Effects of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota (MIXSAT)

• ClinicalTrials.gov Identifier: NCT02846454
• Recruitment Status: Unknown
• First Posted: July 27, 2016
• Last Update Posted: May 11, 2018
• Sponsor: University of Reading
• Information provided by (Responsible Party): Dr Daniel Commane, University of Reading

Tracking Information

• First Submitted Date: June 20, 2016
• First Posted Date: July 27, 2016
• Last Update Posted Date: May 11, 2018
• Study Start Date: August 2016
• Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2016)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 24, 2016)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota
• 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
• Brief 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 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Overweight and Obesity

Intervention

• Other: inulin
  Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g
  Other Name: Inulin (Fruitafit IQ)
• Other: arabinoxylan
  Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g
  Other Name: arabinoxylan (Naxus)

Study Arms

• Experimental: inulin
  Investigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB)
  Intervention: Other: inulin
• No Intervention: non inulin and arabinoxylan
  investigating the satiating effects of a control drink (2.6g/d maltodextrin)
• Experimental: arabinoxylan
  Investigating the satiating effects of consuming 4g/d arabinoxylan (Medium Chain Naxus, BioActor b.v)
  Intervention: Other: arabinoxylan

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.
• Benelam, B. Satiation, satiety and their effects on eating behaviour., 2009. British Nutrition Foundation, 34(2).

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 24, 2016): 33
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2018
• Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02846454
• Other Study ID Numbers: UReading
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Dr Daniel Commane, University of Reading
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Reading
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Mike Proven, PhD; Ethics committee Co-ordinator

• PRS Account: University of Reading
• Verification Date: May 2018