Satiety of High-protein Ramen Noodles

Study Overview
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Brief Summary
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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.

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

Conditions
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Appetitive Behavior

Intervention / Treatment
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* Other: High protein ramen
* Other: Standard ramen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein ramen<br> | Other: High protein ramen<br>* Participants will be served one portion of high-protein instant ramen noodles [CHEF WOO Roasted Chicken Flavor Ramen Cup Noodles, Borealis Foods; 71 g]<br>|
| Active Comparator: Standard ramen<br> | Other: Standard ramen<br>* Participants will be served one portion of standard instant ramen noodles [RAMEN EXPRESS Chicken Flavor Ramen Cup Noodle Chef Woo, Borealis Foods; 71 g]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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