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Types of Resistant Starch and Their Effect on Appetite

Understanding Resistant Starch on Satiety in Premenopausal Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01125878
Acronym
NST
Enrollment
40
Registered
2010-05-19
Start date
2010-09-02
Completion date
2011-09-29
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Phenomena and Processes

Keywords

satiety, appetite, fiber, starch, nutrition

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTPlacebo

placebo

DIETARY_SUPPLEMENTStarch composite B

fiber mixture

DIETARY_SUPPLEMENTStarch composite C

fiber mixture

DIETARY_SUPPLEMENTStarch composite D

fiber mixture

Sponsors

Ingredion Incorporated
CollaboratorINDUSTRY
Clinical Nutrition Research Center, Illinois Institute of Technology
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

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)

Design outcomes

Primary

MeasureTime frameDescription
Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake.3 hour postprandial studyMeals 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026