Effects of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota (MIXSAT)
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|ClinicalTrials.gov Identifier: NCT02846454|
Recruitment Status : Unknown
Verified May 2018 by Dr Daniel Commane, University of Reading.
Recruitment status was: Recruiting
First Posted : July 27, 2016
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Other: inulin Other: arabinoxylan||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||July 1, 2018|
Investigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB)
Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g
Other Name: Inulin (Fruitafit IQ)
No Intervention: non inulin and arabinoxylan
investigating the satiating effects of a control drink (2.6g/d maltodextrin)
Investigating the satiating effects of consuming 4g/d arabinoxylan (Medium Chain Naxus, BioActor b.v)
Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g
Other Name: arabinoxylan (Naxus)
- 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).
- Effects of consuming a composite drink of inulin and arabinoxylan on energy intake [ Time Frame: 6hr ]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.
- Effects of consuming a composite drink of inulin and arabinoxylan on anthropometric measurements [ Time Frame: 12 weeks ]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).
- Effects of consuming a composite drink of inulin and arabinoxylan on mediating changes in gut microbiota [ Time Frame: 28 days ]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
- Effects of consuming a composite drink of inulin and arabinoxylan on the production of short chain fatty acid production. [ Time Frame: 28 days ]Analysis of SCFA production will be measured in millimolar (mM) by High Performance Liquid Chromotography (HPLC) and analysis using quantitative analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846454
|Contact: Daniel M Commane, PhD||0118 378 firstname.lastname@example.org|
|Contact: sineaid M collins, BSCemail@example.com|
|Study Chair:||Mike Proven, PhD||Ethics committee Co-ordinator|