This trial is active, not recruiting.

Conditions healthy, appetite
Treatments control, small, experimental b, small, experimental pasta c, small, control, medium, experimental pasta b, medium, experimental pasta c, medium, nl
Sponsor Institute for Food Safety and Health, United States
Collaborator Barilla America, Inc.
Start date September 2010
End date December 2017
Trial size 24 participants
Trial identifier NCT01199770, SET 2010-043


Investigators are interested in learning how appetite responds to pasta containing different amounts of protein and fiber when provided in two different portion sizes.

In this research study, subjects will be asked to eat an entire pasta serving containing different amounts of protein and fiber mixtures. Subjects will be asked to do this on six separate occasions. One time subjects will not receive pasta, only water.

After the pasta serving, there will be a buffet of deli style lunch items and subjects may eat as much they desire. Thereafter subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours. In addition, blood will be taken throughout the study period to determine how eating pasta servings in different portion sizes impacts certain hormones released from the intestine, and therefore how they influence appetite. All study visits will take approximately 4 ½ - 5 hours.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
(Active Comparator)
small portion
experimental b, small
experimental pasta, small portion
small portion
experimental pasta c, small
experimental pasta C, small portion
(Placebo Comparator)
small portion
control, small
control pasta, small portion
no pasta, water only
(Active Comparator)
medium portion
control, medium
control pasta, medium portion
medium portion
experimental pasta b, medium
experimental pasta B, medium portion
medium portion
experimental pasta c, medium
experimental pasta C, medium portion

Primary Outcomes

To investigate the effect of pasta formulations and portion size incorporated into a lunch meal on satiety (inhibition of further eating) as determined by subsequent second meal intake along with subjective responses on visual analog scales
time frame: 3 hour post prandial study

Secondary Outcomes

To investigate the effect of pasta formulations and portion size incorporated into a lunch meal on postprandial intestinal phase mechanisms of satiety and meal-associated metabolic response patterns
time frame: 3 hour postprandial study

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Understanding Pasta Formulations and Portion Size on Satiety in Healthy Weight Women
Principal investigator Britt Burton-Freeman, PhD, MS
Description The study is a randomized, 7-arm, treatment-controlled, within-subjects, 3-hour postprandial crossover study to evaluate the satiety and metabolic effects of pasta formulations in 2 portion sizes on lunch intake in healthy weight women. The study design will test 3 varying pasta formulations (2 experimental and 1 standard control) at 2 fixed portion sizes in a preload plus test lunch setting in relatively healthy unrestrained women. This study will require one initial screening visit (approximately 1 hour) and seven study visits each lasting approximately 5 hours. All visits should be completed within 2 months. 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, vital signs, blood glucose test (finger prick) and completion of a series of surveys relating to eating, health, exercise and mood. If willing and eligible to participate, subjects will have seven study visits. The pasta meal will be provided 5 hours after a standardized breakfast which is considered the usual breakfast for each subject at the same time of day on each study visit day. Upon arrival at each visit, subjects will have anthropometric measurements, vital signs and blood glucose finger prick. Thereafter, subjects will document subjective feelings of satiety followed by a blood draw. Upon completion of pre-study procedures, subjects will be asked to consume an entire pasta serving (with the exception of one visit, where no pasta will be served). Shortly thereafter, subjects will be served a buffet lunch and they may eat as desired, asking for more if desired. Throughout the study and after the lunch buffet, subjects will be followed for 3 hours assessing subjective feelings of satiety at designated time points along with blood draws measuring metabolic associated meal responses. 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institute for Food Safety and Health, United States.