NCT05725681

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

February 3, 2023

Last Update Submit

April 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

  • Ghrelin Area Under the Curve (pg/mL*180 minutes)

    0 to 180 minutes

  • Glucagon like peptide-1 (GLP-1) Area Under the Curve (pg/mL*180 minutes)

    0 to 180 minutes

  • Peptide-YY (PYY) Area Under the Curve (pg/mL*180 minutes)

    0 to 180 minutes

  • Glucose Area Under the Curve (mg/dL*180 minutes)

    0 to 180 minutes

  • Insulin Area Under the Curve (mUI*180 minutes)

    0 to 180 minutes

  • +23 more secondary outcomes

Study Arms (2)

High protein ramen

EXPERIMENTAL

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.

Other: High protein ramen

Standard ramen

ACTIVE COMPARATOR

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.

Other: Standard ramen

Interventions

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

High protein ramen

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

Standard ramen

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index 20-30 kg/m2

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Metabolic Health Initiative

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Nikhil Dhurandhar

    Department of Nutritional Sciences Texas Tech University

    PRINCIPAL INVESTIGATOR
  • Kristina Petersen

    Department of Nutritional Sciences Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 13, 2023

Study Start

June 1, 2023

Primary Completion

December 2, 2023

Study Completion

December 2, 2023

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations