Effects of Oligofructose and Barley on Satiety and Energy Intake

NCT ID: NCT00776256

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Background: Increasing gastro-intestinal viscosity or colonic fermentation is suggested to help improve appetite control and reduce food intake. Beta-glucan (BG) and fructo-oligosaccharide (FOS) are food ingredients proposed to act this way, but results so far remain inconclusive.

Objective: To test the effect of FOS, BG, or their combination in bars on appetite ratings and food intake during 2 consecutive days.

Design: In a 4-way balanced order cross-over double-blind design, 21 healthy volunteers (mean BMI 25.9 kg/m2) received a meal replacement bar at 09.00h and an ad libitum lunch at 13.00h on 2 consecutive days. On day 1 only, subjects consumed a second (identical) bar at 17.00h and a fixed snack at 19.00h. The control bar contained 0.3g BG (control, from 6.8 g oats), vs equi-caloric bar formulations containing an additional: 1) 0.9 g BG (from 8.0g barley), 2) 8g FOS, or 3) 0.9 g BG + 8g FOS. Appetite scores and subsequent ad libitum test meal intakes were measured. Bar viscosities were determined under simulated gastric conditions. Results were analyzed using ANCOVA.

Results: Addition of BG, FOS or their combination did not affect appetite ratings or food intake, although addition of BG to the bar doubled apparent gastric viscosity (841 vs 351 mPa.s).

Conclusions: BG, FOS or their combination in bars at these levels do not improve appetite control when consumed on 2 consecutive days. Efficacy might be increased by a longer exposure period, increasing the BG content, or a form of BG that generates even higher gastric viscosity.

Conditions

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Appetite Regulation

Keywords

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satiety food intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

effect of beta-glucan

Group Type ACTIVE_COMPARATOR

beta-glucan and fructooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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

2

effect of fructo-oligosaccharide

Group Type ACTIVE_COMPARATOR

beta-glucan and fructooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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

3

effect of beta-glucan and fructooligosaccharide

Group Type ACTIVE_COMPARATOR

beta-glucan and fructooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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

4

no beta-glucan nor fructooligosaccharide

Group Type PLACEBO_COMPARATOR

beta-glucan and fructooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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beta-glucan and fructooligosaccharide

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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oats barley oligofructose

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Unilever R&D

Principal Investigators

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Edward Haddeman

Role: STUDY_DIRECTOR

Unilever R&D

Locations

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Unilever R&D Vlaardingen

Vlaardingen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 19056555 (View on PubMed)

Other Identifiers

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07002V

Identifier Type: -

Identifier Source: org_study_id