Pasta Formulations, Portion Sizes and Their Effect on Appetite (SET)

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:
NCT01199770
First received: September 9, 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 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.


Condition Intervention
Healthy
Appetite
Other: Control, small
Other: Experimental B, small
Other: Experimental pasta C, small
Other: control, medium
Other: experimental pasta B, medium
Other: experimental pasta C, medium
Other: NL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Understanding Pasta Formulations and Portion Size on Satiety 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 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 ] [ Designated as safety issue: No ]
    Meals will be provided 4 1/2 hours after a standardized breakfast and subjects must eat the entire pasta serving. After the pasta serving, a buffet lunch will be served and subjects may eat as much as 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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Meals will be provided 4 1/2 hours after a standardized breakfast and subjects must eat the entire pasta serving. After the pasta serving, a buffet lunch will be served and subjects may eat as much as desired. Immediately thereafter, subjects will have blood drawn at 0 min (immediately post consumption), 20, 40, 60, 90, 120, 150 and 180. Blood samples will be drawn for measurement of plasma lipids, glucose, insulin and gut peptide hormones (GLP-1 and PYY).


Enrollment: 24
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: experimental pasta B
small portion
Other: Experimental B, small
experimental pasta, small portion
Experimental: experimental pasta C, small portion
small portion
Other: Experimental pasta C, small
experimental pasta C, small portion
Placebo Comparator: Control pasta, small
small portion
Other: Control, small
control pasta, small portion
No Load Other: NL
no pasta, water only
Active Comparator: Control pasta, medium
medium portion
Other: control, medium
control pasta, medium portion
Experimental: experimental pasta B, medium portion
medium portion
Other: experimental pasta B, medium
experimental pasta B, medium portion
Experimental: experimental pasta C, medium portion
medium portion
Other: experimental pasta C, medium
experimental pasta C, medium portion

Detailed 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.

  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: NCT01199770

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: NCT01199770     History of Changes
Other Study ID Numbers: SET 2010-043
Study First Received: September 9, 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
satiety
nutrition
metabolic
gut peptide hormones
psychological phenomena and processes

ClinicalTrials.gov processed this record on October 21, 2014