Psychological Phenomena and ProcessesNSTNCT01125878
Types of Resistant Starch and Their Effect on Appetite
A study testing Starch composite B, Starch composite C and Starch composite D in people with Psychological Phenomena and Processes, 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 certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber mixtures, then describe their feelings of hunger, fullness and desire to eat for the 3 hour… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Phenomena and Processes
- What is being tested?
- Starch composite B, Starch composite C and Starch composite D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2010to 29 Sep 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
- Premenopausal females
- 18 years of age and older
- BMI (body mass index) 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)
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- 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 Resistant Starch on Satiety in Premenopausal Women
Investigators are interested in learning how appetite responds to certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber mixtures, then describe their feelings of hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do this on four separate occasions. Following the 3 hour study period, a deli-style lunch will be served. Investigators want to see how appetite responds to these four different starch and fiber mixtures.
Read the detailed description
This study will require one initial screening visit (approximately 1 hour) and four study visits each lasting approximately 4 hours. All visits should be done in 2 months. We are looking for healthy, non-smoking, premenopausal female volunteers older than 18 with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, blood glucose finger prick and eating, health and mood surveys.
If willing and eligible to participate, subjects will have four study visits. All study visits will be scheduled according to each individual subject's menstrual cycle. At each visit subject will be asked to eat the cookie bar and then answer questions about their feelings of hunger, fullness and desire to eat. Subject will continue to answer questions about their feelings of hunger, fullness and desire to eat at specific time points up to 3 hours after eating the yogurt. After 3 hours a lunch meal will be served. The lunch meal consists of typical deli items, such as pasta, rolls, salad, etc. Subject will be allowed to eat as much or as little of the lunch as they'd like.
- Conditions
- Psychological Phenomena and Processes
- Being tested
- Placebo, Starch composite B, Starch composite C, Starch composite D
- Keywords
- satiety, appetite, fiber, starch, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
placebo
Starch composite BDietary supplement
fiber mixture
Starch composite CDietary supplement
fiber mixture
Starch composite DDietary supplement
fiber mixture
| Study group | Role | What they receive |
|---|---|---|
| Starch Composite B | Active comparator | fiber mixture Receives: Dietary Supplement: Starch composite B |
| Starch Composite C | Active comparator | fiber mixture Receives: Dietary Supplement: Starch composite C |
| Starch Composite D | Active comparator | fiber mixture Receives: Dietary Supplement: Starch composite D |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake.
Meals will be provided under fasting conditions and thereafter subjects will record satiety reponses at 30 mins, 60, 90, 120, 150 and 180 on a visual analog scale (VAS). The subject will answer a series of questions on the VAS describing their feelings of hunger, fullness and desire to eat at the above mentioned time points.
Satiety will also be determined on the quantity of the test lunch meal consumed. This test meal will be served three hours after consumption of the starch composites.
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 posted19 May 2010 (estimated)
- Study start2 Sep 2010
- Primary completion12 Jul 2011
- Study completion29 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological Phenomena and ProcessesStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ingredion Incorporated
- 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
- NCT01125878
- Sponsor's protocol ID
- NST 2010-027
- Acronym
- NST
- Status last verified
- Jan 2021
- First submitted
- 11 May 2010
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Robertson MD, Currie JM, Morgan LM, Jewell DP, Frayn KN. Prior short-term consumption of resistant starch enhances postprandial insulin sensitivity in healthy subjects. Diabetologia. 2003 May;46(5):659-65. doi: 10.1007/s00125-003-1081-0. Epub 2003 Apr 24.
PubMed 12712245Robertson MD, Bickerton AS, Dennis AL, Vidal H, Frayn KN. Insulin-sensitizing effects of dietary resistant starch and effects on skeletal muscle and adipose tissue metabolism. Am J Clin Nutr. 2005 Sep;82(3):559-67. doi: 10.1093/ajcn.82.3.559.
PubMed 16155268
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Resistant Starch on Satiety in Premenopausal Women
- ClinicalTrials.gov ID
- NCT01125878
- Acronym / sponsor ID
- NST / NST 2010-027
- Conditions
- Psychological Phenomena and Processes
- Keywords
- satiety, appetite, fiber, starch, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Ingredion Incorporated
- Study start
- 2 Sep 2010 (actual)
- Primary completion
- 12 Jul 2011 (actual)
- Study completion
- 29 Sep 2011 (actual)
- First posted
- 19 May 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 certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber mixtures, then describe their feelings of hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do this on four separate occasions. Following the 3 hour study period, a deli-style lunch will be served. Investigators want to see how appetite responds to these four different starch and fiber mixtures.
Detailed description
This study will require one initial screening visit (approximately 1 hour) and four study visits each lasting approximately 4 hours. All visits should be done in 2 months. We are looking for healthy, non-smoking, premenopausal female volunteers older than 18 with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, blood glucose finger prick and eating, health and mood surveys.
If willing and eligible to participate, subjects will have four study visits. All study visits will be scheduled according to each individual subject's menstrual cycle. At each visit subject will be asked to eat the cookie bar and then answer questions about their feelings of hunger, fullness and desire to eat. Subject will continue to answer questions about their feelings of hunger, fullness and desire to eat at specific time points up to 3 hours after eating the yogurt. After 3 hours a lunch meal will be served. The lunch meal consists of typical deli items, such as pasta, rolls, salad, etc. Subject will be allowed to eat as much or as little of the lunch as they'd like.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Starch Composite B | Active comparator | Dietary Supplement: Starch composite Bfiber mixture |
| Starch Composite C | Active comparator | Dietary Supplement: Starch composite Cfiber mixture |
| Starch Composite D | Active comparator | Dietary Supplement: Starch composite Dfiber mixture |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Premenopausal females
- 18 years of age and older
- BMI (body mass index) 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 |
|---|---|---|
| Placeboplacebo | Dietary supplement | Placebo |
| Starch composite Bfiber mixture | Dietary supplement | Starch Composite B |
| Starch composite Cfiber mixture | Dietary supplement | Starch Composite C |
| Starch composite Dfiber mixture | Dietary supplement | Starch Composite D |
Primary outcome
Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake.
Time frame: 3 hour postprandial study
Meals will be provided under fasting conditions and thereafter subjects will record satiety reponses at 30 mins, 60, 90, 120, 150 and 180 on a visual analog scale (VAS). The subject will answer a series of questions on the VAS describing their feelings of hunger, fullness and desire to eat at the above mentioned time points. Satiety will also be determined on the quantity of the test lunch meal consumed. This test meal will be served three hours after consumption of the starch composites.
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 Jan 2021.
- Background: PubMed 12712245Robertson MD, Currie JM, Morgan LM, Jewell DP, Frayn KN. Prior short-term consumption of resistant starch enhances postprandial insulin sensitivity in healthy subjects. Diabetologia. 2003 May;46(5):659-65. doi: 10.1007/s00125-003-1081-0. Epub 2003 Apr 24.
- Background: PubMed 16155268Robertson MD, Bickerton AS, Dennis AL, Vidal H, Frayn KN. Insulin-sensitizing effects of dietary resistant starch and effects on skeletal muscle and adipose tissue metabolism. Am J Clin Nutr. 2005 Sep;82(3):559-67. doi: 10.1093/ajcn.82.3.559.
- Individual participant dataSharing planned: No
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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 Starch composite B, Starch composite C and Starch composite D in people with Psychological Phenomena and Processes, 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 Jan 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?
Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake. (time frame: 3 hour postprandial study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01125878, which also lists 2 linked publications.
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 Jan 2021.