NCT02041975

Brief Summary

To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

January 10, 2014

Last Update Submit

May 10, 2016

Conditions

Obesity

Keywords

PrebioticsGut healthSatisfaction

Outcome Measures

Primary Outcomes (1)

  • Differences in perceived appetite (assessed using visual analogue scales)

    Within 18 months

Secondary Outcomes (1)

  • Alterations to the relative balance of bacterial groups in faeces (assessed using flow cytometry)

    Within 18 months

Other Outcomes (1)

  • Changes to metabolite and gut hormones responses in plasma (measured using ELISA and other assays)

    Within 18 months

Study Arms (2)

Prebiotic

EXPERIMENTAL

Nutriose FB06 14g/day

Dietary Supplement: Nutriose FB06

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Nutriose FB06DIETARY_SUPPLEMENT

Wheat dextrin soluble fibre

Prebiotic
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 22 and 55 years
  • Healthy (no medical conditions in the last 12 months)
  • BMI between 22.0 and 27.9 kg/m2
  • Non-smokers
  • Not a vegetarian or vegan
  • No antibiotics in the last 6 months
  • Not donated more than 350 ml blood in 4 months prior to or following study

You may not qualify if:

  • Had surgery or suffered a medical condition affecting the circulatory, nervous or digestive systems in the previous 12 months
  • Had suffered a myocardial infarction or stroke in the previous 12 months
  • Suffer from any blood-clotting disorder or prescription of any medication affecting blood clotting
  • Suffer from any metabolic disorders (e.g. diabetes, metabolic syndrome or hypertension)
  • Any requirement to take long-term medication, especially those active on the gastro-intestinal tract or for cardio-vascular disease \[including proton pump inhibitors (e.g. Omeprazole, Esomeprazole, Lansoprazole or Pantoprazole), non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen or diclofenac) or anti-anxiety medication (e.g. benzodiazepine)\]
  • Use of antibiotics within the previous 6 months
  • Any dietary restrictions or on a weight reducing diet
  • Irregular eating patterns and those not consuming breakfast
  • Any food allergies (e.g. milk protein allergies) or intolerances (e.g. lactose)
  • Use of medication which affects food intake or behaviour (e.g. anti-depressants)
  • Use of medication likely to affect taste, smell or appetite
  • Use of cholesterol lowering drugs/functional foods (e.g. Flora pro-activ)
  • Dietary fibre consumption \> 20 g/d
  • Those that dislike the study foods and beverages
  • Three Factor Eating Questionnaire (TFEQ) Factor 1 score \>13
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (1)

  • Hobden MR, Commane DM, Guerin-Deremaux L, Wils D, Thabuis C, Martin-Morales A, Wolfram S, Diaz A, Collins S, Morais I, Rowland IR, Gibson GR, Kennedy OB. Impact of dietary supplementation with resistant dextrin (NUTRIOSE(R)) on satiety, glycaemia, and related endpoints, in healthy adults. Eur J Nutr. 2021 Dec;60(8):4635-4643. doi: 10.1007/s00394-021-02618-9. Epub 2021 Jun 25.

    PMID: 34170392DERIVED

MeSH Terms

Conditions

ObesityPersonal Satisfaction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Orla Kennedy

    University of Reading

    PRINCIPAL INVESTIGATOR

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
Mr

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 22, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

GB(1)