Pasta Formulations and Their Effect on Appetite (SAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Barilla America
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT01145963
First received: June 15, 2010
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Appetite
Other: Control pasta
Other: Experimental pasta B
Other: Experimental pasta C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Understanding Pasta Formulations on Satiation in Healthy Weight Women

Further study details as provided by Institute for Food Safety and Health, United States:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 hour post prandial study ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: June 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental pasta B Other: Experimental pasta B
experimental pasta
Experimental: experimental pasta C Other: Experimental pasta C
experimental pasta
Active Comparator: Control pasta Other: Control pasta
control pasta

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145963

Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Barilla America
Investigators
Principal Investigator: Britt Burton-Freeman, PhD, MS Institute for Food Safety and Health, United States
Principal Investigator: Indika Edirisinghe, PhD Institute for Food Safety and Health, United States
  More Information

No publications provided

Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT01145963     History of Changes
Other Study ID Numbers: SAT 2010-042
Study First Received: June 15, 2010
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Food Safety and Health, United States:
pasta
appetite
hunger
satiation
nutrition
Psychological Phenomena and Processes

ClinicalTrials.gov processed this record on August 01, 2014