Effects of Prebiotic-based Snacks on the Gut Microbiota and Perceived 'Satisfaction' (NutriSAT)

May 10, 2016 updated by: Mark Hobden, University of Reading

Investigating the Effects of Prebiotic-based Snacks on Perceived Feelings of 'Satisfaction' and on the Balance of Bacteria in the Human Gut (NutriSAT)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The role of the bacteria that reside in the human gut play in human health and disease is of increasing importance. Evidence gathered over recent decades' shows that certain bacteria can improve resistance to gut infections, reduce cholesterol levels, synthesise vitamins and improve the immune response. The potential to modulate the relative balance of these so-called 'beneficial' bacteria has been demonstrated through the use of certain fibre sources termed prebiotics. In addition there is interest to understand how snacks containing these fibre sources may affect levels of 'satisfaction' between meals. The current study will address these issues and lead to a greater understanding of the role that prebiotics may play in gut health and overall metabolism.

Study Type

Interventional

Enrollment (Actual)

47

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

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • University of Reading

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

22 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria -

  • 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

Exclusion Criteria -

  • 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
  • Use of any vitamin supplements or fish oil capsules
  • A history of alcohol or drug misuse (the average daily number of units of alcohol considered as acceptable is 2-3 units women; 3-4 units men)
  • Smoking
  • Athletes in training (> 8 h exercise/week)
  • Amount of sleep each night (<5 hours/night)
  • Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
  • Involvement in a study involving an experimental drug/medication within 4 weeks prior to entry to the study
  • History of chronic constipation or diarrhoea, or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
  • Intake of other supplementary prebiotics (such as oligosaccharides, e.g. FOS, GOS) or probiotics, drugs active on gastrointestinal motility such as antidiarrheals (e.g. medicines containing loperamide, bismuth subsalicyte or atropine/diphenoxylate), medication for abdominal pain and intestinal discomfort (e.g. duspatalin) or laxatives of any class (medications containing e.g. polyethylene glycol 3350, bisacodyl, methylcellulose or lactulose) during or within the four weeks prior to the start of the study
  • Aged below 22 or over 55 years
  • Have a Body Mass Index (BMI) of less than 22 or more than 27.9 kg/m2 [for volunteers of Asian origin; BMI of less than 21, or between to 23 to 25, or above 27 kg/m2].
  • Blood pressure > 160/90 mmHg
  • Vegan or vegetarian
  • Donated > 350 ml of blood within the 4 months prior to the study or plan on donating > 350 ml of blood within the 4 months following the study.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Maltodextrin
Dietary supplement: Placebo
Experimental: Prebiotic
Nutriose FB06 14g/day
Dietary supplement: Nutriose FB06
Wheat dextrin soluble fibre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in perceived appetite (assessed using visual analogue scales)
Time Frame: Within 18 months
Within 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Alterations to the relative balance of bacterial groups in faeces (assessed using flow cytometry)
Time Frame: Within 18 months
Within 18 months

Other Outcome Measures

Outcome Measure
Time Frame
Changes to metabolite and gut hormones responses in plasma (measured using ELISA and other assays)
Time Frame: Within 18 months
Within 18 months

Collaborators and Investigators

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

Sponsor

University of Reading

Collaborators

Roquette Freres

Investigators

  • Principal Investigator: Orla Kennedy, University of Reading

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

October 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H5117800
  • Ethics No. 11/08 (Other Identifier: University of Reading)

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.

Clinical Trials on Obesity

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe