Overweight and ObesityMIXSATNCT02846454
Effects of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota
A study testing inulin and arabinoxylan in people with Overweight and Obesity, run by University of Reading at 1 site in United Kingdom.
Trial summary
This proposed randomized, double blinded 12 week crossover human feeding study aims to investigate the effects of consuming a composite drink of inulin and arabinoxylan on satiety by measuring appetite biomarkers such as subjective satiety, energy/food intake and changes in the human gut microbiota in healthy weight… Read more about this study
- Who is it for?
- Ages 21 to 55 years, men only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- inulin and arabinoxylan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to 1 Jul 2018
- 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 21 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males
- 21-55 years old
- Body Mass Index (BMI) 19.5-24.5kg/m2
- Overall healthy
- Weight Stable (<3 kg change in the past 4 months, before the trial).
Who cannot join
- Smokers
- drink more than 28 units of alcohol per week (i.e. not more than 14 pints of beer or 28 small glasses of wine)
- Restricted diet such as weight loss, vegetarian/vegan or taking dietary supplements such as prebiotics (such as oligosaccharides ie Fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS) or probiotics (ie Actimel)), not eating breakfast and >25g/d dietary fibre consumption as well as those with food allergies
- Gastrointestinal procedure or surgery in the past three months.
- Gastrointestinal disorders: celiac disease, Intestinal Bowel Disease (IBD), irritable bowel syndrome (IBS), chronic constipation, diverticulitis or a history of chronic constipation, diarrhoea, or other chronic gastrointestinal complaints
- Disorders of swallowing, severe dysphagia to food or pills.
Show all 14Show fewer
- Appetite modulator drugs: orlistat, sibutramine, rimonabant.
- Mood disorder medications: antidepressants, lithium.
- Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or coagulation disease.
- Psychiatric disorder: severe depression, bulimia, anorexia, schizophrenia, bipolar disorder.
- Pregnancy
- Others: oral antidiabetics, insulin, digoxin, thyroid hormones, antibiotics, steroids or immunosuppressants, recreational substances.
- Use of implanted or portable electro-mechanical device such as cardiac peacemaker or infusion pump.
- Blood donor in the past 3 months.
Trial locations and contacts
1 site in 1 country.
sineaid M collins, BSC contact
United Kingdom1 site, 1 recruiting
- Recruiting
Mr Daniel commane
Reading, Berkshire, RG6 6AH
Sineaid M collins, BSc, s.collins@pgr.reading.ac.uk
Michelle Weech, PhD, 0118 378 7771, m.weech@reading.ac.uk
About this study
Official title: Investigating the Effects of a Composite Drink of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota
This proposed randomized, double blinded 12 week crossover human feeding study aims to investigate the effects of consuming a composite drink of inulin and arabinoxylan on satiety by measuring appetite biomarkers such as subjective satiety, energy/food intake and changes in the human gut microbiota in healthy weight males (22 to 24.9kg/m2)
Read the detailed description
Research that focuses on the mechanisms involved in appetite regulation is topical given the emergence of the worldwide obesity epidemic. Understanding the physiological processes associated with the onset of obesity is essential for the development of effective anti-obesity strategies. There is evidence that people who consume a diet high in non-starch polysaccharides (NSPs) have a lower body mass index (BMI) than those that do not.
A 2009 review of fibre and satiety by Bridget Benelam, 2009 focused on different types of fibre and the significant impact they may have on satiety and/or energy intake, through fermentation of fibre such as non starch polysaccharides in the colon by gut bacterial groups such as Bifidobacterium. non starch polysaccharides and other fibre sources are poorly digested by human enzymes in the small intestine but are degraded by large groups of bacteria in the large bowel. One of the beneficial outcomes of this fermentation of fibre that gut bacteria produce of metabolites called short chain fatty acids (SCFA) thought to affect appetite regulation by stimulating production of satiety hormones that can help you feel full. Acetate and propionate are two of these metabolites highlighted as potential mediator of satiety.
Some fibres are called prebiotics as they act as selective sources for beneficial gut bacteria. However Western populations do not consume natural prebiotics in high quantities in their diet and the overall intake of fibre is also low. Therefore, in this study, the investigators aim to utilise a mixture of prebiotics in order to increase the growth and/or activity of commensal gut bacteria and SCFA production in human volunteers and to assess the effects of consumption on satiety.
Testing the impact of a composite mix of inulin and arabinoxylan in a human study will help determine the effect it has on appetite regulation, ad libitum food intake, SCFA production, anthropometric measurements, cognitive state (e.g. mood) and composition of the gut microbiota.
The study design is a 12 week randomized, human feeding study, with a crossover design testing a composite mix of inulin and arabinoxylan against an equivalent energy matched (kcal) maltodextrin control drink in 33 healthy weight (22 to 24.9kg/m2) males aged between 21-55. Volunteers will be enrolled to treatment or placebo for four weeks, with a four week wash out before the crossover. the primary endpoint, satiety following a test meal challenge will be measured on four occasions throughout the study. Anthropometry measures, dietary intake, body weight and blood pressure will be monitored throughout the study. Faecal and urine will be collected at baseline and at the end of each treatment period.
- Conditions
- Overweight and Obesity
- Being tested
- inulin, arabinoxylan
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinOther
Also called Inulin (Fruitafit IQ)
Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g
arabinoxylanOther
Also called arabinoxylan (Naxus)
Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g
| Study group | Role | What they receive |
|---|---|---|
| inulin | Experimental | Investigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB) Receives: Other: inulin |
| non inulin and arabinoxylan | No intervention | investigating the satiating effects of a control drink (2.6g/d maltodextrin) |
| arabinoxylan | Experimental | Investigating the satiating effects of consuming 4g/d arabinoxylan (Medium Chain Naxus, BioActor b.v) Receives: Other: arabinoxylan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of consuming a composite drink of inulin and arabinoxylan on subjective satiety scores
The volunteers will randomized to receive either control or treatment drink and asked to consume this twice daily for 28 days, followed by a 28 day washout, the alternate drink will then be consumed for a further 28 days. Visual analogue scale will be used to measure subjective satiety scores during 4 half day study days lasting 6hrs at the beginning and end of each treatment period at a designated nutrition unit (Hugh Sinclair Nutrition unit, Reading University).
Measured: 6hrs
Secondary outcomes (4)
Effects of consuming a composite drink of inulin and arabinoxylan on energy intake
Energy intake will be measured during each of the 4 study days. A test meal of cheese and tomato pizza will be given ad libitum as a lunch meal and the energy intake (KJ) will be measured by weighing the food before and after consumption.
Measured: 6hr
Effects of consuming a composite drink of inulin and arabinoxylan on anthropometric measurements
In order to see if consumption of inulin and arabinoxylan have impacted anthropometric measurements, these will also be taken at the beginning of each of the 4 study days including height (m), weight (kg), waist and hip circumference (cm).
Measured: 12 weeks
Effects of consuming a composite drink of inulin and arabinoxylan on mediating changes in gut microbiota
To assess the changes in faecal bacteria populations using fluorescent in situ hybridisation (FISH) will be used in which molecular probes target 16S ribosomal ribonucleic acid (rRNA),labelled with the fluorescent Cy3 dye (Sigma Aldrich Ltd., Poole, Dorset, UK) and as previously described by Martín-Peláez S et al 2008
Measured: 28 days
Effects of consuming a composite drink of inulin and arabinoxylan on the production of short chain fatty acid production.
