HealthySETNCT01199770
Pasta Formulations, Portion Sizes and Their Effect on Appetite
A study testing Experimental B, small, Experimental pasta C, small and experimental pasta B, medium in people with Healthy and Appetite, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Experimental B, small, Experimental pasta C, small and experimental pasta B, medium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2010to 18 Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Understanding Pasta Formulations and Portion Size on Satiety in Healthy Weight Women
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.
Read the 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.
- Being tested
- Control, small, Experimental B, small, Experimental pasta C, small, control, medium, experimental pasta B, medium
- Keywords
- pasta, appetite, hunger, satiety, nutrition, metabolic, gut peptide hormones, psychological phenomena and processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control, smallOther
control pasta, small portion
Experimental B, smallOther
experimental pasta, small portion
Experimental pasta C, smallOther
experimental pasta C, small portion
control, mediumOther
control pasta, medium portion
experimental pasta B, mediumOther
experimental pasta B, medium portion
experimental pasta C, mediumOther
experimental pasta C, medium portion
NLOther
no pasta, water only
| Study group | Role | What they receive |
|---|---|---|
| experimental pasta B, small | Experimental | small portion experimental pasta B Receives: Other: Experimental B, small |
| experimental pasta C, small portion | Experimental | small portion experimental pasta C Receives: Other: Experimental pasta C, small |
| Control pasta, small | Placebo comparator | small portion Control pasta Receives: Other: Control, small |
| No Load | Other | Only water Receives: Other: NL |
| Control pasta, medium | Active comparator | medium portion Control pasta Receives: Other: control, medium |
| experimental pasta B, medium portion | Experimental | medium portion experimental pasta B Receives: Other: experimental pasta B, medium |
| experimental pasta C, medium portion | Experimental | medium portion experimental pasta B Receives: Other: experimental pasta C, medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 3 hour post prandial study
Secondary outcomes (1)
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
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).
Measured: 3 hour postprandial study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study start15 Sep 2010
- Primary completion18 Nov 2011
- Study completion18 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Barilla America, Inc.
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, PhD, MS, Principal investigator, Clinical Nutrition Research Center, Illinois Institute of TechnologyIndika Edirisinghe, PhD, Principal investigator, Clinical Nutrition Research Center, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199770
- Sponsor's protocol ID
- SET 2010-043
- Acronym
- SET
- Status last verified
- Jul 2021
- First submitted
- 9 Sep 2010
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Pasta Formulations and Portion Size on Satiety in Healthy Weight Women
- ClinicalTrials.gov ID
- NCT01199770
- Acronym / sponsor ID
- SET / SET 2010-043
- Keywords
- pasta, appetite, hunger, satiety, nutrition, metabolic, gut peptide hormones, psychological phenomena and processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Barilla America, Inc.
- Study start
- 15 Sep 2010 (actual)
- Primary completion
- 18 Nov 2011 (actual)
- Study completion
- 18 Nov 2011 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| experimental pasta B, small | Experimental | Other: Experimental B, smallsmall portion experimental pasta B |
| experimental pasta C, small portion | Experimental | Other: Experimental pasta C, smallsmall portion experimental pasta C |
| Control pasta, small | Placebo comparator | Other: Control, smallsmall portion Control pasta |
| No Load | Other | Other: NLOnly water |
| Control pasta, medium | Active comparator | Other: control, mediummedium portion Control pasta |
| experimental pasta B, medium portion | Experimental | Other: experimental pasta B, mediummedium portion experimental pasta B |
| experimental pasta C, medium portion | Experimental | Other: experimental pasta C, mediummedium portion experimental pasta B |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control, smallcontrol pasta, small portion | Other | Control pasta, small |
| Experimental B, smallexperimental pasta, small portion | Other | experimental pasta B, small |
| Experimental pasta C, smallexperimental pasta C, small portion | Other | experimental pasta C, small portion |
| control, mediumcontrol pasta, medium portion | Other | Control pasta, medium |
| experimental pasta B, mediumexperimental pasta B, medium portion | Other | experimental pasta B, medium portion |
| experimental pasta C, mediumexperimental pasta C, medium portion | Other | experimental pasta C, medium portion |
| NLno pasta, water only | Other | No Load |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Burton-Freeman, PhD, MS principal investigator
Clinical Nutrition Research Center, Illinois Institute of Technology
Indika Edirisinghe, PhD principal investigator
Clinical Nutrition Research Center, Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental B, small, Experimental pasta C, small and experimental pasta B, medium in people with Healthy and Appetite, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.