Multidimensional Individualized Nutritional Therapy for Individuals With Severe COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— MINDNUT  

Official title:

Multidimensional INDividualized NUTritional Therapy for Individuals With Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873856
• Other study ID #: MINDNUT NOH
• Status: Completed
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: June 14, 2023

Study information

• Verified date: December 2023
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Intervention
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.

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød

Sponsors (3)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Rigshospitalet, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total protein intake	Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams	1 and 3 months after baseline
Other	Difference in protein requirement and protein intake	Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams adnd requirements is calculated as 1.5 g/kg/day.	1 and 3 months after baseline
Other	Total energy intake	Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories.	1 and 3 months after baseline
Other	Difference in energy requirement and energy intake	Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories. Requirements calculated as 30 kcal/kg/day if goal is weight maintenance and 45 kcal kg/day if goal is weight gain	1 and 3 months after baseline
Other	Upper arm circumference	Measured using a measuring tape to the nearest 0.1 cm	1 and 3 months after baseline
Other	Hip circumference	Measured using a measuring tape to the nearest 0.1 cm	1 and 3 months after baseline
Other	Waist circumference	Measured using a measuring tape to the nearest 0.1 cm	1 and 3 months after baseline
Other	Number of exacerbations	Obtained from patient files supplemented with self-reported information	1 and 3 months after baseline
Other	Oxygen therapy	Self-reported. The participant is asked if he/she is currently using home oxygen.	1 and 3 months after baseline
Other	Anxiety and depression	Measured using Hospital Anxiety and Depression Scale. The scale contains two subscales to evaluate risk of anxiety and depression. Each subscale contains 7 items with a total score from 0-21. Risk of anxiety and depression are based on a total score =8.	1 and 3 months
Other	Physical activity (subjective)	Measured using the physical activity and vial signs questionnaire	1 and 3 months after baseline
Other	Physical activity (objective)	Measured using accelerometers (Activity AX3, Newcastle, United Kingdom)	7 days from 1- months follow-up and 7 days from 3 months follow-up
Primary	Health-related quality of life	Will be measured using the EQ-5D-5L	1 and 3 months after baseline
Secondary	Weight	Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg	1 and 3 months after baseline
Secondary	Body mass index	Calculated as weight (kg)/height (m2)	1 and 3 months after baseline
Secondary	Hand grip strength	Measured using handdynanometer	1 and 3 months after baseline
Secondary	Lower body strength	Measured using 30 second stand chair test	1 and 3 months after baseline
Secondary	Number of unplanned acute hospitalizations	Obtained from patient files	1 and 3 months after baseline
Secondary	Number of days in hospital	Obtained from patient files	1 and 3 months after baseline
Secondary	Number of acute unplanned visits to emergency ward (<6 hours)	Obtained from patient files	1 and 3 months after baseline
Secondary	Number of contacts to outpatient clinic (visits and phone calls)	Obtained from patient files	up to 3 months after baseline
Secondary	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.	1 and 3 months after baseline
Secondary	Mortality	will be obtained from patient files	up to 3 months after baseline
Secondary	Fat-free mass	Measured using bioelectrical impedance analysis	1 and 3 months after baseline
Secondary	Fat mass	Measured using bioelectrical impedance analysis	1 and 3 months after baseline