Satiety of High-protein Ramen Noodles

Sponsor
Texas Tech University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05725681
Collaborator
(none)
20
2
10

Study Details

Study Description

Brief Summary

The aim of this study is to determine if high-protein instant ramen noodles acutely increase satiety, reduce hunger, and improve blood sugar levels compared to standard instant ramen noodles in generally healthy young to middle aged adults. In addition, we aim to test if intake of high-protein instant ramen noodles reduces caloric intake at the next meal compared to standard instant ramen noodles.

Condition or Disease Intervention/Treatment Phase
  • Other: High protein ramen
  • Other: Standard ramen
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Role of High-Protein Instant Ramen Noodles in Inducing and Maintaining Satiety: Acute, Randomized, Crossover Study
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: High protein ramen

Other: High protein ramen
Participants will be served one portion of high-protein instant ramen noodles [CHEF WOO Roasted Chicken Flavor Ramen Cup Noodles, Borealis Foods; 71 g]

Active Comparator: Standard ramen

Other: Standard ramen
Participants will be served one portion of standard instant ramen noodles [RAMEN EXPRESS Chicken Flavor Ramen Cup Noodle Chef Woo, Borealis Foods; 71 g]

Outcome Measures

Primary Outcome Measures

  1. Appetite Score Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Calculated as satiety + fullness + (100 - hunger) + (100 - prospective food consumption)/4. Questions 1-4 from the Visual Analogue Scale will be used to assess satiety, fullness, hunger and prospective food consumption and calculate the Appetite Score

Secondary Outcome Measures

  1. Ghrelin Area Under the Curve (pg/mL*180 minutes) [0 to 180 minutes]

    Measured in plasma

  2. Glucagon like peptide-1 (GLP-1) Area Under the Curve (pg/mL*180 minutes) [0 to 180 minutes]

    Measured in plasma

  3. Peptide-YY (PYY) Area Under the Curve (pg/mL*180 minutes) [0 to 180 minutes]

    Measured in plasma

  4. Glucose Area Under the Curve (mg/dL*180 minutes) [0 to 180 minutes]

    Measured in plasma

  5. Insulin Area Under the Curve (mUI*180 minutes) [0 to 180 minutes]

    Measured in serum

  6. Perceived Hunger Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  7. Perceived Satiety Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  8. Perceived Fullness Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  9. Prospective Food Consumption Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  10. Minimum ghrelin (pg/mL) [0 to 180 minutes]

    Measured in plasma

  11. Peak Glucagon like peptide-1 (GLP-1) (pg/mL) [0 to 180 minutes]

    Measured in plasma

  12. Peak Peptide-YY (PYY) (pg/mL) [0 to 180 minutes]

    Measured in plasma

  13. Peak Glucose (mg/dL) [0 to 180 minutes]

    Measured in plasma

  14. Peak Insulin (mUI) [0 to 180 minutes]

    Measured in serum

  15. Desire to eat something fatty Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  16. Desire to eat something salty Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  17. Desire to eat something savory Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  18. Desire to eat something sweet Area Under the Curve (mm*180 minutes) [0 to 180 minutes]

    Assessed by visual analogue scale.

  19. Energy intake at the buffet lunch (kcal) [Served approximately 3.5 hours following the ramen meal test]

    Food consumed during the buffet lunch

  20. Perceived hunger at peak GLP1 (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  21. Perceived satiety at peak GLP1 (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  22. Perceived fullness at peak GLP1 (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  23. Perceived hunger at peak PYY (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  24. Perceived satiety at peak PYY (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  25. Perceived fullness at peak PYY (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  26. Perceived hunger at minimum ghrelin (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  27. Perceived satiety at minimum ghrelin (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

  28. Perceived fullness at minimum ghrelin (mm) [0 to 180 minutes]

    Assessed by visual analogue scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Body Mass Index 20-30 kg/m2
Exclusion Criteria:
  • Unwilling or unable to have an IV catheter inserted

  • Body weight <110 pounds

  • Diabetes (any type)

  • Fasting capillary glucose ≥100 mg/dL

  • Unstable systemic medical condition

•>10% change in body weight in the prior 3 months

  • Medications that affect appetite or glucose regulation

  • Prior bariatric surgery

  • Uncontrolled hypertension (i.e., unmedicated blood pressure >130/90 mmHg)

  • Intolerance, dislike or allergy to the study food

  • Current or recent (within 6 months) tobacco use

  • High alcohol consumption (>14 drinks/week)

  • Currently following a weight loss diet

  • Irregular menstrual cycle

  • Currently pregnant or lactating

  • Principal investigator discretion (e.g., disrespectful or inappropriate interactions with study staff

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Texas Tech University

Investigators

  • Principal Investigator: Nikhil Dhurandhar, Department of Nutritional Sciences Texas Tech University
  • Principal Investigator: Kristina Petersen, Department of Nutritional Sciences Texas Tech University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Texas Tech University
ClinicalTrials.gov Identifier:
NCT05725681
Other Study ID Numbers:
  • 22-0729
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 13, 2023