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Effects of Oligofructose and Barley on Satiety and Energy Intake

This study has been completed.
Sponsor:
Information provided by:
Unilever R&D
ClinicalTrials.gov Identifier:
NCT00776256
First received: October 18, 2008
Last updated: October 20, 2008
Last verified: October 2008
History of Changes
  Purpose
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.

Condition Intervention
Appetite Regulation
 Dietary Supplement: beta-glucan and fructooligosaccharide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake

Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Satiety and food intake [ Time Frame: 2 days each week for 4 weeks ] [ Designated as safety issue: No ]
Enrollment: 24
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
effect of beta-glucan
 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
Active Comparator: 2
effect of fructo-oligosaccharide
 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
Active Comparator: 3
effect of beta-glucan and fructooligosaccharide
 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
Placebo Comparator: 4
no beta-glucan nor fructooligosaccharide
 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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776256

Locations
Netherlands
Unilever R&D Vlaardingen
Vlaardingen, Netherlands, 3133AT
Sponsors and Collaborators
Unilever R&D
Investigators
Study Director: Edward Haddeman Unilever R&D
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Harry Peters, Unilever R&D
ClinicalTrials.gov Identifier: NCT00776256     History of Changes
Other Study ID Numbers: 07002V 
Study First Received: October 18, 2008
Last Updated: October 20, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Unilever R&D:
satiety
food intake

ClinicalTrials.gov processed this record on September 28, 2016