Satiety Response After Mixed Fiber Doses

NCT ID: NCT00889993

Last Updated: 2012-03-29

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

2007-11-30

Study Completion Date

2008-10-31

Brief Summary

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People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.

The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.

Detailed Description

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Conditions

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Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Mixed Fiber Supplement

Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* English speaking
* healthy men and women
* 18 and 65 years of age
* non-smoking
* not taking medications
* non-dieting (weight stable over last 3 months)
* BMI between 18 and 27
* able to give blood through an IV

Exclusion Criteria

* irregular or erratic breakfast eating patterns
* food allergies to ingredients commonly found in muffins or pizza
* distaste for muffins or pizza
* BMI less than 18 or greater than 27
* weight change \> 5 kg in last 3 months (intentional or unintentional)
* cardiovascular disease
* diabetes mellitus (fasting blood sugar \> 126 mg/dl)
* cancer in prior 5 years (except basal cell carcinoma of skin)
* renal or hepatic disease
* Crohns disease
* ulcerative colitis
* any other gastrointestinal conditions that may affect digestion or absorption
* recent bacterial infection (\< 3 months)
* chronic medication use
* history of drug or alcohol abuse in prior 6 months
* concurrent or recent intervention study participation
* vegetarians
* people who ate more than approximately 15 g of fiber per day
* pregnant or lactating women
* women with irregular menstrual cycles
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

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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Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.

Reference Type DERIVED
PMID: 21310305 (View on PubMed)

Other Identifiers

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0701M00265

Identifier Type: -

Identifier Source: org_study_id

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