NCT01187875

Brief Summary

Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 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

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

June 21, 2010

Last Update Submit

March 28, 2012

Conditions

Healthy Adults

Keywords

satiety, dietary fiber

Outcome Measures

Primary Outcomes (9)

  • Satiety response using visual analogue scales

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    0 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    15 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    30 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    45 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    60 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    90 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    120 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    180 minutes postprandially

  • Satiety response using VAS

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

    240 minutes postprandially

Secondary Outcomes (3)

  • Ad libitum food intake

    240 minutes postprandially and over 24 hours

  • Breath hydrogen response

    0, 240 minutes

  • Gastrointestinal tolerance using visual analogue scales (VAS)

    24 hours

Study Arms (4)

Control

PLACEBO COMPARATOR

Dextrin Control

Dietary Supplement: Placebo- Fiber free control

Hi-maize resistant starch 9g

EXPERIMENTAL

Hi-maize resistant starch 9g

Dietary Supplement: Hi-maize resistant starch 9g

Novalose 330 resistant starch 9g

EXPERIMENTAL

Novalose 330 resistant starch 9g

Dietary Supplement: Novalose 330 resistant starch 9g

4.5g Hi-maize and 4.5g Novalose 330

EXPERIMENTAL

4.5g Hi-maize and 4.5g Novalose 330

Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330

Interventions

Placebo- Fiber free controlDIETARY_SUPPLEMENT

Dextrin control administered in a muffin treatment.

Control
Hi-maize resistant starch 9gDIETARY_SUPPLEMENT

9g Hi-maize resistant starch administered in a muffin treatment.

Hi-maize resistant starch 9g
Novalose 330 resistant starch 9gDIETARY_SUPPLEMENT

9g Novalose 330 resistant starch administered in a muffin treatment.

Novalose 330 resistant starch 9g
4.5g Hi-maize resistant starch and 4.5g Novalose 330DIETARY_SUPPLEMENT

4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.

4.5g Hi-maize and 4.5g Novalose 330

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Age 18-64 years
  • Non-smoking
  • Not taking medication
  • Non dieting (weight stable in prior 3 months)
  • BMI 18-27
  • English literacy

You may not qualify if:

  • Do not regularly consume breakfast
  • Food allergies to ingredients found in the study products
  • BMI \<18 or \>27
  • Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus
  • Cancer in previous 5 years
  • Any gastrointestinal disease or condition
  • Recent bacterial infection (\< 3months)
  • 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
  • Eating disorder
  • Vegetarians
  • People who eat more than approximately 15 grams of fiber per day
  • Women who are pregnant or lactating
  • Women with irregular menstrual cycles

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
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2010

First Posted

August 24, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations

US(1)