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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03133364 |
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Date of registration:
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25/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Developing and Testing Delicious and Nutritious for the Old People
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Scientific title:
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Developing and Testing Delicious and Nutritious for the Old People |
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Date of first enrolment:
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May 17, 2017 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03133364 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Signe Loftager Okkels, Msc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Nutrition Research Unit, Gentofte University hospital. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Living at Skovhuset, nursing home in Hillerød municipality, Denmark.
- Collecting the "energy-dense diet" "ældrekost" with 40 % fat, with a main meal and a
dessert/starter.
- Able to understand and follow instructions for the procedures of the study.
- Above 65 years.
Exclusion Criteria:
- Have chewing or swallowing difficulties.
- Have acute disease or acute change in chronic disease.
- Living after special nutritional standards e.g. vegetarian, have any food allergies,
or if a participant is excluding common foods from their diet because of other
reasons.
- Not able or willing to give informed consent.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Quality of Life
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Nutritional Deficiency
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Physical Performance
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Intervention(s)
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Other: Sensory optimized meals
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Primary Outcome(s)
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Health related quality of life (EQ-5D-3L)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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MMSE (mini mental status)
[Time Frame: 12 weeks]
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Liking
[Time Frame: One month in the middle of the intervention]
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Diet registration
[Time Frame: 4 days]
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Hand grip strenght
[Time Frame: 12 weeks]
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EVS
[Time Frame: 12 weeks]
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Observations of meals
[Time Frame: One month in the middle of the intervention]
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Satisfaction with food related life (SWFL)
[Time Frame: 12 weeks]
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Chair stand
[Time Frame: 12 weeks]
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Compliance
[Time Frame: 12 weeks]
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Height
[Time Frame: 12 weeks]
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Weight
[Time Frame: 12 weeks]
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Secondary ID(s)
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H-17002835
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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