NCT05175391

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

December 14, 2021

Last Update Submit

March 8, 2023

Conditions

Keywords

taste testspicesfood likingprotein

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Subjective liking of protein entree and entire meal

    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

    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

    At completion of 45 minute lunch test meal on visits one and two (spice or no spice in randomized order)

Study Arms (4)

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.

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.

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.

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.

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

Interventions

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.

Meat based protein, no spiceMeat based protein, spice addedPlant based protein, no spicePlant based protein, spice added

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 60 years
  • All body weights
  • Regularly consume lunch ≥5 d/wk

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anschutz Health and Wellness Center Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related 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.

    PMID: 27338461BACKGROUND

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • John C Peters, PhD

    University of Colorado Anschutz Health and Wellness Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Test meal items will be identical except for the addition of culinary spices. Meals will be prepared by Nutrition Core Laboratory staff who have no contact with participants. Meals will be coded and given to study staff to serve to participants. Entree appearance may differ due to presence of culinary herbs (green specks) and may have different aroma. However, the PI will not be present during meal testing and thus will be masked.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

May 9, 2022

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations