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CompletedNCT01145963SATUpdated Jul 27, 2021

Pasta Formulations and Their Effect on Appetite

An interventional study of Control pasta and Experimental pasta B in Appetite, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Investigators are interested in learning how appetite responds to pasta containing different amounts of protein and fiber. In this research study, subjects will be asked to eat as much as they want of pasta containing different amounts of protein and fiber mixtures, thereafter subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours afterwards. Subjects will be asked to do this on three separate occasions.

Read the detailed description

The study is a randomized, 3-arm, treatment-controlled, within-subjects, 3-hour postprandial crossover study to evaluate the satiation effects of pasta formulations on lunch intake in healthy weight women. The study design will test 3 varying pasta formulations (2 experimental and 1 standard control) in a lunch setting in relatively healthy unrestrained women.

This study will require one initial screening visit (approximately 1 hour) and three study visits each lasting approximately 4 hours. All visits should be done in 1 month. We are looking for healthy, non-smoking women older than 18 years of age with no significant medical history.

The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, blood glucose test (finger prick) and eating, health, exercise and mood surveys.

If willing and eligible to participate, subjects will have 3 study visits. At each visits, subjects will be asked to consume as much as they would like of the pasta meal and beverage in a lunch setting and thereafter will be followed for 3 hours assessing subjective feelings of satiety. The lunch meal will be provided 5 hours after a standardized breakfast (usual breakfast for each subject at the same time of day on each study visit day). During the course of the study, subjects will be instructed to maintain their usual level of activity and diet. Four day food records will be maintained throughout the course of the study.

02

Conditions studied

  • Appetite

Keywords

  • pasta
  • appetite
  • hunger
  • satiation
  • nutrition
  • Psychological Phenomena and Processes
03

In context

Lead sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Females
  • 18 years of age and older
  • Body mass index (BMI) between 18.5 and 24.9 kg/m2, inclusive
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Unrestrained eater (score \< 10 on the Three Factor Eating Questionnaire)

Exclusion criteria

Exclusion Criteria:

  • Pregnant and/or lactating or planning for pregnancy
  • Allergies or intolerances to foods consumed in the study
  • Fasting blood glucose > 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
  • Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
  • Taking prescription medications that may interfere with study procedures or endpoints ( medications that affect appetite)
  • Subjects with unusual dietary habits (e.g. pica)
  • Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)
  • Excessive exercisers or trained athletes
  • Addicted to drugs and/or alcohol
  • Medically documented psychiatric or neurological disturbances
  • Smoker (past smoker may be allowed if cessation is > 2 years)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    experimental pasta B

    Past B

    Other: Experimental pasta B

  • Experimental
    experimental pasta C

    Pasta C

    Other: Experimental pasta C

  • Placebo comparator
    Control pasta

    Control

    Other: Control pasta

Interventions

  • OtherControl pasta

    control pasta

  • OtherExperimental pasta B

    experimental pasta

  • OtherExperimental pasta C

    experimental pasta

06

What researchers measure

Primary outcomes

  1. To investigate the effect of pasta formulations incorporated into a lunch meal on satiation (meal termination) as determined by energy intake of the meal along with subjective responses on visual analog scales and subsequent food intake.

    Meals will be provided 4 1/2 hours after a standardized breakfast (subject's own usual breakfast in the same quantity at the same time before each study visit) and subjects will be able to eat as much of the pasta as they would like and may request more if desired. Immediately thereafter, subjects will record satiety responses at 0 min (immediately post consumption), 20, 40, 60, 90, 120, 150 and 180 on a visual analog scale (VAS). The subject will answer a series of questions on the VAS at each respective time point describing their feelings of hunger, fullness and desire to eat.

    Time frame: 3 hour post prandial study

07

Study locations

1 site
  • Clinical Nutrition Research Center
    Chicago, Illinois 60616, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01145963
Lead sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborators
Barilla America, Inc.
Responsible party
Sponsor
First posted
Jun 17, 2010
Start date
Jun 1, 2010
Primary completion
Dec 19, 2018
Completion
Dec 19, 2018
Last update
Jul 27, 2021

Study contacts

Britt Burton-Freeman, PhD, MS
principal investigator · Clinical Nutrition Research Center, Illinois Institute of Technology
Indika Edirisinghe, PhD
principal investigator · Clinical Nutrition Research Center, Illinois Institute of Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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