- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05725681
Satiety of High-Protein Ramen Noodles
April 18, 2025 updated by: Texas Tech University
The Role of High-Protein Instant Ramen Noodles in Inducing and Maintaining Satiety: Acute, Randomized, Crossover Study
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, investigators aim to test if intake of high-protein instant ramen noodles reduces caloric intake at the next meal compared to standard instant ramen noodles.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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, investigators aim to test if intake of high-protein instant ramen noodles reduces caloric intake at the next meal compared to standard instant ramen noodles.
Subjects meeting the eligibility criteria will be recruited and offered a 2-condition, randomized, crossover postprandial study.
Participants will be asked to limit physical activity to a specified level, consume a standardized meal at night and report to the clinic after a 12 h overnight fast.
At our clinic, in random order, participants will consume: 1) one portion of high-protein instant ramen noodles (71 g; Chef Woo, Borealis Foods); 2) an isocaloric, weight matched portion of standard instant ramen noodles.
The participants will have to finish consuming the noodles within 15 minutes.
Water will be provided at the time of breakfast and for the next two hours.
In the 4-hours following the ramen breakfast, blood will be sampled at regular intervals (0 minutes - before starting the breakfast, and 30, 60, 120 and 180 minutes after stopping breakfast) for hunger and satiety hormones (i.e., glucagon like peptide-1, peptide-YY, and ghrelin), and glucose and insulin.
Visual Analogue Scales will also be administered to assess subjective hunger and satiety.
At 4-hours, a buffet-style lunch will be provided and caloric intake at the meal will be covertly assessed.
Subjects will leave the clinic at this point.
The process will be repeated for the second condition after at least 7 d washout period.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79409
- Nutrition and Metabolic Health Initiative
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High protein ramen
Participants will be asked to limit physical activity to a specified level, consume a standardized meal at night and report to the clinic after a 12 h overnight fast.
At our clinic, for this arm, participants will consume one portion of high-protein instant ramen noodles (71 g; Chef Woo, Borealis Foods).
In the 4-hours following the ramen breakfast, blood will be sampled at regular intervals (0 minutes - before starting the breakfast, and 30, 60, 120 and 180 minutes after stopping breakfast) for hunger and satiety hormones (i.e., glucagon like peptide-1, peptide-YY, and ghrelin), and glucose and insulin.
Visual Analogue Scales will also be administered to assess subjective hunger and satiety.
At 4-hours, a buffet-style lunch will be provided and caloric intake at the meal will be covertly assessed.
|
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
Participants will be asked to limit physical activity to a specified level, consume a standardized meal at night and report to the clinic after a 12 h overnight fast.
At our clinic, for this arm, participants will consume an isocaloric, weight matched portion of standard instant ramen noodles.
In the 4-hours following the ramen breakfast, blood will be sampled at regular intervals (0 minutes - before starting the breakfast, and 30, 60, 120 and 180 minutes after stopping breakfast) for hunger and satiety hormones (i.e., glucagon like peptide-1, peptide-YY, and ghrelin), and glucose and insulin.
Visual Analogue Scales will also be administered to assess subjective hunger and satiety.
At 4-hours, a buffet-style lunch will be provided and caloric intake at the meal will be covertly assessed.
|
Participants will be served one portion of standard instant ramen noodles [RAMEN EXPRESS Chicken Flavor Ramen Cup Noodle Chef Woo, Borealis Foods; 71 g]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite Score Area Under the Curve (mm*180 minutes)
Time Frame: 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
|
0 to 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ghrelin Area Under the Curve (pg/mL*180 minutes)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Glucagon like peptide-1 (GLP-1) Area Under the Curve (pg/mL*180 minutes)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Peptide-YY (PYY) Area Under the Curve (pg/mL*180 minutes)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Glucose Area Under the Curve (mg/dL*180 minutes)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Insulin Area Under the Curve (mUI*180 minutes)
Time Frame: 0 to 180 minutes
|
Measured in serum
|
0 to 180 minutes
|
|
Perceived Hunger Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived Satiety Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived Fullness Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Prospective Food Consumption Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Minimum ghrelin (pg/mL)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Peak Glucagon like peptide-1 (GLP-1) (pg/mL)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Peak Peptide-YY (PYY) (pg/mL)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Peak Glucose (mg/dL)
Time Frame: 0 to 180 minutes
|
Measured in plasma
|
0 to 180 minutes
|
|
Peak Insulin (mUI)
Time Frame: 0 to 180 minutes
|
Measured in serum
|
0 to 180 minutes
|
|
Desire to eat something fatty Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Desire to eat something salty Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Desire to eat something savory Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Desire to eat something sweet Area Under the Curve (mm*180 minutes)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Energy intake at the buffet lunch (kcal)
Time Frame: Served approximately 3.5 hours following the ramen meal test
|
Food consumed during the buffet lunch
|
Served approximately 3.5 hours following the ramen meal test
|
|
Perceived hunger at peak GLP1 (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived satiety at peak GLP1 (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived fullness at peak GLP1 (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived hunger at peak PYY (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived satiety at peak PYY (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived fullness at peak PYY (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived hunger at minimum ghrelin (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived satiety at minimum ghrelin (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
|
Perceived fullness at minimum ghrelin (mm)
Time Frame: 0 to 180 minutes
|
Assessed by visual analogue scale.
|
0 to 180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nikhil Dhurandhar, Department of Nutritional Sciences Texas Tech University
- Principal Investigator: Kristina Petersen, Department of Nutritional Sciences Texas Tech University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
December 2, 2023
Study Completion (Actual)
December 2, 2023
Study Registration Dates
First Submitted
February 3, 2023
First Submitted That Met QC Criteria
February 3, 2023
First Posted (Actual)
February 13, 2023
Study Record Updates
Last Update Posted (Actual)
April 23, 2025
Last Update Submitted That Met QC Criteria
April 18, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 22-0729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Appetitive Behavior
-
Iowa State UniversityCompleted
-
University of LeedsCompleted
-
Arne AstrupUniversity of Copenhagen; Arla Foods; Technical University of Denmark; DuPont Nutrition...Withdrawn
-
Purdue UniversityCompletedAppetitive Behavior
-
Wilfrid Laurier UniversityNatural Sciences and Engineering Research Council, CanadaNot yet recruitingAppetitive Behavior
-
University of LeedsCompletedAppetitive BehaviorUnited Kingdom
Clinical Trials on High protein ramen
-
University of Missouri-ColumbiaRecruitingGlucose Metabolism Disorders | Metabolic Syndrome | Metabolic Syndrome, Protection AgainstUnited States
-
Purdue UniversityCompletedObesity | Dietary Modification | Lack of Satiety | Memory DeficitsUnited States
-
Wageningen UniversityTop Institute Food and NutritionCompletedIdentify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.Netherlands
-
McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR)Not yet recruitingCirrhosis | Refractory Ascites | TIPS InsertionCanada
-
Rio de Janeiro State UniversityRio de Janeiro State Research Supporting Foundation (FAPERJ)Completed
-
Erik Ramirez LopezCompletedWeight Loss | Body CompositionMexico
-
University of California, Los AngelesNational Institutes of Health (NIH)Completed
-
Purdue UniversityCompletedBlood Pressure | Cardiovascular Risk FactorUnited States
-
McMaster UniversityCompleted