Clinical trial NCT05725681: Satiety of High-Protein Ramen Noodles
Official title: The Role of High-Protein Instant Ramen Noodles in Inducing and Maintaining Satiety: Acute, Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Appetite Score Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
Secondary outcomes:
measure: Ghrelin Area Under the Curve (pg/mL*180 minutes)
timeFrame: 0 to 180 minutes
measure: Glucagon like peptide-1 (GLP-1) Area Under the Curve (pg/mL*180 minutes)
timeFrame: 0 to 180 minutes
measure: Peptide-YY (PYY) Area Under the Curve (pg/mL*180 minutes)
timeFrame: 0 to 180 minutes
measure: Glucose Area Under the Curve (mg/dL*180 minutes)
timeFrame: 0 to 180 minutes
measure: Insulin Area Under the Curve (mUI*180 minutes)
timeFrame: 0 to 180 minutes
measure: Perceived Hunger Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Perceived Satiety Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Perceived Fullness Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Prospective Food Consumption Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Minimum ghrelin (pg/mL)
timeFrame: 0 to 180 minutes
measure: Peak Glucagon like peptide-1 (GLP-1) (pg/mL)
timeFrame: 0 to 180 minutes
measure: Peak Peptide-YY (PYY) (pg/mL)
timeFrame: 0 to 180 minutes
measure: Peak Glucose (mg/dL)
timeFrame: 0 to 180 minutes
measure: Peak Insulin (mUI)
timeFrame: 0 to 180 minutes
measure: Desire to eat something fatty Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Desire to eat something salty Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Desire to eat something savory Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Desire to eat something sweet Area Under the Curve (mm*180 minutes)
timeFrame: 0 to 180 minutes
measure: Energy intake at the buffet lunch (kcal)
timeFrame: Served approximately 3.5 hours following the ramen meal test
measure: Perceived hunger at peak GLP1 (mm)
timeFrame: 0 to 180 minutes
measure: Perceived satiety at peak GLP1 (mm)
timeFrame: 0 to 180 minutes
measure: Perceived fullness at peak GLP1 (mm)
timeFrame: 0 to 180 minutes
measure: Perceived hunger at peak PYY (mm)
timeFrame: 0 to 180 minutes
measure: Perceived satiety at peak PYY (mm)
timeFrame: 0 to 180 minutes
measure: Perceived fullness at peak PYY (mm)
timeFrame: 0 to 180 minutes
measure: Perceived hunger at minimum ghrelin (mm)
timeFrame: 0 to 180 minutes
measure: Perceived satiety at minimum ghrelin (mm)
timeFrame: 0 to 180 minutes
measure: Perceived fullness at minimum ghrelin (mm)
timeFrame: 0 to 180 minutes
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Nutrition and Metabolic Health Initiative
state: Texas
Study officials:
affiliation: Department of Nutritional Sciences Texas Tech University
name: Nikhil Dhurandhar
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutritional Sciences Texas Tech University
name: Kristina Petersen
role: PRINCIPAL_INVESTIGATOR
References: