NCT01257295

Brief Summary

Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 26, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

December 8, 2010

Last Update Submit

December 23, 2011

Conditions

Keywords

dietary fiberenergy intakeappetitesatiety hormonesglucosegastric emptying

Outcome Measures

Primary Outcomes (1)

  • energy intake

    3 hours after ingesting the test breakfast ad libitum energy intake is measured.

    3 hours

Secondary Outcomes (4)

  • appetite sensations

    3 hours

  • satiety hormones

    3 hours

  • gastric emptying rate

    3 hours

  • method of supplementation

    3 hours

Study Arms (6)

control

PLACEBO COMPARATOR

No additions of fiber to a breakfast meal

Dietary Supplement: control: no fiber addition

low viscous, low gelling

ACTIVE COMPARATOR

low viscous, low gelling fibre added to breakfast meal

Dietary Supplement: breakfast with low viscous, low gelling pectin

high viscous, low gelling

ACTIVE COMPARATOR

high viscous, low gelling fibre added to breakfast meal

Dietary Supplement: high viscous, low gelling pectin

low viscous, high gelling

ACTIVE COMPARATOR

low viscous, high gelling fibre added to breakfast meal

Dietary Supplement: low viscous, high gelling pectin

high viscous, high gelling

ACTIVE COMPARATOR

high viscous, high gelling fibre added to breakfast meal

Dietary Supplement: high viscous, high gelling pectin

fibre supplement

ACTIVE COMPARATOR

high viscous, high gelling fibre is added, not to the breakfast meal, but as supplement

Dietary Supplement: pectin supplement

Interventions

control: no fiber additionDIETARY_SUPPLEMENT

liquid breakfast without addition of fiber

control

10g of low viscous, low gelling pectin dissolved in a liquid breakfast

low viscous, low gelling

10g of high viscous, low gelling pectin dissolved in a liquid breakfast

high viscous, low gelling

10g of low viscous, high gelling pectin dissolved in a liquid breakfast

low viscous, high gelling

10g of high viscous, high gelling pectin dissolved in a liquid breakfast

high viscous, high gelling
pectin supplementDIETARY_SUPPLEMENT

10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately

fibre supplement

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30 year
  • BMI 18.5-25 kg/m2
  • Healthy as judged by the participant

You may not qualify if:

  • Females
  • Weight loss or weight gain of more than 5 kg during the last 2 months
  • Using an energy restricted diet during the last 2 months
  • Lack of appetite for any reason
  • Restrained eater: \>2.89, measured by DEBQ (35).
  • Smoking
  • Heavy alcohol use: \>5 drinks/day (36).
  • Reported stomach or bowel disease
  • Reported diabetes
  • Reported thyroid disease or any other endocrine disorder
  • Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods
  • Anemia: Hb\<8.0 mmol/l
  • Fasting glucose levels \>5.8 mmol/l
  • Blood donation from 6 weeks prior to the study until the end of the study
  • Experienced any problems with drawing blood in the past
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 6702, Netherlands

Location

MeSH Terms

Interventions

Breakfast

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Edith Feskens, PHd

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 9, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 26, 2011

Record last verified: 2011-12

Locations