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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05175391
Other study ID # 21-3652
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2022
Est. completion date October 7, 2022

Study information

Verified date March 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

There are two specific aims: 1. 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). 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 7, 2022
Est. primary completion date October 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Meat based protein with added spice; Plant based protein with added spice
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.

Locations

Country Name City State
United States Anschutz Health and Wellness Center Anschutz Medical Campus Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver McCormick Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 45 minute test lunch meal on either visit one or visit two (spice or no spice in random order)
Secondary 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). At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Secondary 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". At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
Secondary 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". At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)
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