ObesityNCT02637388
Effects of Beta-glucan on Energy Intake and Satiety
A study testing Oatwell28 Oatwell Original Powder in people with Obesity, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to address the effect of consuming 4g of soluble fibre beta-glucan at breakfast on satiety and food intake. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Oatwell28 Oatwell Original Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Dec 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or Females, aged 18-50 years
- BMI of 20.0 - 29.9 kg/m2 at screening
- Subjects who usually consume breakfast
- Subject is willing to stick to his/her normal habitual diet, excluding the consumption of any unusual high energy-rich or fat-rich meals or undergo periods of fasting during the study period.
- Subject is willing to abstain from strenuous exercise, consume alcoholic drinks and caffeine containing food/drinks 24hours before study days and during study days.
- Ability to pass the Dutch Eating Behaviour Questionnaire (Van Strein et al. 1986) to measure dietary restraint, disinhibition and hunger
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- Subjects understands the study procedures and signs the informed consent to participate in the study
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history or parameters measured during screening.
- Subject has been stable in body-weight within the last 6 months.
- Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period.
Who cannot join
- Postmenopausal females
- Smokers
- Individuals who suffer from (or taking medication for) cardiovascular disease or gastrointestinal disease, including hypertension, hypercholesterolemia, hyperlipidaemia, Crohn's Disease, Irritable bowel syndrome, etc.
- Impaired glucose tolerance/Diabetes mellitus (Fasting blood glucose of ≥5.6mmol/l or 100mg/dL as per NHS criteria)
- Haemoglobin measurements of <120g/L for females and <130g/L for males (as per WHO criteria for anaemia)
- Pregnancy or breastfeeding
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- Those who consume a high fibre diet - consumption of more than 20g/day - Individuals who have known food allergies to ingredients used in study meals (wheat, cow's milk, ham, dairy)
- Needle phobia
- Subjects who are on hypocaloric/hypercaloric diet aiming for weight loss/gain.
- Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine).
- Subject has donated more than 300 mL of blood during the three months prior to screening.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University, Edinburgh
Musselburgh, East Lothain, EH21 6UU
About this study
Official title: The Effect of a Breakfast Meal Containing 4g Oat Beta-glucan on Perceived Satiety and ad Libitum Food Intake in Normal-weight and Overweight Subjects. A Double-blinded, Randomized, Placebo-controlled Cross-over Study.
The purpose of this study is to address the effect of consuming 4g of soluble fibre beta-glucan at breakfast on satiety and food intake.
Read the detailed description
Satiation and satiety are part of the body's complex appetite control system that ultimately play a role in limiting energy intake. Satiation is referred to as the process that leads to the termination of eating, which may be accompanied by feelings of satisfaction. Satiety is the feeling of fullness that persists after eating, with the potential to suppress further energy intake until hunger returns. There is evidence to suggest that increasing gastro-intestinal viscosity improves appetite control and reduces subsequent food intake. Beta-glucan is a soluble fibre proposed to behave this way.
In this double-blinded, randomized, crossover trial, subjective appetite sensations will be measured and blood will be collected at specific time points during the two arms in order to determine hormonal responses. Ad libitum food intake will be recorded. Food diaries will be used to measure dietary intakes.
- Conditions
- Obesity
- Being tested
- Oatwell28 Oatwell Original Powder, Control Breakfast
- Keywords
- Appetite, Beta-glucans, Energy Intake, Glucagon-Like Peptide 1, Glucose, Insulin, Incretins
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oatwell28 Oatwell Original PowderDietary supplement
Control BreakfastDietary supplement
Isocaloric breakfast without added beta-glucans
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: Control Breakfast | Placebo comparator | Breakfast cereal and yoghurt only (placebo, negative control) Receives: Dietary Supplement: Control Breakfast |
| Experimental: beta-Glucan Breakfast | Experimental | Breakfast cereal and yoghurt with the addition of 4g beta-glucan (14.7g Oatwell28 powder) Receives: Dietary Supplement: Oatwell28 Oatwell Original Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in energy intakes
Ad libitum food intake (kilocalories) will be determined during an 'all you can' eat buffet lunch. Food intakes will be measured over 5 days; 3 days prior to the study day, on the day of the study and the day after.
Measured: 1 day
Secondary outcomes (4)
Variation in the feelings of appetite
Measure of the satiating effect for each breakfast with Visual Analog Scale (Area Under the Curve) over time for subjective appetite parameters
Measured: -30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150 minutes
Variation in GLP-1
Measure plasma total glucagon-like peptide 1 (GLP-1) area under the curve (AUC) over time.
Measured: 0, 30, 60, 90 minutes
Variation in insulin
Measure plasma insulin (pg/mL) area under the curve (AUC) over time.
