Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01199770 |
| Other study ID # |
SET 2010-043 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2010 |
| Est. completion date |
November 18, 2011 |
Study information
| Verified date |
July 2021 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
