Effects of Fiber on Satiety | NCT01588600

Studies
Effects of Fiber on Satiety

NCT01588600

Sponsor

Ingredion Incorporated

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

90Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Dietary Fiber

Countries

United Kingdom

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

Apr 2012

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

Apr 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

Apr 27, 2012

First Posted Date

May 1, 2012Estimated

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

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

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 effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.

Detailed Description

Not provided

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Breakfast without fiber	Other: Dietary Fiber
Low-dose	Experimental	Low-dose of fiber in breakfast	Other: Dietary Fiber
High-dose	Experimental	high dose of fiber added to breakfast	Other: Dietary Fiber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Fiber	Other	Fiber added to breakfast	Control High-dose Low-dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Food intake	24-hour Food intake will be measured 3 times	24-hr food intake, on three occasions within 3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Subjective appetite ratings	Ratings of hunger and fullness will be assessed 18 times	Hourly, over 8 hrs, on 3 days within a 3-week period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal-weight adults

Exclusion Criteria:

eating disorders,
on medications that affect food intake,
pregnant or lactating,
non-breakfast eaters

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Halford, PhD	University of Liverpool	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kissileff Laboratory for the Study of Human Ingestive Behavior		Liverpool		L69 7ZA	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided