Food PreferencesNCT05175391
Improving Protein Intake in Older Adults
A study testing Meat based protein with added spice; Plant based protein with added spice in people with Food Preferences, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To evaluate whether or not high quality protein intake from a mixed meal can be increased by using culinary herbs and spices to increase flavor intensity and food item liking in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Preferences
- What is being tested?
- Meat based protein with added spice; Plant based protein with added spice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 7 Oct 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 60 years
- All body weights
- Regularly consume lunch ≥5 d/wk
Who cannot join
- Diagnosed taste or sensory disorders that would prevent evaluating the food
- Known eating disorders
- Allergies to the test food/ingredients (including herbs and spices)
- Medications or medical conditions that may adversely affect taste (e.g., dysgeusia)
- Inability to complete the protocol
- Dietary restrictions re. test meal items/ingredients (e.g., prescribed low salt diet)
- Dislike of the particular food items or herb/spices to be served in the test meals
Trial locations and contacts
1 site in 1 country.
United States1 site
Anschutz Health and Wellness Center Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Improving the Liking and Consumption of Protein Rich Foods in Older Adults Through the Use of Culinary Spices
To evaluate whether or not high quality protein intake from a mixed meal can be increased by using culinary herbs and spices to increase flavor intensity and food item liking in older adults.
Read the detailed description
There are two specific aims:
- To assess whether healthy older adults ≥60 years are able to consume 1.2g/kg/BW of high quality protein (the suggested requirement for older adults) in a single meal (lunch, accounting for approximately 30% of total daily energy intake).
- To assess whether protein intake at a single meal is increased by enhancing the flavor intensity and perceived liking of the protein rich food using culinary herbs and spices.
The hypothesis is that it is feasible to meet the suggested increased protein requirement for older adults of 1.2 g/kg/BW (Baum et al.) (at 30% of daily energy/meal) in a single meal and that addition of culinary spices results in greater perceived flavor intensity and liking and greater intake compared to a meal prepared with only salt and pepper.
- Conditions
- Food Preferences
- Being tested
- Meat based protein with added spice; Plant based protein with added spice
- Keywords
- taste test, spices, food liking, protein
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meat based protein with added spice; Plant based protein with added spiceOther
Either meat or plant based protein entrees will have herbs and spices added (in addition to salt and pepper in the base recipe) to intensify the flavor profile in order to see if protein consumption is affected.
| Study group | Role | What they receive |
|---|---|---|
| Meat based protein, no spice | Active comparator | Test meal will be a chicken salad entree consisting of shredded skinless chicken breast, mayonnaise, lemon juice, celery, salt and pepper, with whole wheat crackers and grapes as side items. Receives: Other: Meat based protein with added spice; Plant based protein with added spice |
| Meat based protein, spice added | Experimental | Test meal will be a chicken salad entree consisting of shredded skinless chicken breast, mayonnaise, lemon juice, celery, salt and pepper, onion powder, garlic powder, dill and ground mustard seed, served with whole wheat crackers and grapes as side items. Receives: Other: Meat based protein with added spice; Plant based protein with added spice |
| Plant based protein, no spice | Active comparator | Test meal will be a chick pea and rice salad entree consisting of chick peas, brown rice, mayonnaise, yogurt, lemon juice, celery, soy protein powder, salt and pepper, served with whole wheat crackers and grapes as side items. Receives: Other: Meat based protein with added spice; Plant based protein with added spice |
| Plant based protein, spice added | Experimental | Test meal will be a chick pea and rice salad entree consisting of chick peas, brown rice, mayonnaise, yogurt, lemon juice, celery, soy protein powder, salt and pepper, onion powder, garlic powder, cumin, parsley, dill, oregano, ground rosemary and ground mustard seed, served with whole wheat crackers and grapes as side items. Receives: Other: Meat based protein with added spice; Plant based protein with added spice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein consumption at lunch test meal
Grams of protein consumed per kg body weight at lunch test meal. Grams of protein consumption will be determined from the amount of each food item consumed multiplied by the protein density (g protein per gram food item) of each item. Amount consumed will be determined by subtracting the weight of any food item not consumed from the weight of each food item provided. Protein density will be determined by calculating the grams of protein 100 grams of food item using ingredient information for the entree and the U. Minnesota Nutrition Data System (NDS) tables for protein content of ingredients, NDS tables for grapes and using manufacturer's information for the whole wheat crackers. Body weights will be measured at the beginning of visit one to the testing center using a calibrated body weight scale.
