Types of Resistant Starch and Their Effect on Appetite

NCT ID: NCT01125878

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-02

Study Completion Date

2011-09-29

Brief Summary

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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

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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

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Psychological Phenomena and Processes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Starch Composite B

fiber mixture

Group Type ACTIVE_COMPARATOR

Starch composite B

Intervention Type DIETARY_SUPPLEMENT

fiber mixture

Starch Composite C

fiber mixture

Group Type ACTIVE_COMPARATOR

Starch composite C

Intervention Type DIETARY_SUPPLEMENT

fiber mixture

Starch Composite D

fiber mixture

Group Type ACTIVE_COMPARATOR

Starch composite D

Intervention Type DIETARY_SUPPLEMENT

fiber mixture

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Interventions

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Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Starch composite B

fiber mixture

Intervention Type DIETARY_SUPPLEMENT

Starch composite C

fiber mixture

Intervention Type DIETARY_SUPPLEMENT

Starch composite D

fiber mixture

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ingredion Incorporated

INDUSTRY

Sponsor Role collaborator

Clinical Nutrition Research Center, Illinois Institute of Technology

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

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Clinical Nutrition Research Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12712245 (View on PubMed)

Robertson 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.

Reference Type BACKGROUND
PMID: 16155268 (View on PubMed)

Other Identifiers

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NST 2010-027

Identifier Type: -

Identifier Source: org_study_id

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