Analysis of SCFA production will be measured in millimolar (mM) by High Performance Liquid Chromotography (HPLC) and analysis using quantitative analysis.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Daniel Commane, University of Reading
- Investigators
- Mike Proven, PhD, Study chair, Ethics committee Co-ordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846454
- Sponsor's protocol ID
- UReading
- Acronym
- MIXSAT
- Status last verified
- May 2018
- First submitted
- 20 Jun 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Martin-Pelaez S, Gibson GR, Martin-Orue SM, Klinder A, Rastall RA, La Ragione RM, Woodward MJ, Costabile A. In vitro fermentation of carbohydrates by porcine faecal inocula and their influence on Salmonella Typhimurium growth in batch culture systems. FEMS Microbiol Ecol. 2008 Dec;66(3):608-19. doi: 10.1111/j.1574-6941.2008.00610.x.
PubMed 19049655Benelam, B. Satiation, satiety and their effects on eating behaviour., 2009. British Nutrition Foundation, 34(2).
Collins SM, Gibson GR, Stainton GN, Bertocco A, Kennedy OB, Walton GE, Commane DM. Chronic consumption of a blend of inulin and arabinoxylan reduces energy intake in an ad libitum meal but does not influence perceptions of appetite and satiety: a randomised control-controlled crossover trial. Eur J Nutr. 2023 Aug;62(5):2205-2215. doi: 10.1007/s00394-023-03136-6. Epub 2023 Apr 12.
PubMed 37046122
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of a Composite Drink of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota
- ClinicalTrials.gov ID
- NCT02846454
- Acronym / sponsor ID
- MIXSAT / UReading
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 27 Jul 2016 (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.
This proposed randomized, double blinded 12 week crossover human feeding study aims to investigate the effects of consuming a composite drink of inulin and arabinoxylan on satiety by measuring appetite biomarkers such as subjective satiety, energy/food intake and changes in the human gut microbiota in healthy weight males (22 to 24.9kg/m2)
Detailed description
Research that focuses on the mechanisms involved in appetite regulation is topical given the emergence of the worldwide obesity epidemic. Understanding the physiological processes associated with the onset of obesity is essential for the development of effective anti-obesity strategies. There is evidence that people who consume a diet high in non-starch polysaccharides (NSPs) have a lower body mass index (BMI) than those that do not.
A 2009 review of fibre and satiety by Bridget Benelam, 2009 focused on different types of fibre and the significant impact they may have on satiety and/or energy intake, through fermentation of fibre such as non starch polysaccharides in the colon by gut bacterial groups such as Bifidobacterium. non starch polysaccharides and other fibre sources are poorly digested by human enzymes in the small intestine but are degraded by large groups of bacteria in the large bowel. One of the beneficial outcomes of this fermentation of fibre that gut bacteria produce of metabolites called short chain fatty acids (SCFA) thought to affect appetite regulation by stimulating production of satiety hormones that can help you feel full. Acetate and propionate are two of these metabolites highlighted as potential mediator of satiety.
Some fibres are called prebiotics as they act as selective sources for beneficial gut bacteria. However Western populations do not consume natural prebiotics in high quantities in their diet and the overall intake of fibre is also low. Therefore, in this study, the investigators aim to utilise a mixture of prebiotics in order to increase the growth and/or activity of commensal gut bacteria and SCFA production in human volunteers and to assess the effects of consumption on satiety.
Testing the impact of a composite mix of inulin and arabinoxylan in a human study will help determine the effect it has on appetite regulation, ad libitum food intake, SCFA production, anthropometric measurements, cognitive state (e.g. mood) and composition of the gut microbiota.
The study design is a 12 week randomized, human feeding study, with a crossover design testing a composite mix of inulin and arabinoxylan against an equivalent energy matched (kcal) maltodextrin control drink in 33 healthy weight (22 to 24.9kg/m2) males aged between 21-55. Volunteers will be enrolled to treatment or placebo for four weeks, with a four week wash out before the crossover. the primary endpoint, satiety following a test meal challenge will be measured on four occasions throughout the study. Anthropometry measures, dietary intake, body weight and blood pressure will be monitored throughout the study. Faecal and urine will be collected at baseline and at the end of each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inulin | Experimental | Other: inulinInvestigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB) |
| non inulin and arabinoxylan | No intervention | –investigating the satiating effects of a control drink (2.6g/d maltodextrin) |
| arabinoxylan | Experimental | Other: arabinoxylanInvestigating the satiating effects of consuming 4g/d arabinoxylan (Medium Chain Naxus, BioActor b.v) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males
- 21-55 years old
- Body Mass Index (BMI) 19.5-24.5kg/m2
- Overall healthy
- Weight Stable (<3 kg change in the past 4 months, before the trial).
