- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05175391
Improving Protein Intake in Older Adults
March 8, 2023 updated by: University of Colorado, Denver
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Anschutz Health and Wellness Center Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Adults ≥ 60 years
- All body weights
- Regularly consume lunch ≥5 d/wk
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Meat based protein, no spice
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.
|
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.
|
Experimental: Meat based protein, spice added
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.
|
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.
|
Active Comparator: Plant based protein, no spice
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.
|
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.
|
Experimental: Plant based protein, spice added
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
45 minute test lunch meal on either visit one or visit two (spice or no spice in random order)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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).
|
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)
|
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".
|
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)
|
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".
|
At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John C Peters, PhD, University of Colorado Anschutz Health and Wellness Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Actual)
October 7, 2022
Study Completion (Actual)
October 7, 2022
Study Registration Dates
First Submitted
December 14, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
January 3, 2022
Study Record Updates
Last Update Posted (Estimate)
March 10, 2023
Last Update Submitted That Met QC Criteria
March 8, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-3652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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