordsjaellands Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteDenmark
Study dates
21 May 2021to 14 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Nordsjællands Hospital

    Hillerød, 3400

Other trials in Denmark

About this study

Official title: Multidimensional INDividualized NUTritional Therapy for Individuals with Severe Chronic Obstructive Pulmonary Disease

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.

Being tested
Intervention
Keywords
Chronic obstructive pulmonary disease, Health-related quality of life, Nutrition, Mental health, Functional capacity, Anthropometry
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionDietary supplement

    The four dimensions of MINDNUT are described below:

    Nutritional plan: is conducted in collaboration with the participant based on nutritional registration and information about routines and habits to reach a daily protein target of 1.5 g/kg/day. The nutritional plan is adjusted at the regular contact, and nutritional supplementation will be handed out to the participant.

    Friendly reminder/informal caregiver: is a friendly reminder that encourage the participant to follow the nutritional plan and to ask for support (a note to hang on the refrigerator). The informal caregiver is a person with close contact to the participant.

    Regular contacts: The participant will be contacted on regular basis (with an interval of 7-14 days) via phone and besides nutritional plan, this conversation will be used to talk about well-being, compliance and potential side-effects.

    Weight diary: participants is instructed in keeping a weight diary which include registration of a daily weight.

Study groups in NCT04873856
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention contains: 1. individual nutritional plan 2. regular contact 3. friendly reminder/informal caregiver and 4. weight dairy.
Receives: Dietary Supplement: Intervention
Control GroupNo interventionStandard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

    Will be measured using the EQ-5D-5L

    Measured: 1 and 3 months after baseline

Secondary outcomes (12)

  1. Weight

    Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg

    Measured: 1 and 3 months after baseline

  2. Body mass index

    Calculated as weight (kg)/height (m2)

    Measured: 1 and 3 months after baseline

  3. Hand grip strength

    Measured using handdynanometer

    Measured: 1 and 3 months after baseline

  4. Lower body strength

    Measured using 30 second stand chair test

    Measured: 1 and 3 months after baseline

  5. Number of unplanned acute hospitalizations

    Obtained from patient files

    Measured: 1 and 3 months after baseline

  6. Number of days in hospital

    Obtained from patient files

    Measured: 1 and 3 months after baseline

  7. Number of acute unplanned visits to emergency ward (<6 hours)

    Obtained from patient files

    Measured: 1 and 3 months after baseline

  8. Number of contacts to outpatient clinic (visits and phone calls)

    Obtained from patient files

    Measured: up to 3 months after baseline

  9. Disease specific quality of life

    Obtained using COPD Assessment test (CAT). CAT contains 8 items with a scoring range of 0-40. The total score indicate the impact level COPD has on the everyday life ranging from low to very high. A total score of 5 is referred to the upper limit of normal in healthy non-smokers, a total score <10 indicate low impact, 10-20 indicate medium impact, whereas >20 and >30 indicate high and very high impact, respectively.

    Measured: 1 and 3 months after baseline

  10. Mortality

    will be obtained from patient files

    Measured: up to 3 months after baseline

  11. Fat-free mass

    Measured using bioelectrical impedance analysis

    Measured: 1 and 3 months after baseline

  12. Fat mass

    Measured using bioelectrical impedance analysis

    Measured: 1 and 3 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start21 May 2021
  3. Primary completion14 Jun 2023
  4. Study completion14 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873856
Sponsor's protocol ID
MINDNUT NOH
Acronym
MINDNUT
Status last verified
Dec 2023
First submitted
23 Apr 2021
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hegelund MH, Ritz C, Olsen MF, Molgaard C, Nielsen TL, Jensen AV, Soborg C, Braagaard L, Krogh-Madsen R, Lindegaard B, Faurholt-Jepsen D. Individualized nutritional care including adherence support improves health-related quality of life in individuals with severe chronic obstructive pulmonary disease: a randomized controlled trial. Health Qual Life Outcomes. 2026 Jan 30;24(1):23. doi: 10.1186/s12955-026-02482-3.

    PubMed 41612405

  • Hegelund MH, Ritz C, Nielsen TL, Olsen MF, Soborg C, Braagaard L, Molgaard C, Krogh-Madsen R, Lindegaard B, Faurholt-Jepsen D. Multidimensional individualized nutritional therapy for individuals with severe chronic obstructive pulmonary disease: study protocol for a registry-based randomized controlled trial. Trials. 2023 Feb 6;24(1):86. doi: 10.1186/s13063-023-07099-1.

    PubMed 36747276

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Chronic Obstructive Pulmonary Disease, run by Nordsjaellands Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: 1 and 3 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04873856, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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MINDNUT Clinical Trial NCT04873856 | AzTrials