Key exclusion criteria (14 listed)
- Smokers
- drink more than 28 units of alcohol per week (i.e. not more than 14 pints of beer or 28 small glasses of wine)
- Restricted diet such as weight loss, vegetarian/vegan or taking dietary supplements such as prebiotics (such as oligosaccharides ie Fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS) or probiotics (ie Actimel)), not eating breakfast and >25g/d dietary fibre consumption as well as those with food allergies
- Gastrointestinal procedure or surgery in the past three months.
- Gastrointestinal disorders: celiac disease, Intestinal Bowel Disease (IBD), irritable bowel syndrome (IBS), chronic constipation, diverticulitis or a history of chronic constipation, diarrhoea, or other chronic gastrointestinal complaints
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 |
|---|---|---|
| inulinAlso: Inulin (Fruitafit IQ)Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g | Other | inulin |
| arabinoxylanAlso: arabinoxylan (Naxus)Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g | Other | arabinoxylan |
Primary outcome
Effects of consuming a composite drink of inulin and arabinoxylan on subjective satiety scores
Time frame: 6hrs
The volunteers will randomized to receive either control or treatment drink and asked to consume this twice daily for 28 days, followed by a 28 day washout, the alternate drink will then be consumed for a further 28 days. Visual analogue scale will be used to measure subjective satiety scores during 4 half day study days lasting 6hrs at the beginning and end of each treatment period at a designated nutrition unit (Hugh Sinclair Nutrition unit, Reading University).
4 secondary outcomes
Effects of consuming a composite drink of inulin and arabinoxylan on energy intake
Time frame: 6hr
Effects of consuming a composite drink of inulin and arabinoxylan on anthropometric measurements
Time frame: 12 weeks
Effects of consuming a composite drink of inulin and arabinoxylan on mediating changes in gut microbiota
Time frame: 28 days
Effects of consuming a composite drink of inulin and arabinoxylan on the production of short chain fatty acid production.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 19049655Martin-Pelaez S, Gibson GR, Martin-Orue SM, Klinder A, Rastall RA, La Ragione RM, Woodward MJ, Costabile A. In vitro fermentation of carbohydrates by porcine faecal inocula and their influence on Salmonella Typhimurium growth in batch culture systems. FEMS Microbiol Ecol. 2008 Dec;66(3):608-19. doi: 10.1111/j.1574-6941.2008.00610.x.
- BackgroundBenelam, B. Satiation, satiety and their effects on eating behaviour., 2009. British Nutrition Foundation, 34(2).
- Derived from this study: PubMed 37046122Collins SM, Gibson GR, Stainton GN, Bertocco A, Kennedy OB, Walton GE, Commane DM. Chronic consumption of a blend of inulin and arabinoxylan reduces energy intake in an ad libitum meal but does not influence perceptions of appetite and satiety: a randomised control-controlled crossover trial. Eur J Nutr. 2023 Aug;62(5):2205-2215. doi: 10.1007/s00394-023-03136-6. Epub 2023 Apr 12.
- Individual participant dataSharing planned: Undecided
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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.
sineaid M collins, BSC contact
Mike Proven, PhD study chair
Ethics committee Co-ordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin and arabinoxylan in people with Overweight and Obesity, run by University of Reading 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 5 inclusion and 14 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 11 May 2018. 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. 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?
Contact Daniel M Commane, PhD (0118 378 7108, d.m.commane@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of consuming a composite drink of inulin and arabinoxylan on subjective satiety scores (time frame: 6hrs). 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 NCT02846454, which also lists 3 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 11 May 2018.