NCT01102881

Brief Summary

Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Therefore as new dietary fibers are created or discovered the laxative and satiating effects should be investigated in order to verify these effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

8 months

First QC Date

March 23, 2010

Last Update Submit

September 8, 2010

Conditions

Healthy

Keywords

Healthy adults

Outcome Measures

Primary Outcomes (1)

  • Whole gut transit time determined by radio-opaque pellets

    Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets

    5 day fecal collection

Secondary Outcomes (5)

  • Satiety

    0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially

  • Breath Hydrogen concentration after consumption of test cereal

    0 and 240 minutes postprandially

  • Ad libitum food intake

    24 hours, 48 hours, and 10 days after the start of treatment

  • Gastrointestinal Tolerance

    24 hours, 48 hours, and 10 days after the start of the treatment

  • Fecal chemistry

    6-10 days after the start of treatments

Study Arms (3)

No fiber

PLACEBO COMPARATOR

No fiber added to muffins or cereal

Dietary Supplement: placebo

Fiber made from corn starch

EXPERIMENTAL

Muffins and cereal made with novel corn fiber

Dietary Supplement: Fiber made from corn starch

Glucose polymer fiber

EXPERIMENTAL

Muffins and cereal made from glucose polymer fiber

Dietary Supplement: Glucose polymer fiber

Interventions

Glucose polymer fiberDIETARY_SUPPLEMENT

20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin

Glucose polymer fiber
Fiber made from corn starchDIETARY_SUPPLEMENT

20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin

Also known as: Dietary fiber made from corn starch
Fiber made from corn starch
placeboDIETARY_SUPPLEMENT

low fiber breakfast cereal and muffin

No fiber

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men and women
  • age 18-65
  • non-smoking
  • not taking medication
  • non-dieting (weight stable in prior 3 months)
  • BMI 18-30
  • English literacy

You may not qualify if:

  • do not regularly consume breakfast
  • food allergies to ingredients found in study product
  • dislike of cereal or muffins
  • BMI \<18 or \>30
  • diagnosed with cardiovascular, renal, or hepatic disease
  • diabetes mellitus (fasting blood glucose \> 126 mg/ml)
  • 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 medications vegetarians people who eat more than approximately 15 grams of dietary fiber per day women who are pregnant or lactating women with irregular menstrual cycles consumption of prebiotics or probiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Study Officials

  • Joanne L Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

April 13, 2010

Study Start

August 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations

US(1)