Satiety of High-protein Ramen Noodles

Appetitive Behavior Clinical Trial

Official title:

The Role of High-Protein Instant Ramen Noodles in Inducing and Maintaining Satiety: Acute, Randomized, Crossover Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05725681
• Other study ID #: 22-0729
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Appetitive Behavior

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