ObesityNutriSATNCT02041975
Effects of Prebiotic-based Snacks on the Gut Microbiota and Perceived 'Satisfaction'
A study testing Nutriose FB06 in people with Obesity, run by University of Reading at 1 site in United Kingdom.
Trial summary
To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutriose FB06
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Nutriose FB06, Placebo
- Keywords
- Prebiotics, Gut health, Satisfaction
- Medical subject headings
- Obesity, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutriose FB06Dietary supplement
Wheat dextrin soluble fibre
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Nutriose FB06 14g/day Receives: Dietary Supplement: Nutriose FB06 |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in perceived appetite (assessed using visual analogue scales)
Measured: Within 18 months
Secondary outcomes (1)
Alterations to the relative balance of bacterial groups in faeces (assessed using flow cytometry)
Measured: Within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Roquette Freres
- Responsible party
- Principal investigator, Mark Hobden, University of Reading
- Investigators
- Orla Kennedy, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041975
- Sponsor's protocol ID
- H5117800
- Other IDs
- Ethics No. 11/08
- Acronym
- NutriSAT
- Status last verified
- May 2016
- First submitted
- 10 Jan 2014
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34170392
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Prebiotic-based Snacks on Perceived Feelings of 'Satisfaction' and on the Balance of Bacteria in the Human Gut (NutriSAT)
- ClinicalTrials.gov ID
- NCT02041975
- Acronym / sponsor ID
- NutriSAT / H5117800
- Conditions
- Obesity
- Keywords
- Prebiotics, Gut health, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Roquette Freres
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: Nutriose FB06Nutriose FB06 14g/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (29 listed)
- 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)]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutriose FB06Wheat dextrin soluble fibre | Dietary supplement | Prebiotic |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Differences in perceived appetite (assessed using visual analogue scales)
Time frame: Within 18 months
1 secondary outcome
Alterations to the relative balance of bacterial groups in faeces (assessed using flow cytometry)
Time frame: Within 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Derived from this study: PubMed 34170392Hobden 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orla Kennedy principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutriose FB06 in people with Obesity, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in perceived appetite (assessed using visual analogue scales) (time frame: Within 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.