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

May 10, 2018 updated by: Dr Daniel Commane, University of Reading

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: inulin
Investigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB)
Other: inulin
Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g
Other Names:
  • Inulin (Fruitafit IQ)
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)
Other: arabinoxylan
Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g
Other Names:
  • arabinoxylan (Naxus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6hr
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).
12 weeks
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
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
Analysis of SCFA production will be measured in millimolar (mM) by High Performance Liquid Chromotography (HPLC) and analysis using quantitative analysis.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

July 24, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UReading

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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