Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

NCT ID: NCT00958399

Last Updated: 2012-02-06

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-04-30

Brief Summary

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Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.

The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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No fiber

No fiber added to study products

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Resistant Starch

Muffins, cereal, and bars made with a resistant starch

Group Type EXPERIMENTAL

Resistant Starch

Intervention Type DIETARY_SUPPLEMENT

25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Resistant starch + soluble fiber

Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber

Group Type EXPERIMENTAL

Resistant starch + soluble fiber

Intervention Type DIETARY_SUPPLEMENT

25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Fiber made from corn starch

Muffins, cereal, and bars made with novel corn fiber

Group Type EXPERIMENTAL

Fiber made from corn starch

Intervention Type DIETARY_SUPPLEMENT

25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Fiber made from corn starch + soluble fiber

Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber

Group Type EXPERIMENTAL

Fiber made from corn starch + soluble fiber

Intervention Type DIETARY_SUPPLEMENT

25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Interventions

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Placebo

Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Intervention Type DIETARY_SUPPLEMENT

Resistant Starch

25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Intervention Type DIETARY_SUPPLEMENT

Resistant starch + soluble fiber

25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Intervention Type DIETARY_SUPPLEMENT

Fiber made from corn starch

25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Intervention Type DIETARY_SUPPLEMENT

Fiber made from corn starch + soluble fiber

25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy men and women
* age 18-60 years
* non-smoking
* not taking medication
* non-dieting (weight stable in prior 3 months)
* BMI 18-27
* English literacy
* ability to give blood

Exclusion Criteria

* do not regularly consume breakfast
* food allergies to ingredients found in study products
* dislike for muffins, fiber bars, or hot cereal
* BMI \<18 or \>27
* diagnosed cardiovascular, renal, or hepatic disease
* diabetes mellitus (fasting blood sugar \>126 mg/dl)
* cancer in previous 5 years (except basal cell carcinoma of the skin)
* any gastrointestinal disease or condition
* recent bacterial infection (\< 3 months)
* recent or concurrent participation in an intervention research study
* history of drug or alcohol abuse in prior 6 months
* use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
* restrained eaters
* vegetarians
* people who eat more than approximately 15 grams of fiber per day
* women who are pregnant or lactating
* women with irregular menstrual cycles
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tate and Lyle Ingredients France

INDUSTRY

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne L Slavin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota - General Clinical Research Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20.

Reference Type DERIVED
PMID: 23427334 (View on PubMed)

Other Identifiers

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0701M00264

Identifier Type: -

Identifier Source: org_study_id

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