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Effects of Oligofructose and Barley on Satiety and Energy Intake

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ClinicalTrials.gov Identifier: NCT00776256
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Unilever R&D

Tracking Information
First Submitted Date  ICMJE October 18, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date October 21, 2008
Study Start Date  ICMJE February 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Satiety and food intake [ Time Frame: 2 days each week for 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oligofructose and Barley on Satiety and Energy Intake
Official Title  ICMJE The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Appetite Regulation
Intervention  ICMJE Dietary Supplement: 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
Study Arms  ICMJE
  • Active Comparator: 1
    effect of beta-glucan
    Intervention: Dietary Supplement: beta-glucan and fructooligosaccharide
  • Active Comparator: 2
    effect of fructo-oligosaccharide
    Intervention: Dietary Supplement: beta-glucan and fructooligosaccharide
  • Active Comparator: 3
    effect of beta-glucan and fructooligosaccharide
    Intervention: Dietary Supplement: beta-glucan and fructooligosaccharide
  • Placebo Comparator: 4
    no beta-glucan nor fructooligosaccharide
    Intervention: Dietary Supplement: beta-glucan and fructooligosaccharide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2008)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776256
Other Study ID Numbers  ICMJE 07002V
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harry Peters, Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edward Haddeman Unilever R&D
PRS Account Unilever R&D
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP