Effects of Oligofructose and Barley on Satiety and Energy Intake

October 20, 2008 updated by: Unilever R&D

The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vlaardingen, Netherlands, 3133AT
        • Unilever R&D Vlaardingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
effect of beta-glucan
1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2
Other Names:
  • oats
  • barley
  • oligofructose
ACTIVE_COMPARATOR: 2
effect of fructo-oligosaccharide
1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2
Other Names:
  • oats
  • barley
  • oligofructose
ACTIVE_COMPARATOR: 3
effect of 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
Other Names:
  • oats
  • barley
  • oligofructose
PLACEBO_COMPARATOR: 4
no beta-glucan nor fructooligosaccharide
1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2
Other Names:
  • oats
  • barley
  • oligofructose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satiety and food intake
Time Frame: 2 days each week for 4 weeks
2 days each week for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Edward Haddeman, Unilever R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

October 18, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (ESTIMATE)

October 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 20, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07002V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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