- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00776256
Effects of Oligofructose and Barley on Satiety and Energy Intake
The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vlaardingen, Netherlands, 3133AT
- Unilever R&D Vlaardingen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
|
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:
|
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
Sponsor
Investigators
- Study Director: Edward Haddeman, Unilever R&D
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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