Measured: 0, 30, 60, 90 minutes
Variation in glucose
Measure blood glucose (mmol/L) area under the curve (AUC) over time.
Measured: 0, 30, 60, 90, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Suzanne Zaremba, Queen Margaret University
- Investigators
- Suzanne Zaremba, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637388
- Sponsor's protocol ID
- QueenMUsz2
- Status last verified
- Sep 2016
- First submitted
- 11 Dec 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barone Lumaga R, Azzali D, Fogliano V, Scalfi L, Vitaglione P. Sugar and dietary fibre composition influence, by different hormonal response, the satiating capacity of a fruit-based and a beta-glucan-enriched beverage. Food Funct. 2012 Jan;3(1):67-75. doi: 10.1039/c1fo10065c. Epub 2011 Nov 4.
PubMed 22057424Vitaglione P, Lumaga RB, Montagnese C, Messia MC, Marconi E, Scalfi L. Satiating effect of a barley beta-glucan-enriched snack. J Am Coll Nutr. 2010 Apr;29(2):113-21. doi: 10.1080/07315724.2010.10719824.
PubMed 20679146Vitaglione P, Lumaga RB, Stanzione A, Scalfi L, Fogliano V. beta-Glucan-enriched bread reduces energy intake and modifies plasma ghrelin and peptide YY concentrations in the short term. Appetite. 2009 Dec;53(3):338-44. doi: 10.1016/j.appet.2009.07.013. Epub 2009 Jul 23.
PubMed 19631705Juvonen KR, Salmenkallio-Marttila M, Lyly M, Liukkonen KH, Lahteenmaki L, Laaksonen DE, Uusitupa MI, Herzig KH, Poutanen KS, Karhunen LJ. Semisolid meal enriched in oat bran decreases plasma glucose and insulin levels, but does not change gastrointestinal peptide responses or short-term appetite in healthy subjects. Nutr Metab Cardiovasc Dis. 2011 Sep;21(9):748-56. doi: 10.1016/j.numecd.2010.02.002. Epub 2010 Jun 4.
PubMed 20605427Huang XF, Yu Y, Beck EJ, South T, Li Y, Batterham MJ, Tapsell LC, Chen J. Diet high in oat beta-glucan activates the gut-hypothalamic (PYY(3)(-)(3)(6)-NPY) axis and increases satiety in diet-induced obesity in mice. Mol Nutr Food Res. 2011 Jul;55(7):1118-21. doi: 10.1002/mnfr.201100095. Epub 2011 Jun 20.
PubMed 21688388Steinert RE, Beglinger C, Langhans W. Intestinal GLP-1 and satiation: from man to rodents and back. Int J Obes (Lond). 2016 Feb;40(2):198-205. doi: 10.1038/ijo.2015.172. Epub 2015 Aug 28.
PubMed 26315842Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25.
PubMed 24965303
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Breakfast Meal Containing 4g Oat Beta-glucan on Perceived Satiety and ad Libitum Food Intake in Normal-weight and Overweight Subjects. A Double-blinded, Randomized, Placebo-controlled Cross-over Study.
- ClinicalTrials.gov ID
- NCT02637388
- Acronym / sponsor ID
- QueenMUsz2
- Conditions
- Obesity
- Keywords
- Appetite, Beta-glucans, Energy Intake, Glucagon-Like Peptide 1, Glucose, Insulin, Incretins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Dec 2015 (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 purpose of this study is to address the effect of consuming 4g of soluble fibre beta-glucan at breakfast on satiety and food intake.
Detailed description
Satiation and satiety are part of the body's complex appetite control system that ultimately play a role in limiting energy intake. Satiation is referred to as the process that leads to the termination of eating, which may be accompanied by feelings of satisfaction. Satiety is the feeling of fullness that persists after eating, with the potential to suppress further energy intake until hunger returns. There is evidence to suggest that increasing gastro-intestinal viscosity improves appetite control and reduces subsequent food intake. Beta-glucan is a soluble fibre proposed to behave this way.
In this double-blinded, randomized, crossover trial, subjective appetite sensations will be measured and blood will be collected at specific time points during the two arms in order to determine hormonal responses. Ad libitum food intake will be recorded. Food diaries will be used to measure dietary intakes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: Control Breakfast | Placebo comparator | Dietary Supplement: Control BreakfastBreakfast cereal and yoghurt only (placebo, negative control) |
| Experimental: beta-Glucan Breakfast | Experimental | Dietary Supplement: Oatwell28 Oatwell Original PowderBreakfast cereal and yoghurt with the addition of 4g beta-glucan (14.7g Oatwell28 powder) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males or Females, aged 18-50 years
- BMI of 20.0 - 29.9 kg/m2 at screening
- Subjects who usually consume breakfast
- Subject is willing to stick to his/her normal habitual diet, excluding the consumption of any unusual high energy-rich or fat-rich meals or undergo periods of fasting during the study period.
