Pasta Formulations and Their Effect on Appetite (SAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01145963|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2010
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Appetite||Other: Control pasta Other: Experimental pasta B Other: Experimental pasta C||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Understanding Pasta Formulations on Satiation in Healthy Weight Women|
|Actual Study Start Date :||June 1, 2010|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
|Experimental: experimental pasta B||
Other: Experimental pasta B
|Experimental: experimental pasta C||
Other: Experimental pasta C
|Active Comparator: Control pasta||
Other: Control pasta
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145963
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|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|