Pasta Formulations and Their Effect on Appetite

NCT01145963 | Completed

• 1 other identifier: SAT 2010-042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite

Keywords

pasta; appetite; hunger; satiation; nutrition; Psychological Phenomena and Processes

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 hour post prandial study

Study Arms (3)

experimental pasta B

EXPERIMENTAL

Past B

Other: Experimental pasta B

experimental pasta C

EXPERIMENTAL

Pasta C

Other: Experimental pasta C

Control pasta

PLACEBO COMPARATOR

Control

Other: Control pasta

Interventions

Control pasta OTHER

control pasta

Control pasta

Experimental pasta B OTHER

experimental pasta

experimental pasta B

Experimental pasta C OTHER

experimental pasta

experimental pasta C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Barilla America, Inc.: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, PhD, MS

  Clinical Nutrition Research Center, Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

• Indika Edirisinghe, PhD

  Clinical Nutrition Research Center, Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 17, 2010
• Study Start: June 1, 2010
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

US (1)