NCT02689791

Brief Summary

A randomized, single-blind, cross-over study was conducted to determine the effect of replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite and food intake in healthy adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

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

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 7, 2016

Last Update Submit

February 18, 2016

Conditions

Feeding Behavior

Keywords

AppetiteFood IntakeSatiety Hormones

Outcome Measures

Primary Outcomes (1)

  • Caloric intake

    calories consumed at post-treatment lunch meal and total calories consumed on the treatment day

    Single Day

Secondary Outcomes (3)

  • Visual analogue scale measures of subjective appetite

    Single Day

  • Serum concentrations of biomarkers of appetite

    150 minutes

  • Plasma concentrations of biomarkers of glycemic response

    150 minutes

Study Arms (2)

Control (SWF)

NO INTERVENTION

Standard Wheat Flour (SWF) Muffins

Resistant Starch Type 4

EXPERIMENTAL

Resistant Wheat Starch Muffins

Dietary Supplement: Resistant Starch Type 4

Interventions

Resistant Starch Type 4DIETARY_SUPPLEMENT

single dose 26g fiber given at the breakfast meal

Also known as: Fibersym
Resistant Starch Type 4

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5-29.9 kg/m2
  • Regular breakfast consumers (\>5 days/week)

You may not qualify if:

  • not weight stable (?3 kg weight change in previous 3 months)
  • use/used tobacco products
  • presence of acute or chronic illness
  • restrained eater (\>13 on the restraint section of the three-factor eating questionnaire)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 24, 2016

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

August 1, 2014

Last Updated

February 24, 2016

Record last verified: 2016-02