- Subject is willing to abstain from strenuous exercise, consume alcoholic drinks and caffeine containing food/drinks 24hours before study days and during study days.
Key exclusion criteria (11 listed)
- Postmenopausal females
- Smokers
- Individuals who suffer from (or taking medication for) cardiovascular disease or gastrointestinal disease, including hypertension, hypercholesterolemia, hyperlipidaemia, Crohn's Disease, Irritable bowel syndrome, etc.
- Impaired glucose tolerance/Diabetes mellitus (Fasting blood glucose of ≥5.6mmol/l or 100mg/dL as per NHS criteria)
- Haemoglobin measurements of <120g/L for females and <130g/L for males (as per WHO criteria for anaemia)
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 |
|---|---|---|
| Oatwell28 Oatwell Original Powder | Dietary supplement | Experimental: beta-Glucan Breakfast |
| Control BreakfastIsocaloric breakfast without added beta-glucans | Dietary supplement | Placebo Comparator: Control Breakfast |
Primary outcome
Variation in energy intakes
Time frame: 1 day
Ad libitum food intake (kilocalories) will be determined during an 'all you can' eat buffet lunch. Food intakes will be measured over 5 days; 3 days prior to the study day, on the day of the study and the day after.
4 secondary outcomes
Variation in the feelings of appetite
Time frame: -30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150 minutes
Variation in GLP-1
Time frame: 0, 30, 60, 90 minutes
Variation in insulin
Time frame: 0, 30, 60, 90 minutes
Variation in glucose
Time frame: 0, 30, 60, 90, 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 22057424Barone Lumaga R, Azzali D, Fogliano V, Scalfi L, Vitaglione P. Sugar and dietary fibre composition influence, by different hormonal response, the satiating capacity of a fruit-based and a beta-glucan-enriched beverage. Food Funct. 2012 Jan;3(1):67-75. doi: 10.1039/c1fo10065c. Epub 2011 Nov 4.
- Background: PubMed 20679146Vitaglione P, Lumaga RB, Montagnese C, Messia MC, Marconi E, Scalfi L. Satiating effect of a barley beta-glucan-enriched snack. J Am Coll Nutr. 2010 Apr;29(2):113-21. doi: 10.1080/07315724.2010.10719824.
- Background: PubMed 19631705Vitaglione P, Lumaga RB, Stanzione A, Scalfi L, Fogliano V. beta-Glucan-enriched bread reduces energy intake and modifies plasma ghrelin and peptide YY concentrations in the short term. Appetite. 2009 Dec;53(3):338-44. doi: 10.1016/j.appet.2009.07.013. Epub 2009 Jul 23.
- Background: PubMed 20605427Juvonen KR, Salmenkallio-Marttila M, Lyly M, Liukkonen KH, Lahteenmaki L, Laaksonen DE, Uusitupa MI, Herzig KH, Poutanen KS, Karhunen LJ. Semisolid meal enriched in oat bran decreases plasma glucose and insulin levels, but does not change gastrointestinal peptide responses or short-term appetite in healthy subjects. Nutr Metab Cardiovasc Dis. 2011 Sep;21(9):748-56. doi: 10.1016/j.numecd.2010.02.002. Epub 2010 Jun 4.
- Background: PubMed 21688388Huang XF, Yu Y, Beck EJ, South T, Li Y, Batterham MJ, Tapsell LC, Chen J. Diet high in oat beta-glucan activates the gut-hypothalamic (PYY(3)(-)(3)(6)-NPY) axis and increases satiety in diet-induced obesity in mice. Mol Nutr Food Res. 2011 Jul;55(7):1118-21. doi: 10.1002/mnfr.201100095. Epub 2011 Jun 20.
- Background: PubMed 26315842Steinert RE, Beglinger C, Langhans W. Intestinal GLP-1 and satiation: from man to rodents and back. Int J Obes (Lond). 2016 Feb;40(2):198-205. doi: 10.1038/ijo.2015.172. Epub 2015 Aug 28.
- Background: PubMed 24965303Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25.
- Individual participant dataSharing planned: No
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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.
Suzanne Zaremba principal investigator
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oatwell28 Oatwell Original Powder in people with Obesity, run by Queen Margaret University at 1 site in United Kingdom.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Variation in energy intakes (time frame: 1 day). 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 NCT02637388, which also lists 7 linked publications.
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 27 Sep 2016.