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

Primary Purpose

Overweight and Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
inulin
arabinoxylan
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

21 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mr Daniel commaneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

inulin

non inulin and arabinoxylan

arabinoxylan

Arm Description

Investigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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
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.

Full Information

First Posted
June 20, 2016
Last Updated
May 10, 2018
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT02846454
Brief Title
Effects of Inulin and Arabinoxylan on Satiety, Energy/Food Intake and Changes in the Human Gut Microbiota
Acronym
MIXSAT
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inulin
Arm Type
Experimental
Arm Description
Investigating the satiating effects of consuming 4g/d inulin (Fruitafit IQ by CHIMAB)
Arm Title
non inulin and arabinoxylan
Arm Type
No Intervention
Arm Description
investigating the satiating effects of a control drink (2.6g/d maltodextrin)
Arm Title
arabinoxylan
Arm Type
Experimental
Arm Description
Investigating the satiating effects of consuming 4g/d arabinoxylan (Medium Chain Naxus, BioActor b.v)
Intervention Type
Other
Intervention Name(s)
inulin
Other Intervention Name(s)
Inulin (Fruitafit IQ)
Intervention Description
Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g
Intervention Type
Other
Intervention Name(s)
arabinoxylan
Other Intervention Name(s)
arabinoxylan (Naxus)
Intervention Description
Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g
Primary Outcome Measure Information:
Title
Effects of consuming a composite drink of inulin and arabinoxylan on subjective satiety scores
Description
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).
Time Frame
6hrs
Secondary Outcome Measure Information:
Title
Effects of consuming a composite drink of inulin and arabinoxylan on energy intake
Description
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.
Time Frame
6hr
Title
Effects of consuming a composite drink of inulin and arabinoxylan on anthropometric measurements
Description
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).
Time Frame
12 weeks
Title
Effects of consuming a composite drink of inulin and arabinoxylan on mediating changes in gut microbiota
Description
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
Time Frame
28 days
Title
Effects of consuming a composite drink of inulin and arabinoxylan on the production of short chain fatty acid production.
Description
Analysis of SCFA production will be measured in millimolar (mM) by High Performance Liquid Chromotography (HPLC) and analysis using quantitative analysis.
Time Frame
28 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel M Commane, PhD
Phone
0118 378 7108
Email
d.m.commane@reading.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
sineaid M collins, BSC
Email
s.collins@pgr.reading.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Proven, PhD
Organizational Affiliation
Ethics committee Co-ordinator
Official's Role
Study Chair
Facility Information:
Facility Name
Mr Daniel commane
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sineaid M collins, BSc
Email
s.collins@pgr.reading.ac.uk
First Name & Middle Initial & Last Name & Degree
Michelle Weech, PhD
Phone
0118 378 7771
Email
m.weech@reading.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19049655
Citation
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.
Results Reference
background
Citation
Benelam, B. Satiation, satiety and their effects on eating behaviour., 2009. British Nutrition Foundation, 34(2).
Results Reference
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Learn more about this trial

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

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