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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05725681
Other study ID # 22-0729
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Texas Tech University
Contact Kristina Petersen
Phone 18068342164
Email kristina.petersen@ttu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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]
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]

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University

Outcome

Type Measure Description Time frame Safety issue
Primary Appetite Score Area Under the Curve (mm*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 0 to 180 minutes
Secondary Ghrelin Area Under the Curve (pg/mL*180 minutes) Measured in plasma 0 to 180 minutes
Secondary Glucagon like peptide-1 (GLP-1) Area Under the Curve (pg/mL*180 minutes) Measured in plasma 0 to 180 minutes
Secondary Peptide-YY (PYY) Area Under the Curve (pg/mL*180 minutes) Measured in plasma 0 to 180 minutes
Secondary Glucose Area Under the Curve (mg/dL*180 minutes) Measured in plasma 0 to 180 minutes
Secondary Insulin Area Under the Curve (mUI*180 minutes) Measured in serum 0 to 180 minutes
Secondary Perceived Hunger Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived Satiety Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived Fullness Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Prospective Food Consumption Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Minimum ghrelin (pg/mL) Measured in plasma 0 to 180 minutes
Secondary Peak Glucagon like peptide-1 (GLP-1) (pg/mL) Measured in plasma 0 to 180 minutes
Secondary Peak Peptide-YY (PYY) (pg/mL) Measured in plasma 0 to 180 minutes
Secondary Peak Glucose (mg/dL) Measured in plasma 0 to 180 minutes
Secondary Peak Insulin (mUI) Measured in serum 0 to 180 minutes
Secondary Desire to eat something fatty Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Desire to eat something salty Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Desire to eat something savory Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Desire to eat something sweet Area Under the Curve (mm*180 minutes) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Energy intake at the buffet lunch (kcal) Food consumed during the buffet lunch Served approximately 3.5 hours following the ramen meal test
Secondary Perceived hunger at peak GLP1 (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived satiety at peak GLP1 (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived fullness at peak GLP1 (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived hunger at peak PYY (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived satiety at peak PYY (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived fullness at peak PYY (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived hunger at minimum ghrelin (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived satiety at minimum ghrelin (mm) Assessed by visual analogue scale. 0 to 180 minutes
Secondary Perceived fullness at minimum ghrelin (mm) Assessed by visual analogue scale. 0 to 180 minutes
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