NCT02846454

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

June 20, 2016

Last Update Submit

May 10, 2018

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • 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).

    6hrs

Secondary Outcomes (4)

  • Effects of consuming a composite drink of inulin and arabinoxylan on energy intake

    6hr

  • Effects of consuming a composite drink of inulin and arabinoxylan on anthropometric measurements

    12 weeks

  • Effects of consuming a composite drink of inulin and arabinoxylan on mediating changes in gut microbiota

    28 days

  • Effects of consuming a composite drink of inulin and arabinoxylan on the production of short chain fatty acid production.

    28 days

Study Arms (3)

inulin

EXPERIMENTAL

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

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)

Other: arabinoxylan

Interventions

inulinOTHER

Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g

Also known as: Inulin (Fruitafit IQ)
inulin
arabinoxylanOTHER

Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g

Also known as: arabinoxylan (Naxus)
arabinoxylan

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mr Daniel commane

Reading, Berkshire, RG6 6AH, United Kingdom

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19049655BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 37046122DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Inulinarabinoxylan

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Mike Proven, PhD

    Ethics committee Co-ordinator

    STUDY CHAIR

Central Study Contacts

Daniel M Commane, PhD

CONTACT

0118 378 7108d.m.commane@reading.ac.uk

sineaid M collins, BSC

CONTACT

s.collins@pgr.reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 27, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

GB(1)