MalnutritionNiDNCT03402061
Nutrition in Disguise: Development and Palatability Testing of Novel Food Products
An observational study of Malnutrition, run by University of Waterloo at 1 site in Canada.
Trial summary
Nutrition in Disguise is focused on developing and testing the acceptability of nutrient dense food products appropriate for older adults and specifically those living in long term care. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- nutrient enhanced recipes
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2018to 30 Nov 2019
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Approximately 50 community living seniors will test each product. 15 senior residents with and 15 without dementia will be recruited as a 'taste test panel' from long germ care homes
Who may be able to join
- Older adults living in the community with no food allergies
- older adults living in long term care with and without dementia with no food allergies
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition in Disguise: Improving the Nutritional Quality of Foods for Older Adults
Nutrition in Disguise is focused on developing and testing the acceptability of nutrient dense food products appropriate for older adults and specifically those living in long term care.
Read the detailed description
Project Description: The overall goal of this research is to develop food recipes that are rich in vitamins, minerals and other food components known to support the physical and mental health of older adults. A variety of enhanced food recipes will be initially designed for older adults living in residences with applicability to pre-frail and frail older adults living in the community. It is hypothesized that the nutrient (protein and vitamins and minerals) density and anti-oxidant (i.e. phytochemical) potential of menus used in residential environments can be improved in a cost-effective manner with the inclusion of several enhanced food recipes designed for this population. This will be achieved by identifying high nutrient ingredients that can be incorporated into recipes of foods that are highly consumed by this segment. Initial work will summarize what is known from existing literature about micronutrient deficiencies and interventions with vitamins, minerals and antioxidants to improve the health of older adults. Foods commonly consumed that can be enhanced to promote their nutritional density (e.g. more nutrients in less calories) will be identified and recipes developed and tested with older adults living in the community and in residences. Products that pass this testing will then be introduced into a residence menu rotation to determine if they are well accepted by residents. A cost benefit of introducing these new products into a residence menu will be demonstrated by showing the gains in nutritional quality of the menu for the cost of producing these products in the home.
Relevance to the field of food innovation: Currently, older adults, especially those who are frail or live in residences, do not consume adequate nutrition to optimize their health. Micronutrient inadequacies are a potential problem. Research to date suggests that diet can also be supportive for delaying frailty and slowing the progression of dementia. Yet, food choices and offerings can be low in nutrition. Cost effective, innovative recipes that used common ingredients to reach nutrition goals for older adults are needed.
Anticipated outcomes:
Up to 10 enhanced recipes that have been developed for residences will be developed and tested for palatability. Knowledge tools will be created for home chefs on how to incorporate nutrient dense ingredients into recipes and how to use the information gained in this project for menu planning.
- Conditions
- Malnutrition
- Being tested
- nutrient enhanced recipes
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrient enhanced recipesDietary supplement
normal ingredients will be substituted to promote nutrient density of products
| Study group | Role | What they receive |
|---|---|---|
| Community living seniors | Approximately 50 seniors will taste test each nutrient enhanced recipe and determine acceptability and palatability. Receives: Dietary Supplement: nutrient enhanced recipes | |
| LTC cognitively well | Approximately 15 seniors living in long term care who do not have cognitive impairment will taste test each nutrient enhanced recipe and determine acceptability and palatability. Receives: Dietary Supplement: nutrient enhanced recipes | |
| LTC persons living with dementia | Approximately 15 seniors living in long term care with cognitive impairment will taste test each nutrient enhanced recipe and determine acceptability and palatability. Receives: Dietary Supplement: nutrient enhanced recipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability Scale
Participants rate the palatability of the enhanced recipe sample using a five point scale (liked very much to disliked very much) with questions on flavour, texture, appearance, overall liking and ask if the participant woudl eat this product again
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start3 Mar 2018
- Primary completion30 Jun 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- The Weston A. Price Foundation, University of Guelph
- Responsible party
- Principal investigator, Heather Keller, University of Waterloo
- Investigators
- Heather Keller, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402061
- Sponsor's protocol ID
- ORE22605
- Acronym
- NiD
- Status last verified
- Feb 2020
- First submitted
- 1 Jan 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition in Disguise: Improving the Nutritional Quality of Foods for Older Adults
- ClinicalTrials.gov ID
- NCT03402061
- Acronym / sponsor ID
- NiD / ORE22605
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- The Weston A. Price Foundation, University of Guelph
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutrition in Disguise is focused on developing and testing the acceptability of nutrient dense food products appropriate for older adults and specifically those living in long term care.
