Appetite RegulationNCT00776256
Effects of Oligofructose and Barley on Satiety and Energy Intake
A study testing beta-glucan and fructooligosaccharide in people with Appetite Regulation, run by Unilever R&D at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- beta-glucan and fructooligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2007to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Appetite Regulation
- Being tested
- beta-glucan and fructooligosaccharide
- Keywords
- satiety, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-glucan and fructooligosaccharideDietary supplement
Also called oats, barley, oligofructose
1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | effect of beta-glucan Receives: Dietary Supplement: beta-glucan and fructooligosaccharide |
| 2 | Active comparator | effect of fructo-oligosaccharide Receives: Dietary Supplement: beta-glucan and fructooligosaccharide |
| 3 | Active comparator | effect of beta-glucan and fructooligosaccharide Receives: Dietary Supplement: beta-glucan and fructooligosaccharide |
| 4 | Placebo comparator | no beta-glucan nor fructooligosaccharide Receives: Dietary Supplement: beta-glucan and fructooligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety and food intake
Measured: 2 days each week for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startFeb 2007
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edward Haddeman, Study director, Unilever R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776256
- Sponsor's protocol ID
- 07002V
- Status last verified
- Oct 2008
- First submitted
- 18 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19056555
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake
- ClinicalTrials.gov ID
- NCT00776256
- Acronym / sponsor ID
- 07002V
- Conditions
- Appetite Regulation
- Keywords
- satiety, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: beta-glucan and fructooligosaccharideeffect of beta-glucan |
| 2 | Active comparator | Dietary Supplement: beta-glucan and fructooligosaccharideeffect of fructo-oligosaccharide |
| 3 | Active comparator | Dietary Supplement: beta-glucan and fructooligosaccharideeffect of beta-glucan and fructooligosaccharide |
| 4 | Placebo comparator | Dietary Supplement: beta-glucan and fructooligosaccharideno beta-glucan nor fructooligosaccharide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-glucan and fructooligosaccharideAlso: oats, barley, oligofructose1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2 | Dietary supplement | 1, 2, 3, 4 |
Primary outcome
Satiety and food intake
Time frame: 2 days each week for 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
- Derived from this study: PubMed 19056555Peters 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.
Related trials for Appetite Regulation
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
A Study to Evaluate the Effects of a Dietary Supplement on Weight Management and Appetite Control
Overweight, Obesity
Recruiting
GLycaemic Outcomes With Whey Protein in ageING
Type 2 Diabetes, Appetite Regulation
Recruiting
Eating to Adjust the Timing System
Dietary Intervention
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Haddeman study director
Unilever R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta-glucan and fructooligosaccharide in people with Appetite Regulation, run by Unilever R&D at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satiety and food intake (time frame: 2 days each week for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.