NCT01792596

Brief Summary

The combination of fiber and protein added to pasta will enhance satiety.

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

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

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

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

January 22, 2013

Last Update Submit

January 6, 2014

Conditions

Food Selection

Outcome Measures

Primary Outcomes (1)

  • satiety

    180 minutes

Study Arms (3)

pasta

OTHER

1\. Plain pasta

Other: Pasta

pasta with protein

OTHER

Pasta with protein

Other: Pasta with protein

pasta with fiber

OTHER

Pasta with Fiber

Other: Pasta with Fiber

Interventions

Pasta with proteinOTHER

Pasta with Protein

pasta with protein
Pasta with FiberOTHER

Pasta with Fiber

pasta with fiber
PastaOTHER

Pasta

pasta

Eligibility Criteria

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

You may qualify if:

  • healthy
  • nonsmoking
  • body mass index from 19 - 29

You may not qualify if:

  • Antibiotic use
  • any disease
  • weight loss
  • food allergies
  • high fiber intake
  • restrained eater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Food Preferences

Interventions

ProteinsDietary Fiber

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Joanne Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

February 15, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)