NCT06472011

Brief Summary

The objectives of this study are to assess the impacts of meals composed of lean steak and potatoes (with a small portion of broccoli) in comparison to other common entrée/starch food combinations on metabolic and appetite responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

June 18, 2024

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • appetite response

    Using 100 mm visual analog scales (score from 0 to 100 and higher score means more)

    baseline (B), 15 minutes from B, 30 minutes from B, 45 minutes from B, 60 minutes from B, 90 minutes from B, 120 minutes from B, 150 minutes from B, 180 minutes from B, 210 minutes from B, 240 minutes from B

Secondary Outcomes (1)

  • blood glucose

    baseline (B), 15 minutes from B, 30 minutes from B, 45 minutes from B, 60 minutes from B, 90 minutes from B, 120 minutes from B, 150 minutes from B, 180 minutes from B, 210 minutes from B, 240 minutes from B

Study Arms (7)

Arm 1 (lean steak and potatoes)

EXPERIMENTAL

lean steak and potatoes will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: lean steak and potatoes

Arm 2 (lentil and sweet potato chili )

EXPERIMENTAL

lentil and sweet potato chili will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: lentil and sweet potato chili

Arm 3 (macaroni and cheese)

EXPERIMENTAL

macaroni and cheese will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: macaroni and cheese

Arm 4 (fish tacos)

EXPERIMENTAL

fish tacos will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: fish tacos

Arm 5 (chicken and pea fried rice)

EXPERIMENTAL

chicken and pea fried rice will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: chicken and pea fried rice

Arm 6 (pita and hummus)

EXPERIMENTAL

pita and hummus will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: pita and hummus

Arm 7 (creamy pork pasta)

EXPERIMENTAL

creamy pork pasta will be provided to subjects and primary and secondary outcomes will be measured at timelines explained under primary and secondary outcome measures.

Other: creamy pork pasta

Interventions

Participants will be fed \~400 kcal lean steak and potatoes on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 1 (lean steak and potatoes)

Participants will be fed \~400 kcal lentil and sweet potato chili on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 2 (lentil and sweet potato chili )

Participants will be fed \~400 kcal macaroni and cheese on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 3 (macaroni and cheese)

Participants will be fed \~400 kcal fish tacos on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 4 (fish tacos)

Participants will be fed \~400 kcal chicken and pea fried rice on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 5 (chicken and pea fried rice)

Participants will be fed \~400 kcal pita and hummus on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 6 (pita and hummus)

Participants will be fed \~400 kcal creamy pork pasta on one occasion to test for changes in blood glucose and insulin levels as well as appetite over a 4-hour period of time.

Arm 7 (creamy pork pasta)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages of 18-50 years
  • BMI between 18-26

You may not qualify if:

  • special dietary needs (e.g., gluten-free, etc.),
  • % weight change in the previous 2 months,
  • smoking, and substance use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182-7251, United States

Location

MeSH Terms

Interventions

Cheese

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 7 crossover arms for each subject
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

August 7, 2024

Primary Completion

March 22, 2025

Study Completion

March 22, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations