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CompletedNCT01257295ProVeUpdated Dec 26, 2011

Properties of Dietary Fibre and Energy Intake

An interventional study of control: no fiber addition and breakfast with low viscous, low gelling pectin in Healthy Male Subjects, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-26.

Sponsored by Wageningen University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Male Subjects

Keywords

  • dietary fiber
  • energy intake
  • appetite
  • satiety hormones
  • glucose
  • gastric emptying
03

In context

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Antecubital veins not considered suitable for blood drawing by means of a catheter
  • Thesis students or employees of the division of Human Nutrition
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
29 participants (actual)

Study arms

  • Placebo comparator
    control

    No additions of fiber to a breakfast meal

    Dietary Supplement: control: no fiber addition

  • Active comparator
    low viscous, low gelling

    low viscous, low gelling fibre added to breakfast meal

    Dietary Supplement: breakfast with low viscous, low gelling pectin

  • Active comparator
    high viscous, low gelling

    high viscous, low gelling fibre added to breakfast meal

    Dietary Supplement: high viscous, low gelling pectin

  • Active comparator
    low viscous, high gelling

    low viscous, high gelling fibre added to breakfast meal

    Dietary Supplement: low viscous, high gelling pectin

  • Active comparator
    high viscous, high gelling

    high viscous, high gelling fibre added to breakfast meal

    Dietary Supplement: high viscous, high gelling pectin

  • Active comparator
    fibre supplement

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

    Dietary Supplement: pectin supplement

Interventions

  • Dietary supplementcontrol: no fiber addition

    liquid breakfast without addition of fiber

  • Dietary supplementbreakfast with low viscous, low gelling pectin

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

  • Dietary supplementhigh viscous, low gelling pectin

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

  • Dietary supplementlow viscous, high gelling pectin

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

  • Dietary supplementhigh viscous, high gelling pectin

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

  • Dietary supplementpectin supplement

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

06

What researchers measure

Primary outcomes

  1. energy intake

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

    Time frame: 3 hours

Secondary outcomes

  1. appetite sensations

    appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast

    Time frame: 3 hours

  2. satiety hormones

    satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast

    Time frame: 3 hours

  3. gastric emptying rate

    gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast

    Time frame: 3 hours

  4. method of supplementation

    One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.

    Time frame: 3 hours

07

Study locations

1 site
  • Wageningen University
    Wageningen, 6702, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01257295
Lead sponsor
Wageningen University
Responsible party
Sponsor
First posted
Dec 9, 2010
Start date
Dec 2010
Primary completion
May 2011
Completion
May 2011
Last update
Dec 26, 2011

Study contacts

Edith Feskens, PHd
principal investigator · Wageningen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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