Satiety Effects of Protein and Fiber Added to Pasta | NCT01792596

Studies
Satiety Effects of Protein and Fiber Added to Pasta

NCT01792596

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Jan 7, 2014Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Food Selection

Interventions

Pasta with protein
Pasta with Fiber
Pasta

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jan 22, 2013

First Submission Date that Met QC Criteria

Feb 14, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2014

Last Update Posted Date

Jan 7, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Subjects will consume 3 different pasta lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pasta with protein	Other	Pasta with Protein	pasta with protein
Pasta with Fiber

Measure	Description	Time Frame
satiety		180 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
nonsmoking
body mass index from 19 - 29

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanne Slavin, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Food Science and Nutrition		Saint Paul	Minnesota	55108	United States

Condition Browse Module

MeSH Terms

ID	Term
D005518	Food Preferences

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011506	Proteins
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D000602	Amino Acids, Peptides, and Proteins
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food

Browse Leaves

Not provided

Browse Branches

Not provided