NCT00776256

Brief Summary

The effect of beta-glucan or fructo-oligosaccharide or their combination in bars on satiety and food intake was tested by supplying these bars on two consecutive days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

28 days

First QC Date

October 18, 2008

Last Update Submit

October 20, 2008

Conditions

Appetite Regulation

Keywords

satietyfood intake

Outcome Measures

Primary Outcomes (1)

  • Satiety and food intake

    2 days each week for 4 weeks

Study Arms (4)

1

ACTIVE COMPARATOR

effect of beta-glucan

Dietary Supplement: beta-glucan and fructooligosaccharide

2

ACTIVE COMPARATOR

effect of fructo-oligosaccharide

Dietary Supplement: beta-glucan and fructooligosaccharide

3

ACTIVE COMPARATOR

effect of beta-glucan and fructooligosaccharide

Dietary Supplement: beta-glucan and fructooligosaccharide

4

PLACEBO COMPARATOR

no beta-glucan nor fructooligosaccharide

Dietary Supplement: beta-glucan and fructooligosaccharide

Interventions

beta-glucan and fructooligosaccharideDIETARY_SUPPLEMENT

1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2

Also known as: oats, barley, oligofructose
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Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age at start of the study 18 till 60 years
  • Quetelet-Index (BMI) from 21 till 32 kg/m2 inclusive
  • Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders
  • Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian, macro-biotic or biologic dynamic food habits
  • No Fibre supplements (only once a day)
  • No blood donations during the study.
  • Reported intense sporting activities less than 10h/w
  • Reported alcohol consumption less than 21 units/w (female volunteers) or less than 28 units/w (male volunteers)
  • Having a General Practitioner
  • Informed consent signed
  • Recruitment form filled out

You may not qualify if:

  • Smoking
  • Dislike, allergy/intolerance or not known with the foods of the ad libitum meal
  • Possible eating disorder (measured by SCOFF questionnaire)
  • High or very high restrained eaters (measured by questionnaire) (men with BMI \< 27: restraint score \> 2.37, men with BMI less than 27: restraint score \> 3.04, women with BMI \< 26: restraint score \> 3.24, women with BMI less than 26: restraint score \> 3.41)
  • Reported medical treatment that may affect eating habits/satiety
  • Reported intolerance or allergy to test products
  • Women reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 3 months ago) or wish to become pregnant during the study
  • Reported weight loss/gain (10%) in the last six month before the trial
  • Reported participation in another biomedical trial 1 month before the start of the study
  • Reported working on late turns -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unilever R&D Vlaardingen

Vlaardingen, 3133AT, Netherlands

Location

Related Publications (1)

  • Peters HP, Boers HM, Haddeman E, Melnikov SM, Qvyjt F. No effect of added beta-glucan or of fructooligosaccharide on appetite or energy intake. Am J Clin Nutr. 2009 Jan;89(1):58-63. doi: 10.3945/ajcn.2008.26701. Epub 2008 Dec 3.

    PMID: 19056555DERIVED

MeSH Terms

Interventions

beta-Glucansfructooligosaccharideoligofructose

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Study Officials

  • Edward Haddeman

    Unilever R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2008

First Posted

October 21, 2008

Study Start

February 1, 2007

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

NL(1)