Pasta Formulations and Their Effect on Appetite

NCT ID: NCT01145963

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2018-12-19

Brief Summary

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.

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.

Conditions

Appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

experimental pasta B

Past B

Group Type: EXPERIMENTAL

Experimental pasta B

Intervention Type: OTHER

experimental pasta

experimental pasta C

Pasta C

Group Type: EXPERIMENTAL

Experimental pasta C

Intervention Type: OTHER

experimental pasta

Control pasta

Control

Group Type: PLACEBO_COMPARATOR

Control pasta

Intervention Type: OTHER

control pasta

Interventions

Control pasta

control pasta

Intervention Type: OTHER

Experimental pasta B

experimental pasta

Intervention Type: OTHER

Experimental pasta C

experimental pasta

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Barilla America, Inc.

INDUSTRY

Sponsor Role: collaborator

Clinical Nutrition Research Center, Illinois Institute of Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Britt Burton-Freeman, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Research Center, Illinois Institute of Technology

Indika Edirisinghe, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Research Center, Illinois Institute of Technology

Locations

Clinical Nutrition Research Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

SAT 2010-042

Identifier Type: -

Identifier Source: org_study_id