NCT01588600

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

April 10, 2012

Last Update Submit

April 20, 2016

Conditions

Obesity

Keywords

food intake, satiety, fiber

Outcome Measures

Primary Outcomes (1)

  • Food intake

    24-hour Food intake will be measured 3 times

    24-hr food intake, on three occasions within 3 weeks

Secondary Outcomes (1)

  • Subjective appetite ratings

    Hourly, over 8 hrs, on 3 days within a 3-week period

Study Arms (3)

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

Dietary FiberOTHER

Fiber added to breakfast

ControlHigh-doseLow-dose

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal-weight adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kissileff Laboratory for the Study of Human Ingestive Behavior

Liverpool, L69 7ZA, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jason Halford, PhD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

May 1, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 21, 2016

Record last verified: 2012-04

Locations

GB(1)