Measured: 45 minute test lunch meal on either visit one or visit two (spice or no spice in random order)
Secondary outcomes (3)
Subjective liking of protein entree and entire meal
Participants will fill out a two item check list using a 9-point hedonic scale rating the liking of the entree item and of the entire meal The scale is a 9-point likert scale with scores ranging from 1 - 9 to assess liking (where the lowest rating of 1 indicated extreme disliking and the highest rating of 9 indicated extreme liking).
Measured: At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Subjective appetite ratings following lunch test meal
Participants will complete a four item visual analog scale (VAS) asking about hunger, fullness, desire to eat and prospective consumption. Each item will consist of a 100mm horizontal scale anchored at each end by "not at all hungry" and "extremely hungry"; "not at all full" and "extremely full"; "no desire to eat" and "extreme desire to eat"; and "not much at all" and "an extreme amount".
Measured: At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Subjective rating of flavor intensity of lunch entree and overall meal
Participants will complete a two item check list using a 5 point Likert scale rating the flavor intensity of the entree and overall meal. The scale will be anchored at one end by "no intensity at all" and at the other by "extremely intense".
Measured: At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start9 May 2022
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food PreferencesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To determine the consumption, liking, flavor intensity and subjective appetite ratings of two different lunch meal treatments in two separate participant groups fed different protein rich meals: 1. Meat-derived protein meal, and 2. Plant-derived protein meal using a randomized, two-period, within participants, crossover design. The two test conditions for each protein meal type will be (1) salt and pepper only preparation (No Spice, NS), and (2) herb and spice preparation (Spice, S). Within each protein meal type, the two test meals will be matched for macronutrients and calories. Each participant will consume either the meat meal or the vegetarian meal at both of their two testing days that will be at least one week apart. Each participant will be randomized into a meal type sequence group so that the order of consuming the No Spice or Spice meals will be randomized.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Sponsor
- Investigators
- John C Peters, PhD, Principal investigator, University of Colorado Anschutz Health and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175391
- Sponsor's protocol ID
- 21-3652
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baum JI, Kim IY, Wolfe RR. Protein Consumption and the Elderly: What Is the Optimal Level of Intake? Nutrients. 2016 Jun 8;8(6):359. doi: 10.3390/nu8060359.
PubMed 27338461
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Liking and Consumption of Protein Rich Foods in Older Adults Through the Use of Culinary Spices
- ClinicalTrials.gov ID
- NCT05175391
- Acronym / sponsor ID
- 21-3652
- Conditions
- Food Preferences
- Keywords
- taste test, spices, food liking, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- 9 May 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 3 Jan 2022 (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.
To evaluate whether or not high quality protein intake from a mixed meal can be increased by using culinary herbs and spices to increase flavor intensity and food item liking in older adults.
Detailed description
There are two specific aims:
- To assess whether healthy older adults ≥60 years are able to consume 1.2g/kg/BW of high quality protein (the suggested requirement for older adults) in a single meal (lunch, accounting for approximately 30% of total daily energy intake).
- To assess whether protein intake at a single meal is increased by enhancing the flavor intensity and perceived liking of the protein rich food using culinary herbs and spices.
The hypothesis is that it is feasible to meet the suggested increased protein requirement for older adults of 1.2 g/kg/BW (Baum et al.) (at 30% of daily energy/meal) in a single meal and that addition of culinary spices results in greater perceived flavor intensity and liking and greater intake compared to a meal prepared with only salt and pepper.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- To determine the consumption, liking, flavor intensity and subjective appetite ratings of two different lunch meal treatments in two separate participant groups fed different protein rich meals: 1. Meat-derived protein meal, and 2. Plant-derived protein meal using a randomized, two-period, within participants, crossover design. The two test conditions for each protein meal type will be (1) salt and pepper only preparation (No Spice, NS), and (2) herb and spice preparation (Spice, S). Within each protein meal type, the two test meals will be matched for macronutrients and calories. Each participant will consume either the meat meal or the vegetarian meal at both of their two testing days that will be at least one week apart. Each participant will be randomized into a meal type sequence group so that the order of consuming the No Spice or Spice meals will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Meat based protein, no spice | Active comparator | Other: Meat based protein with added spice; Plant based protein with added spiceTest meal will be a chicken salad entree consisting of shredded skinless chicken breast, mayonnaise, lemon juice, celery, salt and pepper, with whole wheat crackers and grapes as side items. |
| Meat based protein, spice added | Experimental | Other: Meat based protein with added spice; Plant based protein with added spiceTest meal will be a chicken salad entree consisting of shredded skinless chicken breast, mayonnaise, lemon juice, celery, salt and pepper, onion powder, garlic powder, dill and ground mustard seed, served with whole wheat crackers and grapes as side items. |
| Plant based protein, no spice | Active comparator | Other: Meat based protein with added spice; Plant based protein with added spiceTest meal will be a chick pea and rice salad entree consisting of chick peas, brown rice, mayonnaise, yogurt, lemon juice, celery, soy protein powder, salt and pepper, served with whole wheat crackers and grapes as side items. |
| Plant based protein, spice added | Experimental | Other: Meat based protein with added spice; Plant based protein with added spiceTest meal will be a chick pea and rice salad entree consisting of chick peas, brown rice, mayonnaise, yogurt, lemon juice, celery, soy protein powder, salt and pepper, onion powder, garlic powder, cumin, parsley, dill, oregano, ground rosemary and ground mustard seed, served with whole wheat crackers and grapes as side items. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 60 years
- All body weights
- Regularly consume lunch ≥5 d/wk
Key exclusion criteria (7 listed)
- Diagnosed taste or sensory disorders that would prevent evaluating the food
- Known eating disorders
- Allergies to the test food/ingredients (including herbs and spices)
- Medications or medical conditions that may adversely affect taste (e.g., dysgeusia)
- Inability to complete the protocol
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 |
|---|---|---|
| Meat based protein with added spice; Plant based protein with added spiceEither meat or plant based protein entrees will have herbs and spices added (in addition to salt and pepper in the base recipe) to intensify the flavor profile in order to see if protein consumption is affected. | Other | Meat based protein, no spice, Meat based protein, spice added, Plant based protein, no spice, Plant based protein, spice added |
Primary outcome
Protein consumption at lunch test meal
Time frame: 45 minute test lunch meal on either visit one or visit two (spice or no spice in random order)
Grams of protein consumed per kg body weight at lunch test meal. Grams of protein consumption will be determined from the amount of each food item consumed multiplied by the protein density (g protein per gram food item) of each item. Amount consumed will be determined by subtracting the weight of any food item not consumed from the weight of each food item provided. Protein density will be determined by calculating the grams of protein 100 grams of food item using ingredient information for the entree and the U. Minnesota Nutrition Data System (NDS) tables for protein content of ingredients, NDS tables for grapes and using manufacturer's information for the whole wheat crackers. Body weights will be measured at the beginning of visit one to the testing center using a calibrated body weight scale.
3 secondary outcomes
Subjective liking of protein entree and entire meal
Time frame: At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Subjective appetite ratings following lunch test meal
Time frame: At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Subjective rating of flavor intensity of lunch entree and overall meal
Time frame: At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
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 10 Mar 2023.
- Background: PubMed 27338461Baum JI, Kim IY, Wolfe RR. Protein Consumption and the Elderly: What Is the Optimal Level of Intake? Nutrients. 2016 Jun 8;8(6):359. doi: 10.3390/nu8060359.
- 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.
John C Peters, PhD principal investigator
University of Colorado Anschutz Health and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meat based protein with added spice; Plant based protein with added spice in people with Food Preferences, run by University of Colorado, Denver at 1 site in United States.
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 3 inclusion and 7 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 10 Mar 2023. 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 United States. 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?
Protein consumption at lunch test meal (time frame: 45 minute test lunch meal on either visit one or visit two (spice or no spice in random order)). 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 NCT05175391, which also lists 1 linked publication.
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 10 Mar 2023.