Detailed description
Project Description: The overall goal of this research is to develop food recipes that are rich in vitamins, minerals and other food components known to support the physical and mental health of older adults. A variety of enhanced food recipes will be initially designed for older adults living in residences with applicability to pre-frail and frail older adults living in the community. It is hypothesized that the nutrient (protein and vitamins and minerals) density and anti-oxidant (i.e. phytochemical) potential of menus used in residential environments can be improved in a cost-effective manner with the inclusion of several enhanced food recipes designed for this population. This will be achieved by identifying high nutrient ingredients that can be incorporated into recipes of foods that are highly consumed by this segment. Initial work will summarize what is known from existing literature about micronutrient deficiencies and interventions with vitamins, minerals and antioxidants to improve the health of older adults. Foods commonly consumed that can be enhanced to promote their nutritional density (e.g. more nutrients in less calories) will be identified and recipes developed and tested with older adults living in the community and in residences. Products that pass this testing will then be introduced into a residence menu rotation to determine if they are well accepted by residents. A cost benefit of introducing these new products into a residence menu will be demonstrated by showing the gains in nutritional quality of the menu for the cost of producing these products in the home.
Relevance to the field of food innovation: Currently, older adults, especially those who are frail or live in residences, do not consume adequate nutrition to optimize their health. Micronutrient inadequacies are a potential problem. Research to date suggests that diet can also be supportive for delaying frailty and slowing the progression of dementia. Yet, food choices and offerings can be low in nutrition. Cost effective, innovative recipes that used common ingredients to reach nutrition goals for older adults are needed.
Anticipated outcomes:
Up to 10 enhanced recipes that have been developed for residences will be developed and tested for palatability. Knowledge tools will be created for home chefs on how to incorporate nutrient dense ingredients into recipes and how to use the information gained in this project for menu planning.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community living seniors | – | Dietary Supplement: nutrient enhanced recipesApproximately 50 seniors will taste test each nutrient enhanced recipe and determine acceptability and palatability. |
| LTC cognitively well | – | Dietary Supplement: nutrient enhanced recipesApproximately 15 seniors living in long term care who do not have cognitive impairment will taste test each nutrient enhanced recipe and determine acceptability and palatability. |
| LTC persons living with dementia | – | Dietary Supplement: nutrient enhanced recipesApproximately 15 seniors living in long term care with cognitive impairment will taste test each nutrient enhanced recipe and determine acceptability and palatability. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Approximately 50 community living seniors will test each product. 15 senior residents with and 15 without dementia will be recruited as a 'taste test panel' from long germ care homes
Key inclusion criteria (2 listed)
- Older adults living in the community with no food allergies
- older adults living in long term care with and without dementia with no food allergies
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrient enhanced recipesnormal ingredients will be substituted to promote nutrient density of products | Dietary supplement | Community living seniors, LTC cognitively well, LTC persons living with dementia |
Primary outcome
Palatability Scale
Time frame: 19 months
Participants rate the palatability of the enhanced recipe sample using a five point scale (liked very much to disliked very much) with questions on flavour, texture, appearance, overall liking and ask if the participant woudl eat this product again
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Keller, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University of Waterloo at 1 site in Canada.
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 2 inclusion and 1 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 11 Feb 2020. 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 Canada. 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?
Palatability Scale (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2020.